Innovation Pharmaceuticals Inc (IPIX)

[frenchbroad]

I think Ipix has a very high price intention for a Brilacidin and Kevetrin partner. Perhaps it is too high so far. The Alfasigma partnership is worth up to USD $24 million plus royalties and this is for a super small market indication.

Here is some helpful information for you from Switzerland on Brilacidin from December. But the format of the tables is not super good. I add some underline.

Brilacidin - Alfasigma/Innovation
Pharmaceuticals
Alternative Names: Brilacidin tetrahydrochloride; Brilacidin-Ocular; Brilacidin-OM;
Brilacidin-Otic; Defensin-mimetic - Innovation Pharmaceuticals; HDP-mimic - Innovation
Pharmaceuticals; Host defense protein-mimic - Innovation Pharmaceuticals; PMX-30063
Latest Information Update: 03 Dec 2021
At a glance
Originator PolyMedix
Developer Innovation Pharmaceuticals
Class Amides; Anti-infectives; Anti-inflammatories; Antiacnes; Antibacterials; Antivirals; Foot
disorder therapies; Guanidines; Peptidomimetics; Pyrimidines; Pyrrolidines; Skin disorder therapies;
Small molecules
Mechanism of Action Cell membrane permeability enhancers; Cell membrane structure modulators;
Immunomodulators; Type 4 cyclic nucleotide phosphodiesterase inhibitors; Virus internalisation
inhibitors
Orphan Drug Status No
New Molecular Entity Yes
Available For Licensing Yes - COVID 2019 infections
Highest Development Phases
Phase II COVID 2019 infections; Skin and soft tissue infections; Stomatitis; Ulcerative proctitis
Phase I Inflammatory bowel diseases
Preclinical Acne; Alphavirus infections; Atopic dermatitis; Bunyavirus infections; Coronavirus
infections; Ebola virus infections; Hidradenitis suppurativa; Marburg virus disease; Nipah virus
infections; West Nile virus infections; Zika virus infection
No development reported Diabetic foot ulcer; Otitis; Wounds
Discontinued Intestinal infections; Ophthalmic infections; Ulcerative colitis
Most Recent Events
18 Nov 2021 Innovation Pharmaceuticals announces compassionate use of brilacidin for COVID-19
infections
18 Nov 2021 Innovation Pharmaceuticals plans a phase III trial for Oral mucositis in 2022
25 Oct 2021 Preclinical trials in Ebola virus infections in USA (unspecified route)
Development Overview
Introduction
Brilacidin is a non-peptidic, synthetic, amphiphilic, small molecule, defensin biomimetic, being developed by
Innovation Pharmaceuticals (formerly Cellceutix), for the treatment of inflammatory bowel diseases, ulcerative
proctitis, ulcerative proctosigmoiditis, atopic dermatitis, viral infections including COVID-2019 infections,
bunyavirus infections, alphavirus infections, Ebola virus infection, Marburg virus disease, Nipah virus infection, West
Nile virus infection, Zika virus infection, acne, hidradenitis suppurativa, pan-staphylococcal infections, including
methicillin-resistant strains (MRSA) and for the prevention of stomatitis (oral mucositis). Brilacidin directly lyses the
bacterial cell membrane by penetrating into it resulting in disruption of barrier and membrane-associated metabolic
functions and subsequent bacterial death. It also induces misfolding of cytoplasmic protein. The drug lessens
inflammation and promotes healing. It is effective against both rapid growth phase and stationary phases of bacteria
and has the potential to function as a single-dose therapy against multi-drug resistant bacteria or superbugs. Thus,
brilacidin is capable of disrupting biofilms and has the potential to be used for biofilm-related infections caused by
. It is active against both gram-positive and gram-negative bacteria. Brilacidin Staphylococcus aureus is not intended
for mycobacterial infections. The product is designed to offer advantages such as a low probability for drug
resistance, broad-spectrum activity, ability for single-dose intravenous administration and inexpensive to produce.
Brilacidin’s antiviral mechanism of action is its ability to attack the coronavirus directly by disrupting viral membrane
integrity. Clinical development of intravenous formulation is underway in Canada, Russia, Ukraine and the US for the
treatment of acute bacterial skin and skin structure infections (ABSSSIs). Clinical development of brilacidin oral rinse
(topical formulation) is underway for the prevention of stomatitis in the US. Clinical development of a retention
enema (rectal formulation) of brilacidin is underway in the US. Clinical development of tablet formulation is ongoing
for the treatment of inflammatory bowel diseases and ulcerative proctitis in the UK and the US, respectively. Clinical
development for COVID-2019 infections is ongoing in the US and Russia. Preclinical development for coronavirus
infections, bunyavirus infections and alphavirus-infections, is ongoing in the US. Preclinical development for the
treatment of acne, inflammatory bowel disease (oral formulation), atopic dermatitis and hidradenitis suppurativa is
underway in the US.
Innovation Pharmaceuticals was also developing Brilacidin as a vaccine for COVID-2019 infections [see Adis Insight
Drug profile 800057896(Brilacidin coronavirus vaccine Innovation Pharmaceuticals)].
Preclinical development was underway for the treatment of intestinal infections and ophthalmic infections, but
development was discontinued. Preclinical development was ongoing for diabetic foot ulcer, otitis and wounds,
however, no recent development has been reported.
Brilacidin is the first defensin mimetic antibiotic compound to enter human clinical trials for systemic use. The
compound emerged from a PolyMedix research programme [see AdisInsight drug profile 800020520(Research
programme defensin mimetic therapeutics Innovation Pharmaceuticals)] that focused on anti-infectives, which is now
owned by Innovation Pharmaceuticals. The company is developing an oral formulation of brilacidin for the treatment
of extensive forms of inflammatory bowel diseases including Crohn's disease, and a topical formulation of brilacidin
for inflammation and immunologic conditions, including atopic dermatitis and acne.
In June 2017, Cellceutix changed its name to Innovation Pharmaceuticals[1].
Innovation Pharmaceuticals is looking for partnership opportunities for the brilacidin in COVID-19 infections[2].
Company Agreements
In July 2019, Innovation Pharmaceuticals entered into a license agreement with Alfasigma to develop and
commercialise locally-administered brilacidin globally, for the treatment of ulcerative proctitis/ulcerative
proctosigmoiditis (UP/UPS). Innovation Pharmaceuticals will receive an initial payment from Alfasigma, and will be
eligible for additional payments based on certain milestones, totaling over $US 24 million, and receive a 6% royalty
(net sales) based on the successful marketing of brilacidin for UP/UPS. The agreement also includes a Right of First
Refusal for brilacidin for the treatment of more extensive forms of inflammatory bowel disease (IBD), such as
ulcerative colitis and Crohn’s disease, and a right of first negotiation for brilacidin in other gastrointestinal
indications.[3]
Innovation Pharmaceuticals, in June 2019, entered into an agreement with Bio-Images Drug Delivery (BDD) Pharma,
for the development of tablets for targeted oral delivery of brilacidin to the colon. These tablets will be developed by
utilising BDD pharam's proprietary, multi-core timed-release OralogiK™ technology that employs controlled erosion
of a time-dependent barrier layer during small intestine transit to provide effective colon targeting. As per the
agreement terms, BDD will provide further expertise and resources by collaborating with the Innovation
Pharmaceuticals to accelerate initiation of clinical trials.
[4]
In July 2018, Innovation Pharmaceuticals entered into a drug product manufacturing contract with CoreRx to
formulate and package brilacidin into granular form in unit dose sachets. The convenient, portable, quick-mixing
“instant” brilacidin sachets will be used in clinical trials conducted to treat severe oral mucositis (WHO Grade 3) in
head and neck cancer patients receiving chemoradiation therapy.[5]
In October 2021, Innovation Pharmaceuticals announced that in collaboration with the US government scientists, in
vitro studies of brilacidin in 20 acutely infectious viruses including Ebola, Marburg, Nipah, West Nile and Zika[6].
In November 2014, Cellceutix reported that it has entered into an agreement with a division of one of the largest US
pharmaceutical companies to test whether the use of brilacidin as a component of certain implanted devices can
prevent infection. The material transfer agreement does not include the pharmaceutical use of brilacidin for the
treatment of infections or other diseases. The final contract is subject of brilacidin getting approved by the US
FDA[7].
Cellceutix reported in February 2014 that it had selected Dr. Reddy's Custom Pharmaceutical Services for the
formulation of brilacidin for use in ophthalmic and otitis infections[8].
In April 2013, PolyMedix filed for Chapter 7 bankruptcy with the Bankruptcy Court for the District of Delaware. In
August 2013, Cellceutix made a "stalking horse" offer for the purchase of PolyMedix's assets, following a due
diligence process. The asset purchase agreement was approved by the Bankruptcy Court for the District of Delaware
in September 2013, which involved a cash payment of $US2.1 million and 1.4 million shares of Cellceutix stock;
none of PolyMedix's debt was assumed by Cellceutix[9].
To design compounds like brilacidin, PolyMedix licensed a proprietary computational drug design technology
developed at the University of Pennsylvania.
Key Development Milestones
Cellceutix reported in August 2014 that it had stabilised the formulation of brilacidin, eliminating the need for
refrigeration and allowing storage at room temperature. This breakthrough positions the company to proceed with
development for the treatment of diabetic foot ulcers, followed by ophthalmic and otic formulations[10].
Innovation Pharmaceuticals announced that formulation development plans include foam and/or gel for the treatment
of ulcerative proctitis/ulcerative proctosigmoiditis (Innovation Pharmaceuticals pipeline, February 2021)[11].
COVID-2019 infections
In July 2021, Innovation Pharmaceuticals completed a phase II trial which evaluated the efficacy and safety of
brilacidin in hospitalised patients with COVID-2019 infections (NCT04784897; IPI-BRIc-201). The primary
endpoint was time to sustained recovery through day 29, using a clinical status ordinal scale based on that used in the
series of National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trials
(ACTTs). The randomised, double-blind, placebo-controlled trial initiated in February 2021 completed enrolment of
120 patients in the US and Russia, in early June 2021. Earlier in December 2020, US FDA approved Investigational
New Drug application (IND) for initiation of phase II trial for brilacidin in the patients with moderate to severe
COVID-2019 infection. In November 2020, Innovation Pharmaceuticals announced receipt the of written feedback
from the US Food and Drug Administration (FDA) for the phase II trial of brilacidin, for the treatment of hospitalised
patients with COVID-2019 infections. The FDA response completes the Pre-Investigational New Drug (Pre-IND)
process. In October 2020, the US FDA confirmed request of Innovation Pharmaceuticals for the pre-IND meeting. In
the meeting, the company will seek regulatory guidance on the randomised, double-blind, placebo-controlled phase II
trial from the agency. The multicentre trial is designed to enroll 120 patients. The active and placebo arms of the trial
will recruit approximately 60 patients respectively. Earlier in the similar week, Innovation Pharmaceuticals had
submitted a application, requesting the meeting. In November 2020, Innovation Pharmaceuticals announced the
submission of an overseas clinical trial application to the governing health agency to proceed with initiation of a
phase II trial of intravenous brilacidin for the treatment of hospitalised patients with COVID-2019 infections. The
company also intends to submit an IND application to the US FDA for the same trial. As of April 2021, upon recently
completing a scheduled review of interim safety data from the trial, an independent Data Monitoring Committee
(DMC) recommended increasing the dosing regimen of brilacidin from three days to five days of treatment, which
will maximise the therapeutic benefits and provide a comparison with five-day remdesivir. The longer duration of
systemic brilacidin exposure at a level that can strongly suppress SARS-CoV-2 virus replication, and associated
symptoms, and thus maximize therapeutic benefits. The last patient follow-up visit occurred on July
2021.[12][13][14][15][16][17][18][19][20][21][22][23][24]
In November 2021, the company announced compassionate use of brilacidin, for the treatment of extremely
critically-ill patients. Compassionate use cases comprised brilacidin being administered over a longer duration (up to
10 days) than in the phase II COVID-19 trial (3 and 5 day dosing), with some patients also receiving higher and more
frequent dosing (two doses every 24 hours) [25]
In January 2021, the US FDA granted fast track designation for brilacidin for the treatment for COVID-19
infections[26].
In September 2020 Innovation Pharmaceuticals released preclinical data for brilacidin, , in combination with
remdesivir [see AdisInsight drug profile 800043325(Remdesivir Gilead Sciences)] in a human lung cell line for
COVID-2019 infections. Brilacidin exhibited an inhibitory effect on SARS-CoV-2, as well as different types of
alphaviruses, in cell culture[27].
In March 2021, Innovation Pharmaceuticals released preclinical data for brilacidin from cell culture assays in
COVID-2019 infections[28].
In August 2020, Innovation Pharmaceuticals released preclinical data for brilacidin from antiviral assays in
COVID-2019 infections[29][30].
In July 2020, Innovation Pharmaceuticals released data evaluating from the ongoing laboratory testing being
conducted at a U.S. Regional Biocontainment Laboratory (RBL). Based on the results the company is considering
conducting in vitro testing combining Brilacidin with Remdesivir[31].
In August 2021, Innovation Pharmaceuticals reported that, in preclinical studies, brilacidin demonstrated potential
activity against endemic H-CoV strains (OC43, 229E, NL63) and inhibited different H-CoV strains which showed
that brilacidin as a pan-coronavirus agent[32].
As of July 2020, ongoing laboratory testing conducted at a US Regional Biocontainment Laboratory (RBL), and at a
Public Health Research Institute, supported Brilacidin’s antiviral ability to safely inhibit SARS-CoV-2 in both human
and animal cell lines. The neutralisation experiments (with a pseudotyped virus), binding in vitro experiments (using
isolated SARS-CoV-2 Spike protein) and studies in lung epithelial cell line conducted at the RBL supported antiviral
activity of brilacidin against SARS-CoV-2. In June 2020, Innovation Pharmaceuticals released the results from the
preclinical studies of brilacidin conducted at a US RBL in human lung cell lines for the treatment of COVID-2019
infections. The company also intends to seeking FDA guidance for a planned COVID-19 clinical study. Earlier in
May 2020, Innovation Pharmaceuticals announced that the Lab testing supported Brilacidin’s antiviral activity in
directly inhibiting SARS-CoV-2 in cellular assays, with a molecular screening study of 11,552 compounds also
supporting it as a promising novel coronavirus treatment. Additional pre-clinical and clinical data support the drug's
potential to inhibit the production of IL-6, IL-1b, TNF-a and other pro-inflammatory cytokines and chemokines,
which have been identified as central drivers in the worsening prognoses of COVID-19 patients[33][34][35]. As of
July 2020, manufacturing preparation for COVID-19 infections are underway[36][37].
Innovation Pharmaceuticals in November 2020, reported data from in vitro studies, whereby brilacidin demonstrated
similar inhibition againsut two strains of SARS-CoV-2. The data indicated that brilacidin may not be susceptible to
development of resistance due to mutaions in SARS-CoV-2[19]. In May 2020, Innovation Pharmaceuticals released
preclinical data for brilacidin from antiviral assays in COVID-2019 infections. Brilacidin showed broad spectrum
antiviral activity and potent and consistent inhibition in vitro against coronaviruses, alphaviruses and bunyaviruses. In
July 2021, the company presented the in vitro antiviral data at the American Society of Virology’s 40th Annual
Meeting (ASV-2021)[38][14][39][35].
As of March 2020, Brilacidin’s potential inhibitory activity as a small molecule drug against COVID-2019 infections
was being evaluated at one of 12 Regional Biocontainment Labs (RBL) in the US. company released the data from
the research, demonstrating direct inhibition of SARS-CoV-2. In April 2020, Innovation Pharmaceuticals announced
the brilacidin as a promising and unique (a 3 in 1 combination; antiviral, immune/anti-inflammatory, and
antimicrobial) anti-COVID-19 therapeutic candidate[2][40][41][42].
Coronavirus infections
In January 2021, Innovation Pharmaceuticals announced that brilacidin in preclinical testing inhibited the Washington
and Italian strains of the coronavirus[43]. In November 2020, Innovation Pharmaceuticals reported that brilacidin
showed potent in vitro inhibition of multiple strains of endemic human coronaviruses (H-CoVs). The company also
intends to conduct additional in vitro and in vivo studies on multiple coronaviruses with the aim of developing
brilacidin as pan-coronavirus therapeutic[44].
Inflammatory bowel disease
In February 2020, Innovation Pharmaceuticals completed the phase I trial and announced that the trial met its primary
endpoints. The randomised trial, initiated in January 2020 and was designed to assess the safety, tolerability and
pharmacokinetics of oral formulation of brilacidin in healthy volunteers (NCT04240223; BC250;
EudraCT2019-003367-22). The single-center enrolled 9 healthy volunteers in the UK[45][46].
In January 2019, Innovation Pharmaceuticals released favourable pharmacokinetic data from a simulated gastric fluid
model, testing the stability of an oral formulation of brilacidin, for the treatment of inflammatory bowel disease[47].
Skin and soft tissue infections
Following a positive end-of-phase II meeting with the US FDA in July 2015, Innovation Pharmaceuticals plans to
advance brilacidin to phase III development in patients with ABSSSIs. The trial is expected to begin in 2017. The
trial initiation is dependent on reaching SPA agreement with the FDA[48][49]. As required by the FDA, the
programme will consist of two phase III studies, the first of which will include an interim analysis for early
assessment of efficacy and safety. In September 2015, Cellceutix submitted a Paediatric Study Plan to the US FDA
with the aim of expanding the use of brilacidin to children. Lab testing of brilacidin which is to be used in the
upcoming phase III trials was completed in December 2015. In February 2016, the company announced that it has
submitted a Special Protocol Assessment (SPA) request, including information requested by the US FDA to initiate
the planned phase III clinical trials of Brilacidin, for the treatment of ABSSSI caused by Gram-positive bacteria,
including methicillin-resistant (MRSA). The SPA request includes details Staphylococcus aureus of intravenous
vancomycin with an option to switch to oral linezolid after three days of therapy as a choice of comparator for the
phase III programme[50][51][52][53][54][55].
In August 2014, Cellceutix completed a randomised, double-blind phase IIb trial designed to assess the safety and
efficacy of three dosing regimens of brilacidin, compared with daptomycin, in patients with ABSSSIs caused by
Staphylococcus aureus (including MRSA) and Streptococcus pyogenes (NCT02052388). The trial was initiated in
February 2014 and enrolled 215 patients in the US. The trial demonstrated that a single intravenous dose of brilacidin
delivered comparable outcomes to a seven-day dosing regimen of the FDA-approved drug, daptomycin, in patients
with ABSSSIs. In October 2014, the company reported top-line data from the trial and additional data from the
microbiological intent-to-treat population was released in December 2014. In April 2015, the company reported that it
has gathered microbiological data from bacterial pathogens isolated in the trial along with pharmacokinetic and
pharmacodynamics data and also in-depth evaluated the safety profile of brilacidin against that of daptomycin in this
patient population. The data will determine the appropriate dose of brilacidin for a planned phase III
registration-enabling trial [56][57][58][59][60][61][62][63][64][65][66][67][68][69][70][71][72].
In September 2015, Cellceutix had developed a population pharmacokinetic model for brilacidin using data from
three phase I and two phase II trials in patients with ABSSSI. The model was developed to describe the time-course
of brilacidin in plasma and to identify predictor's of pharmacokinetics[73].
Brilacidin was associated with high and sustained clinical response rates across all dose groups in a phase IIa trial in
patients with ABSSSIs caused by either meticillin-susceptible (MSSA) or meticillin-resistant (MRSA)
Staphylococcus aureus (PMX63-203; NCT01211470). Patients were randomised to one of three dosing regimens of
brilacidin or daptomycin, and were assessed at 48 and 72 hours for clinical and microbiologic response. Brilacidin
was administered once-daily for five days followed by two days of placebo. Daptomycin was administered once-daily
for seven days. Patients were re-evaluated at day 10 to 15 for test of cure, and again for safety at four weeks. In
September 2011, PolyMedix received clearance from European regulatory agencies to conduct the trial in Europe.
Enrolment of 215 patients in Canada, Ukraine, Russia and other European sites was completed in January
2012[74][75][76][77][78].
PolyMedix completed a phase I trial (PMX63-103) of brilacidin in healthy volunteers in the US in February 2011.
The randomised, double-blind study evaluated the tolerability and pharmacokinetics of intravenous brilacidin, given
with an initial loading dose followed by once-daily dosing at its highest anticipated therapeutic dose for up to 14 days,
in 16 subjects[79][80][81]. Volunteers in this study reported experiencing temporary paraesthesia of the face and
fingers during brilacidin, similar to those seen in previous phase I studies. To determine the mechanism of the effect,
PolyMedix conducted additional in vitro and in vivo studies, and based on these data, PolyMedix believes that the
paraesthesia may be associated with temporary interactions with specific potassium, sodium or acid sensing ion
channels located on sensory nerve fibres[82][83]. After completion of the phase I trial, PolyMedix intended to hold
discussions with the FDA concerning further development of the drug in the US[84].
In March 2010, PolyMedix released final results for its phase Ib trial of brilacidin that assessed the safety of repeated
dosing[85]. The study was designed to mimic the expected clinical dosing regimen. Healthy volunteers received
brilacidin or placebo twice a day for five days at doses ranging from 0.1-0.6 mg/kg every 12h, 24h or 48h, for a total
of 5 to 10 doses. Results showed that the optimal dose for phase II investigation was found to be 0.3 mg/kg/day (0.3
mg/kg every 12 hours or 0.6 mg/kg every 24 hours)[86][87][88][89][90][91].
In May 2008, PolyMedix received a notice of no objection from Health Canada to begin phase I trials for brilacidin.
The first phase I trial was subsequently initiated in August 2008 and assessed the safety of brilacidin in a
dose-escalation study in approximately 30-50 healthy volunteers who received a single IV dose of brilacidin [92]. The
subjects were grouped into different cohorts with different dosage levels which allowed for the study of the effects of
increased dosages. Positive results from this phase Ia trial were presented in December 2008 [93][94].
In December 2014, the US FDA granted the qualified infectious disease product (QIDP) designation to brilacidin for
the treatment of ABSSSI[95]. Innovation Pharmaceuticals also intends to file for fast track designation in this
indication, in the US. The company believes it may be possible to market brilacidin before the planned phase III trial
has been completed. Brilacidin is eligible for additional FDA incentives in the approval and marketing path, including
Fast Track designation and Priority Review for development and a potential five-year extension of market exclusivity
under the Generating Antibiotics Incentives Now (GAIN) Act[96][97][64].
Stomatitis (oral mucositis)
In November 2019, the US FDA waived initial Pediatric Study Plan requirement for brilacidin, for the prevention of
severe oral mucositis in head and neck cancer patients receiving chemoradiation, in pediatric populations. Innovation
Pharmaceuticals will focus on development of brilacidin in for the treatment of oral mucositis in adult patients[98].
In December 2018, Innovation Pharmaceuticals announced that the US FDA completed an End-of-Phase 2 meeting
concerning the continuing development of Brilacidin oral rinse to decrease the incidence of severe oral mucositis
(SOM) in head and neck cancer (HNC) patients receiving chemoradiation. In October 2018, the company had
reported that the US FDA had granted an End-of-Phase 2 meeting for its clinical development programme of
brilacidin oral rinse[99][100].
In March 2019, Innovation Pharmaceuticals reported that the documentation for the European Medicines Agency
(EMA) March 15, 2019 submission cycle requesting scientific advice to advance brilacidin oral rinse in a phase III
programme for the prevention of severe oral mucositis in head and neck cancer patients receiving chemoradiation has
been completed. EMA granted a meeting with Innovation Pharmaceutical's subsidiary, IPIX Pharma, in April
2019[101][102].
In November 2015, Cellceutix reported that the US FDA had granted Fast Track Designation to the oral rinse
formulation of brilacidin for the treatment of oral mucositis. Additionally, in October 2017, Innovation
Pharmaceuticals reported that it intends to apply for FDA Breakthrough Therapy Designation, and follow a similar
expedited path in Europe, subject to condition that the CTIX-BRI205 phase II trial of brilacidin [see below] yields
comparable safety and efficacy results, to those observed at interim[103][104][105].
A phase II trial of brilacidin met its primary and secondary endpoints, including reduced incidence of severe
stomatitis experienced by patients during radiation therapy, in December 2017, and subsequently the trial was
completed (CTIX-BRI205; NCT02324335). The trial evaluated the efficacy and tolerability of brilacidin (45 mg/15
ml oral rinse), as compared with a placebo rinse, for the prevention of stomatitis in patients with head and neck cancer
undergoing chemoradiation. The primary endpoint was assessed by sequential WHO oral mucositis score at multiple
time-points. Innovation had completed the trial in November 2017. Positive preliminary interim efficacy,
pharmacokinetics and adverse events data from the trial were released by Cellceutix, in March 2017. Updated results
from the trial were reported in January 2018, April 2018 and May 2018. The trial met its primary and secondary
endpoints[106][107]. The randomised 1:1, parallel, double-blind trial was initiated in August 2014 and enrolled 61
patients in the US[108][109][110][104][111][112][113][48][114][115][116][117].
In October 2014, the IND for a phase II trial of brilacidin (brilacidin-OM) for the treatment of oral mucositis became
effective, and selected a trial site in the US[60]. Cellceutix submitted IND application with the US FDA in September
2014[61]. The company received the final IND-enabling toxicology report for brilacidin in this indication in August
2014[118]. In December 2014, Cellceutix received approval from the Institutional Review Board for initiation of the
study for prevention of oral mucositis in patients undergoing chemoradiation for treatment of head and neck
cancer[57][7][119][117].
In preclinical trials, brilacidin demonstrated immunomodulatory, antibacterial, anti-biofilm and anti-inflammatory
properties, which support the phase II trial of brilacidin for prevention of oral mucositis[56][120].
Brilacidin-OM reduced the occurrence of severe ulcerative oral mucositis by more than 94% as compared with
placebo in an animal model[121]. Brilacidin demonstrated the ability to significantly reduce ulcerations in an animal
model of radiation-induced stomatitis. The agent was administered as a preventive oral rinse thrice daily for 20 days.
No adverse events were reported[122]. Brilacidin has also shown positive results in a 28-day acute radiation model,
and a 35-day fractionated radiation model[123]. PolyMedix was working toward filing an IND with the US FDA to
initiate a clinical trial in early 2013 in patients with stomatitis. Following its acquisition of PolyMedix, Cellceutix
announced that it will prioritise completion of the IND filing to pursue development in the oral mucositis
indication[97][124].
Cellceutix has filed an application with the US FDA in December 2013 requesting orphan drug status for brilacidin in
this indication[125].
Ulcerative proctitis/colitis
In January 2020, Innovation Pharmaceuticals initiated a phase I trial to assess the safety, tolerability, and
pharmacokinetics of delayed release tablets of brilacidin in healthy volunteers. The randomised, double-blind,
placebo-controlled trial intends to enrol approximately nine patients in the UK. In the same month, the company
completed dosing in the trial. After reviewing the safety findings from the first cohort, the Dose Escalation
Committee (DCE) recommended to progress dosing to the second cohort. In December 2019, the United Kingdom’s
Medicines and Healthcare products Regulatory Agency granted approval to Innovation Pharmaceuticals to conduct a
phase I trial for delayed release tablets of brilacidin in healthy volunteers, for the development in ulcerative
colitis[126][127][128][129][46][130].
In June 2017, Cellceutix completed a phase IIb proof-of-concept trial evaluating efficacy, pharmacokinetics, safety
and tolerability of brilacidin, as a retention enema at 50 mg, 100 mg, and 200 mg once daily for six weeks, in patients
with ulcerative colitis (ulcerative proctitis/ulcerative proctosigmoiditis) (CTIX-BRI-206)[131]. The open label, dose
escalation, trial initiated in June 2016 enrolled 17 patients, in Europe. The primary endpoint was to assess the
frequency of clinical remission with brilacidin administered per rectum by enema, in patients with active ulcerative
proctitis after 6 weeks of treatment. In July 2016, the first patient was enrolled. In October 2016 and November 2016,
the company reported pharmacokinetics and efficacy data of patients treated in the first cohort of 50 mg brilacidin,
demonstrating a well-tolerated drug safety profile, devoid of measurable systemic absorption. In December 2016, the
company initiated the second cohort of brilacidin 100mg once daily, which was administered as a retention enema. In
January 2017, enrolment in the second cohort was completed and brilicidin was well tolerated. In February 2017,
enrolment was initiated in the third cohort of the trial. Patients received 200mg of brilacidin in this cohort. In January
2017, the company released phase II data showing that brilacidin was well-tolerated with no severe adverse events
reported and no detection of measurable systemic absorption. Preliminary review in patients in the first cohort
showed meaningful improvements for 5 of the 6 patients, including noticeable reductions in ulceration and
bleeding[132][133][134][135][136][56][49][137][138][139][48][140][11][141]. In March 2017, the company
released additional updated results for the first two cohorts from this study. In May 2017, Cellceutix completed
ulcerative proctitis patient enrolment in the third and the last cohort[142][143].
In November 2014, Innovation Pharmaceuticals announced that IND-enabling studies of brilacidin in ulcerative
colitis are underways[7][141].
Innovation Pharmaceuticals plans to conduct gastroenterological studies of brilacidin as foam and tablet formulations
[136].
In September 2019, Innovation Pharmaceuticals announced that non-clinical studies for oral formulation for
Brilacidin met the in vitro specifications for selective delivery to the colon[144].
Cellceutix reported in September 2013 of its plans to assess the scientific data showing the potential of brilacidin for
the treatment of inflammatory bowel diseases[97]. Since then, the company conducted preclinical studies evaluating
immunomodulatory properties of brilacidin in animal models of Crohn's disease, ulcerative colitis and inflammatory
bowel disease[60].
Other indications
In October 2021, Innovation Pharmaceuticals announced that preclinical studies are underway in Marburg virus
disease, Nipah virus infection, West Nile virus infection, Zika virus infection in the US[6].
In March 2020, Innovation Pharmaceuticals announced that the testing of brilacidin as a novel experimental treatment
against the latest coronavirus is scheduled to commence in third week of March 2020. Innovation Pharmaceuticals
will research its drug candidate, brilacidin with US based Regional Biocontainment Lab (RBL) to evaluate its
potential antiviral and anti-inflammatory properties for novel coronavirus treatment. The company has submitted
preliminary summary of brilacidin's potential as a novel coronavirus treatment to the Biomedical Advanced Research
and Development Authority (BARDA), which is dedicated to rapidly identifying and funding medical
countermeasures to the COVID-19 outbreak[145][146]. Innovation Pharmaceuticals intends to develop brilacidin, for
the treatment of coronavirus infections designated as COVID-2019 infections and potentially Middle East respiratory
syndrome coronavirus (MERS-CoV) and severe acute respiratory syndrome coronavirus (SARS-CoV)[147][148].
Innovation Pharmaceuticals plans to initiate clinical trials of brilacidin for the treatment of atopic dermatitis, acne and
hidradenitis suppurativa[111][135][136][149]. In January 2018, Innovation Pharmaceuticals reported that the
company was in discussion with a leading drug formulator to develop topical formulation/formulations of brilacidin
for these three dermatology indications[150].
Preclinical studies demonstrated good minimum inhibitory concentration values when brilacidin was tested against
species, expressed in acne, as compared with other antibiotics, such as erythromycin, Propionibacterium clindamycin,
minocycline, doxycycline and metronidazole[151].
Preclinical trials of an ophthalmic formulation have been conducted by Cellceutix for various ophthalmic infections,
including keratitis and conjunctivitis. The studies showed promising pharmacokinetic outcomes and antimicrobial
activity[152]. The University of Pittsburgh conducted preclinical safety and tolerability studies and Iris Pharma
investigated the pharmacokinetic profile of brilacidin for use in ocular infections. Dr Reddy's Laboratories are
involved in the formulation development of brilacidin-ocular.
In December 2015, Innovation Pharmaceuticals plans to start a retinoblastoma program including formulation and
toxicity studies, additional ototoxicity studies with brilacidin in different concentrations and proceed with studies in
gram- negative and anti-fungal applications for brilacidin. The programme is intended to be initiated by
mid-2016[49].
In August 2014, Cellceutix reported that it is developing its new room temperature-stable formulation of brilacidin for
the treatment of infected diabetic foot ulcers. Innovation Pharmaceuticals intends to conduct clinical trials for infected
diabetic wounds [10]. In May 2014, the company released preclinical data demonstrating wound healing properties of
brilacidin in a diabetic rat model. Innovation Pharmaceuticals is planning to conduct additional preclinical trials in
infected diabetic wound models[153].
Innovation Pharmaceuticals is also conducting preclinical studies of brilacidin for otitis media and otitis externa[154].
The company will develop its new room temperature-stable formulation for the treatment of otitis media[10]. Dr
Reddy's Laboratories are involved in the formulation development of brilacidin-otic.
PolyMedix suspended the preclinical development of brilacidin as topical (ophthalmic infections) and oral (intestinal
infections) applications pending further allocation of resources, according to its Form 10-K (filed 12 March 2010).
In June 2015, Cellceutix reported that it is in the process of completing formulation work for brilacidin in treating
hidradenitis suppurativa[114]. The company had previously planned a pre-IND meeting with the US FDA for a phase
II trial for this indication but decided it will only advance this programme after review of preliminary data from the
oral mucositis trial.
Financing information
In June 2020, Innovation Pharmaceuticals in collaboration with the US Regional Biocontainment Laboratory (RBL)
submitted a federal grant application proposing to evaluate brilacidin’s potential as a pan-coronavirus therapeutic,
with possible extension into other viruses based on the preclinical results in COVID-2019 infections (see above
)[34][155].
In October 2018, Innovation Pharmaceuticals secured financing for up to $US10 million, which includes an initial net
placement of approximately $US2.2 million over the course of the first 30 days. The company intends to utilise these
funds for the continued advancement of brilacidin for oral mucositis, kevetrin [see Adis Insight Drug profile
800028294(Thioureidobutyronitrile Innovation Pharmaceuticals)] for ovarian cancer and prurisol [see Adis Insight
Drug profile 800028312(Abacavir Innovation Pharmaceuticals)] for psoriasis[156].
In April 2015, Cellceutix entered into a common stock purchase agreement with Aspire Capital Fund. Aspire agreed
to purchase upto $US30 million of the company's common stock over 3 years. The proceeds will be used to support
brilacidin development and development of other pipeline candidates. Previously, Aspire Capital had completed two
similar transactions with the company totalling $US30 million[157].
In March 2013, PolyMedix announced a proposed public offering of common stock, which was expected to raise
approximately $US25 million. Potential proceeds were to be used to conduct clinical trials of brilacidin and general
corporate uses[158].
In November 2010, PolyMedix was awarded two grants totalling $US488 958 under the Qualifying Therapeutic
Discovery Project (QTDP) programme, created as part of the Patient Protection and Affordable Care Act of 2010.
The maximum grant amount was awarded for two of PolyMedix's programmes, including the development of
brilacidin[159].
PolyMedix developed brilacidin as a topical rinse for the treatment of stomatitis and received a Phase I grant from the
NCI to further explore the potential of this compound in addressing this unmet medical need[124][160].
In March 2010, PolyMedix closed a debt financing for gross proceeds of $US10 million, and in November 2009, the
company closed an equity financing for gross proceeds of $US20.7 million. This provided significant additional
financing to fund some of the continued clinical development of brilacidin and delparantag.
PolyMedix secured a $US14 million credit facility with Hercules Technology II, L.P. in April 2010. PolyMedix
intended to use proceeds from the facility to fund certain phase III enabling activities for brilacidin and delparantag,
including manufacturing and toxicology studies[161].
Patent Information
In February 2019, Innovation Pharmaceuticals reported that the USPTO had granted patent number 10 206 894,
which covers methods for treating and/or preventing mucositis with one or more compounds, or pharmaceutically
acceptable salts[162].
Innovation Pharmaceuticals reported that the USPTO granted the “Issue Notification” of a new patent (projected US
patent number 10 166 232) that covers brilacidin in the form of a pharmaceutical composition containing water and
Tris-buffered saline. The patent also covers Brilacidin in combination with additional therapeutic agents, including an
antibiotic, an anti-inflammatory agent, an anesthetic agent, an anti-allergic agent, an acetylcholine blocking agent, an
adrenergic agonist, a beta-adrenergic blocking agent, an anti-glaucoma agent and an anti-hypertensive agent. This
patent builds on the “Notice of Allowance” covering oral, buccal and sublingual pharmaceutical compositions of
brilacidin[163].
In November 2018, the USPTO issued a 'Notice of Allowance' to Innovation Pharmaceuticals, covering oral, buccal,
and sublingual pharmaceutical compositions of brilacidin, including liquid compositions, such as rinses. Earlier, US
patents with patent numbers 8 802 683, 9 155 738, 9 457 027 and 9 795 575 were granted[164].
Innovation Pharmaceuticals, in December 2017, was granted a European patent by the European Patent Office for
brilacidin for the prevention and control of oral mucositis. Similar patents were granted in the US, Asia (Japan,
Taiwan, China), Australia and South Africa, all the patents are valid through 2032. The candidate also has pending
patent applications in Russia and South Korea[165].
In September 2009, the University of Pennsylvania was issued US Patent No. 7,590,517 entitled 'Methods, Systems,
and Computer Program Products for Computational Design of Amphiphilic Polymers,' which provides protection for
the underlying process and implementation of two proprietary computational methodologies, PACE™ (Proteomic
Assisted Computational Engine) and GOLDYN™ (Global Optimization of Long-time Dynamics force field). The
two methodologies were used by PolyMedix in its development of defensin mimetic antibiotic compounds, including
brilacidin[166].
PolyMedix was issued the US Patent No. 7,173,102 entitled 'Facially Amphiphilic Polymers as Anti-Infective Agents'
in February 2007. The patent claims compositions of matter for facially amphiphilic polymers and oligomers. Also
claimed are antimicrobial material compositions, methods of killing micro-organisms and processes of producing
antimicrobial surfaces[167].
Drug Properties & Chemical Synopsis
Route of administration IV, Ophthalmic, Otic, PO, Rectal, Topical
Formulation Controlled release, Enema, Infusion, Liquid, unspecified
Class Amides, Anti-infectives, Anti-inflammatories, Antiacnes, Antibacterials, Antivirals, Foot disorder
therapies, Guanidines, Peptidomimetics, Pyrimidines, Pyrrolidines, Skin disorder therapies, Small
molecules
Target Cell membrane structure; Type 4 cyclic nucleotide phosphodiesterase; Virus internalisation
Mechanism of Action Cell membrane permeability enhancers; Cell membrane structure modulators;
Immunomodulators; Type 4 cyclic nucleotide phosphodiesterase inhibitors; Virus internalisation
inhibitors
WHO ATC code
A01A (Stomatological Preparations)
A07E (Intestinal Antiinflammatory Agents)
D03 (Preparations for Treatment of Wounds and Ulcers)
D10 (Anti-Acne Preparations)
D11 (Other Dermatological Preparations)
J01X (Other Antibacterials)
J05A-X (Other antivirals)
S02A (Antiinfectives)
EPhMRA code
A1 (Stomatologicals, Mouth Preparations, Medicinal Dentifrices etc)
A7E (Intestinal Anti-Inflammatory Agents)
D10 (Anti-Acne Preparations)
D11 (Other Dermatological Preparations)
D3 (Wound Healing Agents)
J1X (Other Antibacterials)
J1X1 (Glycopeptide antibacterials)
J5 (Antivirals for Systemic Use)
S2A (Otic Anti-Infectives)
Chemical name N4,N6-bis(3-(5-guanidinopentanamido)-2-((R
)-pyrrolidin-3-yloxy)-5-(trifluoromethyl)phenyl)pyrimidine-4,6-dicarboxamide tetrahydrochloride
Molecular formula C40 H54 Cl4 F6 N14 O6
SMILES
C1=C(C=C(C(=C1NC(=O)CCCCNC(=N)N)OC1CCNC1)NC(=O)C1=CC(=NC=N1)C(=O)NC1=CC(=CC(=C1OC1CCNC1)Chemical Structure
CAS Registry Number 1224095-98-0
Related CAS Registry Number 1224095-99-1(tetrahydrochloride)
Biomarkers Sourced From Trials
Indication Biomarker Function Biomarker Name Number of Trials
abscess Eligibility Criteria
T-cell surface antigen CD4
C-reactive protein (CRP)
1
1
COVID-19 respiratory infection Outcome Measure
Tumor necrosis factor alpha
(TNF-alpha)
Lactate dehydrogenase (LDH)
Interleukin-6 (IL-6)
Interleukin-18 (IL-18)
Interleukin-10 (IL-10)
Ferritin
D-dimer
Cardiac Troponin I
C-reactive protein (CRP)
1
1
1
1
1
1
1
1
1
methicillin-resistant Staphylococcus
aureus infections
Eligibility Criteria
T-cell surface antigen CD4
C-reactive protein (CRP)
2
1
post-traumatic infections Eligibility Criteria
T-cell surface antigen CD4
C-reactive protein (CRP)
1
1
postoperative infections Eligibility Criteria
T-cell surface antigen CD4
C-reactive protein (CRP)
1
1
skin and soft tissue infections Eligibility Criteria
T-cell surface antigen CD4
C-reactive protein (CRP)
2
1
staphylococcal infections Eligibility Criteria
T-cell surface antigen CD4
C-reactive protein (CRP)
2
1
streptococcal infections Eligibility Criteria
T-cell surface antigen CD4
C-reactive protein (CRP)
1
1
wound infections Eligibility Criteria
T-cell surface antigen CD4
C-reactive protein (CRP)
1
1
Biomarker
Drug Name Biomarker Name Biomarker Function
Brilacidin - Alfasigma/Innovation Pharmaceuticals C-reactive protein (CRP) Eligibility Criteria, Outcome Measure
Cardiac Troponin I Outcome Measure
D-dimer Outcome Measure
Ferritin Outcome Measure
Interleukin-10 (IL-10) Outcome Measure
Interleukin-18 (IL-18) Outcome Measure
Interleukin-6 (IL-6) Outcome Measure
Lactate dehydrogenase (LDH) Outcome Measure
T-cell surface antigen CD4 Eligibility Criteria
Tumor necrosis factor alpha (TNF-alpha) Outcome Measure
For more detail, check out BiomarkerBase: the leading source of information about biomarkers used in drug
development and diagnostic tests, tracking a comprehensive list of biomarker uses worldwide by over 800 companies
Trial Landscape
Indication Phase 0 Phase I Phase II Phase III Phase IV
COVID-19 respiratory
infection
- - 1 - -
Staphylococcal
infections
- 3 2 1 -
Acne - 2 - - -
Ulcerative proctitis - 1 2 - -
Inflammatory bowel
diseases
- 2 3 - -
Crohn's disease - 1 - - -
Streptococcal
infections
- - 1 1 -
Wound infections - - 1 - -
Abscess - - 1 - -
Methicillin-resistant
Staphylococcus aureus
infections
- - 2 1 -
Postoperative
infections
- - 1 - -
Atopic dermatitis - 2 - - -
Post-traumatic
infections
- - 1 - -
Skin and soft tissue
infections
- 4 2 2 -
Stomatitis - 1 1 1 -
Ulcerative colitis - 2 3 - -
Ulcerative
proctosigmoiditis
- - 2 - -
Hidradenitis
suppurativa
- 2 - - -
Development Status
Summary Table
Indication Qualifier
Patient
Segment
Phase Countries
Route /
Formulation
Developers Event Date
Acne - - Preclinical USA
Topical /
unspecified
Innovation
Pharmaceuticals
26 Oct 2016
Alphavirus
infections
- - Preclinical USA
unspecified /
unspecified
Innovation
Pharmaceuticals
27 May 2021
Atopic
dermatitis
Eczema - Preclinical USA
Topical /
unspecified
Innovation
Pharmaceuticals
01 Nov 2016
Bunyavirus
infections
- - Preclinical USA
unspecified /
unspecified
Innovation
Pharmaceuticals
27 May 2021
COVID 2019
infections
- - Phase II
Russia, USA
(fast track)
IV / unspecified
Innovation
Pharmaceuticals
22 Feb 2021
COVID 2019
infections
- Prevention Preclinical USA IV / unspecified
Innovation
Pharmaceuticals
04 Aug 2020
Coronavirus
infections
- - Preclinical USA
unspecified /
unspecified
Innovation
Pharmaceuticals
30 Nov 2020
Diabetic foot
ulcer
- -
No
development
reported
(Preclinical)
USA
unspecified /
unspecified
Innovation
Pharmaceuticals
28 Aug 2018
Ebola virus
infections
- - Preclinical USA
unspecified /
unspecified
Innovation
Pharmaceuticals
25 Oct 2021
Hidradenitis
suppurativa
- - Preclinical USA
Topical /
unspecified
Innovation
Pharmaceuticals
01 Nov 2016
Inflammatory
bowel diseases
- In volunteers Phase I
United
Kingdom
PO / Controlled
release
Innovation
Pharmaceuticals
06 Feb 2020
Inflammatory
bowel diseases
- - Preclinical USA
PO / Controlled
release
Innovation
Pharmaceuticals
14 Jan 2019
Intestinal
infections
- -
Discontinued
(Preclinical)
USA
PO /
unspecified
Innovation
Pharmaceuticals
08 Jan 2018
Marburg virus
disease
- - Preclinical USA
unspecified /
unspecified
Innovation
Pharmaceuticals
25 Oct 2021
Nipah virus
infections
- - Preclinical USA
unspecified /
unspecified
Innovation
Pharmaceuticals
25 Oct 2021
Ophthalmic
infections
- -
Discontinued
(Preclinical)
USA
Ophthalmic /
unspecified
Innovation
Pharmaceuticals
08 Jan 2018
Otitis - -
No
development
reported
(Preclinical)
USA
Otic /
unspecified
Innovation
Pharmaceuticals
28 Feb 2018
Skin and soft
tissue
infections
Acute bacterial
skin and skin
structure
infections due
to
Staphylococcus
aureus Acute
bacterial skin
and skin
structure
infections due
to
Staphylococcus
aureus
(including
- Phase II
Canada, Russia,
USA, Ukraine
IV / Infusion
Innovation
Pharmaceuticals
18 Feb 2014
MRSA) and
Streptococcus
pyogenes
Stomatitis
In patients with
head and neck
cancer
undergoing
chemoradiation
Prevention Phase II
USA (fast
track)
Topical /
Liquid
Innovation
Pharmaceuticals
14 Aug 2014
Ulcerative
colitis
- -
Discontinued
(Preclinical)
USA
Topical /
unspecified
Innovation
Pharmaceuticals
08 Jan 2018
Ulcerative
proctitis
- - Phase II USA Rectal / Enema
Innovation
Pharmaceuticals
15 Jun 2016
Ulcerative
proctitis
- In volunteers Phase I USA
PO / Controlled
release
Innovation
Pharmaceuticals
17 Jan 2020
West Nile virus
infections
- - Preclinical USA
unspecified /
unspecified
Innovation
Pharmaceuticals
25 Oct 2021
Wounds Non-infected -
No
development
reported
(Preclinical)
USA
unspecified /
unspecified
Innovation
Pharmaceuticals
28 Jun 2018
Zika virus
infection
- - Preclinical USA
unspecified /
unspecified
Innovation
Pharmaceuticals
25 Oct 2021
Priority Development Status
Type Region Indication
Fast Track USA COVID 2019 infections; Stomatitis
QIPD USA Skin and soft tissue infections
Commercial Information
Involved Organisations
Organisation Involvement Countries
PolyMedix Originator USA
Innovation Pharmaceuticals Owner USA
Alfasigma Licensee World
University of Pennsylvania Technology Provider USA
Bio-Images Drug Delivery Collaborator United-Kingdom
Dr Reddys Laboratories Collaborator India
Licensing Availability
Licensing Organisation Available Indication Available Phase Region Date
Innovation Pharmaceuticals COVID 2019 infections Unspecified - 20 Apr 2020
Scientific Summary
Adverse Events Frequent: Paraesthesia
Occasional: Blood platelet disorders; Hypertension; Numbness
Pharmacokinetics
Phase II:
Interim results from a phase II study in four patients with ulcerative proctitis, treated with brilacidin at the lowest
dose (50 mg), showed that drug concentrations in plasma, across all time points, were below the lower limit of
quantification (i.e., <100 ng/mL), which is consistent with very limited systemic exposure from administration per
rectum by enema[149][139]. Updated interim results from the phase II study in ulcerative proctitis demonstrated that
drug concentrations in plasma continued to show limited systemic absorption of brilacidin, with all values registering
less than 100 ng/mL for all six patients in Cohort A and averaging approximately 215 ng/mL maximum
concentrations across the six patients in Cohort B[132][143][141].
Stomatitis
In a preliminary interim analysis of a phase II trial, all concentrations of brilacidin were below the lower limit of
quantification (< 10 ng/mL) in plasma samples from six patients. The randomised, double-blind trial is designed to
evaluate the safety and efficacy of brilacidin oral rinse in preventing and controlling oral mucositis in 60 patients with
head and neck cancer undergoing chemoradiation[113][117].
Clinical
In pooled results for two randomised, placebo-controlled, multiple-dose phase I trials of intravenous brilacidin in a
total of 77 healthy male volunteers, the terminal elimination half life varied between 16.6 and 23 hours.
Pharmacokinetics were dose-dependent[176].
The pharmacokinetic parameters of IV brilacidin were similar between male and female volunteers in a phase I
multiple-dose study[82].
In a phase I clinical study involving 22 healthy volunteers, simple exponential kinetics were observed, with a
distribution and elimination half-life of 1.5 and 15 hours, respectively. Peak plasma levels were consistently found to
be about 15 times the dose, so that 0.18 mg/kg resulted in a mean Cmax of 2.7 µg/mL, and the 0.54 mg/kg dose had a
mean Cmax of 8 µg/mL. Pharmacokinetic modelling with this data suggested that a single daily dose of 0.18 mg/kg
would provide steady-state plasma levels exceeding 2 µg/mL for 12 hours daily and exceeding 1 µg/mL continuously.
The same dose twice daily, or a once-daily dose of 0.4 mg/kg, would provide plasma levels exceeding 2 µg/mL for 16
hours and exceeding 1 µg/mL continuously from the first day of treatment[93].
The mean plasma half-life of intravenous brilacidin was 23 hours, according to results from a phase I trial
(PMX63-103) in 16 healthy volunteers. A loading dose of 1mg/kg was followed by 0.35mg/kg daily on days
2-14[80]. Urinary excretion accounted for <1% of elimination; in males and females, respectively, 0.258 and 0.219mg
of drug was recovered unchanged in urine[81].
Preclinical
efficacy in the neutropenic mouse thigh burden with brilacidin against MRSA and MSSA strains of Staphylococcus
demonstrated to be highly correlated with reaching minimal inhibitory concentration (aureus was MIC) levels of free
compound in plasma. Full efficacy was achieved with MSSA and MRSA when plasma C0 values of free brilacidin
reached MIC levels (0.7 to 1.2 µg/ml, respectively), and AUC values of free brilacidin reached 3 000 to 6 000
h*ng/ml, respectively[179].
At maximally efficacious doses in preclinical infection models, pharmacokinetic parameters at therapeutic doses were
comparable to human subjects at doses more than 0.18 mg/kg[93].
Following a single 2mg/kg intravenous dose of [14C]-brilacidin, 40.17% and 25.47% of radioactivity was found in
faeces of male and female rats, respectively. This indicates that the bile and/or the gut mucosa may be a main route of
elimination. Renal excretion is not a significant elimination pathway[81].
In a study involving a simulated gastric fluid model, brilacidin was minimally degraded across four hours, indicating
that orally formulated brilacidin was not susceptible to rapid breakdown in the stomach. These results suggested the
likelihood of developing an oral formulation of the drug for the effective treatment of inflammatory bowel
disease[47].
Preliminary top-line results demonstrated that no quantifiable brilacidin concentrations in blood at any timepoint
across treatment cohorts and shows containment of Brilacidin within the target location[45][46].
Adverse Events
Skin and soft tissue infections
Top-line data from a phase IIb trial in an intent-to-treat population, demonstrated that three dosing regimens of
brilacidin was safe and generally well tolerated in patients with acute bacterial skin and skin structure infections
(ABSSSI). Six severe adverse events, unrelated to the drug, were reported. Adverse events appeared to be
exposure-related. Aside from mild, transient numbness and tingling (for which no patient discontinued treatment), the
overall adverse event rates were under 10% in each treatment group (low, medium and high doses of brilacidin and
daptomycin). In 3.8% (n = 6/160) of patients treated with brilacidin, transient increases in systolic blood pressure
were observed; of these patients, half (n = 3) were in the high-dose group. Previous interim results also showed a case
of increased platelets in the low dose group. In this double-blind trial, 215 patients were randomised to one of three
dosing regimens of brilacidin (0.4 mg/kg on day 1 then 0.30 mg/kg [low], 0.75 mg/kg on day 1 then 0.35 mg/kg
[medium] or 1.0 mg/kg on day 1 then 0.35 mg/kg [high]) once daily for 5 days followed by placebo for 2 days, or
daptomycin once daily for 7 days. An approximately 25% of 215 patients were recruited into each treatment
arm[74][173][175].
Ulcerative proctitis
Phase II
Interim results from the phase II CTIX-BRI-206 proof-of-concept trial in ulcerative proctitis demonstrated that
brilacidin was safe and well tolerated by patients in both cohorts A and B and all patients maintained stable vital
signs. A total of 16 adverse events in six patients were reported, none of which were related to the study drug. No
serious adverse events were reported[132][143][136][141].
Stomatitis:
Brilacidin 45 mg/15 ml oral rinse, for prevention and control of stomatitis, was generally safe and well-tolerated in a
phase II trial in patients with head and neck cancer undergoing chemoradiation. Safety findings were typical for
patients with this indication and all treated patients reported at least one treatment-emergent adverse event (TEAE).
At least one serious adverse event (SAE) was reported in 13 patients, 8 from the brilacidin group, and 5 from the
placebo group, of the TEAE categorised as SAEs. SAEs were not related to brilacidin treatment. There was no death
because of the SAEs. The randomised 1:1, parallel-group, double-blind trial enrolled 61 patients. The oral rinse of
brilacidin or placebo was self-administered by patients for three times daily across 7 consecutive weeks in the
trial[110][113][117].
Healthy volunteers
Phase I
in pooled results for two randomised, placebo-controlled phase I trials of intravenous brilacidin in a total of 77
healthy male volunteers, the most common adverse events were paraesthesia and increases in blood pressure and
heart rate, all of which were transient and required no treatment. No gastrointestinal or renal effects were observed.
Brilacidin showed an unremarkable safety profile between 0.1 and 0.3mg/kg once-daily dosing. Increasing the
frequency of dosing from once- to twice-daily did not appear to improve the safety profile at comparable dose
levels[176].
The most frequently reported adverse event in a phase I, multiple-dose trial of brilacidin was transient paraesthesias
of the lips, face and fingers. In this randomised, double-blind study, 20 male and female volunteers received a loading
dose (1mg/kg) of intravenous brilacidin followed by daily dosing (0.35mg/kg) for up to 14 days. The paraesthesias
did not worsen over the study period and most cases resolved after withdrawal of brilacidin. Several volunteers were
withdrawn from the study after 9-13 days' treatment due to hypertension and increased heart rate, and one subject
experienced reversible atrial fibrillation. A few cases of transient elevations in liver enzymes were noted but the
changes were not clinically significant[82]. Based on these results, it was concluded that once-daily dosing of
brilacidin for 5 days is an appropriate regimen[80].
Brilacidin was generally well tolerated whether administered every 12h or every 24h in a phase Ib study in healthy
volunteers. In the randomised, placebo-controlled study, the maximum tolerated dose of brilacidin for investigation in
phase II studies was found to be 3.0 mg/kg (0.3 mg/kg every 12 hours or 0.6 mg/kg every 24 hours). No clinically
significant adverse effects at therapeutic dosages were observed[87][89].
In a phase Ib study of brilacidin, a dose-limiting toxicity was found at the higher dosages and consisted of
paraesthesias. These usually beginning in the oral area and extension to the face, scalp, extremities, upper thorax,
and/or perineum, lasting from hours to days. In all cases the effects were temporary and resolved without treatment.
Transient increases in ALT and AST were observed in some subjects at higher doses and in all cases resolved without
treatment after completion of the study. Healthy volunteers (n = 56) were divided into 8 cohorts and received up to 5
doses of either brilacidin or placebo. The doses ranged from 0.1 mg/kg to 0.6 mg/kg per day and were administered as
a single one-hour infusion every 24 or 48 hours. Dosing continued until a threshold was reached where more than one
volunteer in a cohort tolerated fewer than 5 doses. There were minimal clinically relevant adverse events at 0.2 mg/kg
(total dose of 1.0 mg/kg), and there was no early termination of dosing until the 0.4 mg/kg level. At the 0.5 and 0.6
mg/kg doses (up to 2.5 and 3.0 mg/kg total doses, respectively), the syndrome of subjective effects became more
prominent. As also seen in the previous Phase 1a clinical study, there were no objective correlates or clinical
measurements associated with the sensations. Five of ten subjects intended to receive 2.5 mg/kg or more total dose
tolerated that amount. The data confirmed that a total dose of 3.0 mg/kg, given as 5 doses of 0.6 mg/kg once-daily,
was the limiting dosage in this study[90][83].
In a phase I clinical study involving 22 healthy volunteers, brilacidin at doses 0.54 mg/kg and above resulted in
paresthesias, usually beginning in the oral area and extension to the face, scalp, extremities, upper thorax, and/or
perineum. The degrees of extension appeared to correlate with dosage increase, with symptoms lasting from hours to
days. No adverse events were classified as serious or severe; however, mild to moderate symptoms suggested that
dose escalation could be halted to 2.5 mg/kg[93][83].
Animal toxicology
In preclinical studies, brilacidin at 12 and 24 mg/kg/day bid, given as an IV infusion was well-tolerated. Transient
reduction in feed consumption and body weight loss was observed in the high dose group. No other acute
brilacidin-related effects were observed[181].
Studies on peripheral nerve function in rats showed that the effect of brilacidin is of a pharmacological nature,
without neurotoxicity[185].
Preliminary top-line results from the phase I trial demonstrated that the trial met its primary endpoints and brilacidin
delayed release was well tolerated across all treatment cohorts with no serious adverse events. Two volunteers on
brilacidin delayed release and two on placebo experiences atleast one adverse events of mild intensity and not related
to study treatment[45][46].
Pharmacodynamics
Summary
Brilacidin demonstrated efficacy in the mouse subcutaneous abscess (MSCA) and rat granuloma in vivo pouch (RGP)
infection models of Staphylococcus aureus skin infections. In the MSCA model, brilacidin demonstrated log CFU
reductions of 1.3 - 2.3 for IV dosing regimens (both once and twice daily) between 10-20 mg/kg as compared to
untreated controls. In the RGP model, brilacidin effected log CFU reductions in pouch fluid of 1.1-2.5 following
single IV doses of 4-20 mg/kg and up to a 5 log reduction at 10 mg/kg twice daily (within 6 hrs of
administration)[178].
Brilacidin demonstrated robust efficacy against MSSA and MRSA in a mouse thigh burden model, and against
MSSA in a rat thigh burden model and a mouse peritonitis model[181].
Brilacidin demonstrated activity in vitro against the New Delhi metallo-beta-lactamase-1 (NDM-1) drug resistant
strain of Klebsiella pneumonia[177].
In a chinchilla model of otitis media, brilacidin treatment greatly reduced Streptococcus pneumonia bacterial counts,
with no toxic effects[8].
Brilacidin suppressed various pro-inflammatory mediators (such as TNF-, IL-1, IL-8, IL-6, MMP-9, MCP-1).
Preclinical studies showed dose-dependent inhibition of PDE4B2 and PDE3A, in vitro , with brilacidin treatment.
Brilacidin may possess good cell membrane permeability property, based on similar IC50 values against both PDE4
(biochemical) and cytokine release in cell-based assays. Localised clinical administration allowed brilacidin
concentrations that markedly exceed in vitro IC50 values, thus, providing for increased concentrations of cAMP. The
overall effect of Brilacidin’s ability to modulate cAMP levels supports its potential to treat a number of chronic,
autoimmune and inflammatory diseases related to issues of innate immunity, such as inflammatory bowel disease,
atopic dermatitis and others[169].
In an acute radiation model in hamsters (n=10), brilacidin (at the three highest doses) significantly reduced peak
mucositis scores and daily mucositis scores on 9 to 10 of the 10 evaluation days when stomatitis was evident
(p<0.001 vehicle). At the three highest doses, brilacidin reduced the number of animal days vs with ulceration by
90%; from 42% in vehicle-treated group to <5% in the active treatment groups (p<0.001). Brilacidin was dosed as a
topical rinse three times daily, at 0.03, 1.0, 3.0 or 10.0mg/mL for 28 days, following a single dose of radiation to the
buccal cheek pouch (40 Gy). In a fractionated radiation model in hamsters, brilacidin significantly reduced daily
mucositis scores prior to peak stomatitis, and during the remaining treatment period (p<0.001 vs vehicle). Brilacidin
reduced the number of animal days with ulceration by 94%; from 55% in vehicle-treated animals to 3.3% (p<0.001).
Radiation was administered at 7.5 Gy/dose on days 0, 1, 2, 3, 6, 7, 8 and 9, targeting the left buccal pouch mucosa.
Brilacidin 3mg/mL was dosed three times for 35 days[123].
Treatment of non-infected wounds with brilacidin for 5 days decreased the time to wound healing, compared with
untreated controls, in a diabetic rat model. Complete reduction of the wound area was observed in brilacidin-treated
animals[153].
COVID-2019 infections
In preclinical studies conducted in human lung epithelial cell lines, brilacidin exhibited a statistically significant (p <
0.0001) and potent inhibitory effect on SARS-CoV-2 virus, reducing viral load by 95% and by 97%, compared to
control, at two therapeutic concentrations tested. Based on a CC50 value, the drug was also shown to be
non-cytotoxic in the lung cell line. Brilacidin, in an in vitro experiment in human kidney cell line expressing hACE2,
demonstrated an average of 29% inhibition at 0.1ug/ml and 85% inhibition at 100ug/ml. Earlier in vitro results using
VERO cells, reduced the viral titer (load) of SARS-CoV-2 by 75 percent after only 1 hour of preincubation prior to
infection at a concentration of 10µM as compared to vehicle control. An earlier 16-hour post-infection experiment, in
VERO cells, showed Brilacidin exhibited a dose-dependent reduction in SARS-CoV-2 infectious viral titers.In VERO
cells (a monkey kidney cell line), at 16 hours post-infection, treatment with brilacidin demonstrated a dose-dependent
reduction in the SARS-CoV-2 infectious viral titers compared with vehicle-alone control (Dimethyl sulfoxide or
DMSO)[33][40][41][39][35]
In vitro
data showed brilacidin exhibited a similarly potent inhibitory effect against SARS-CoV-2 at an even lower
concentration in the same human lung epithelial cell line using the previously used assay method (RBL assay; which
included brilacidin pre-incubated with virus). Ninety percent inhibition of SARS-CoV-2 at a drug concentration that
was one-half lower than previously tested was achieved with brilacidin. The drug exhibited inhibition at a
concentration that was similar to that of Remdesivir which again reported 50 percent inhibition of the coronavirus.
The lowest concentration of Brilacidin used in the testing to date is well below the clinically-achievable concentration
of the drug. The RBL data also supported Brilacidin showing an ability to inhibit viral entry into cells, a highly
desirable mechanism of action as it is the first step in the infection process enabling viruses to be targeted outside the
cell, whereas remdesivir impacted viral replication only after the host cell has been infected[31].
Preliminary data in COVID-2019 infections showed that brilacidin’s Selectivity Index (SI) of 426 in a human lung
epithelial cell line. Brilacidin’s SI was higher than the SIs of a vast majority of other antiviral drugs being evaluated
as COVID-19 treatments. In an experiment in a human lung epithelial cell line, brilacidin, when directly incubated
with the live (or wild type) virus, was shown to inhibit the virus by 50% at a mid-nanomolar concentration, while
remaining non-cytotoxic to cells at high micromolar concentrations. Additionally, this testing in the human lung cell
line showed Brilacidin’s IC90 value to be in the low micromolar range[30][29].
In preclinical studies conducted in human lung epithelial cell lines, brilacidin in combination with remdesivir showed
a statistically significant and synergistic inhibition of SARS-CoV-2 compared to remdesivir-only treated conditions.
Overall viral load was reduced by 99.85 percent in one combination experiment, with remaining virus dropping to
near undetectable levels. In other newly conducted studies, brilacidin was shown to inhibit SARS-CoV-2 in a human
intestinal epithelial cell line and in primary fibroblast cells obtained from human donors[27].
Results of preclinical studies showed that brilacidin exerts potent inhibitory effects on SARS-CoV-2 in cell culture by
decreasing the viral load in different cell types, including ACE2 positive human lung cells. Importantly, both
Washington strain-nCoV/USA-WA1/2020 and Italy strain-Italy-INMI1 in Calu-3 cells showed similar decrease.
Brilacidin treatment resulted in a dose-dependent decrease in infectious viral titer with a maximum of 53% inhibition
of virus observed. The level of inhibition observed at entry was slightly lower than that observed for cells pre- and
post-treated with brilacidin concomitantly. Brilacidin had an inhibitory effect on SARS-CoV-2, potentially by
disrupting viral integrity and impairing the virion’s ability to complete the viral entry process[28].
Antiviral data from the studies showed brilacidin’s inhibition of SARS-CoV-2 in additional in vitro cell lines
(Caco-2, primary lung fibroblasts), and brilacidin’s inhibition of alphaviruses, Venezuelan Equine Encephalitis Virus,
Eastern Equine Encephalitis Virus and Rift Valley Fever Virus, a bunyavirus[38].
Antimicrobial Activity
Summary
Clinical
In two phase Ib dose-escalation trials, intravenous brilacidin had antibacterial activity against both
meticillin-susceptible and meticillin-resistant strains of Staphylococcus aureus (MSSA and MRSA) in blood samples
taken from healthy male volunteers who had received brilacidin at doses of 0.1 mg/kg or higher. In these randomised
trials, 77 subjects received either placebo or brilacidin at doses ranging from 0.1-0.6 mg/kg/day, administered every
12h, 24h or 48h[87][89]. Bactericidal activity in serum against MSSA and MRSA strains was observed at single
doses of 0.1-0.3 mg/kg[176].
In antimicrobial assays following brilacidin treatment, bacteriostatic and bactericidal activity against
methicilin-sensitive Staphylococcus aureus (S. aureus ) and MRSA strains were achieved at doses at or above 0.2
mg/kg, and largely correlated with those established in normal medium and in experimental animal studies. Healthy
volunteers (n = 56) were divided into eight cohorts and received up to 5 doses of either brilacidin or placebo. The
doses ranged from 0.1 mg/kg to 0.6 mg/kg per day and were administered as a single 1h infusion every 24 or 48h.
Dosing continued until a threshold was reached where more than one volunteer in a cohort tolerated fewer than 5
doses. Antimicrobial assays were performed with blood samples drawn from the study subjects. In these assays, blood
samples were taken from the subjects after they had been dosed with brilacidin. Staphylococcus aureus bacteria was
then added to these blood samples, to determine if the brilacidin in the subjects blood would have antimicrobial
activity[90][185].
Preclinical
Brilacidin demonstrated potent activity against 1000 worldwide strains of Gram-positive staphylococci and
streptococci clinical isolates, including those resistant to linezolid, daptomycin and methicillin. These data were
presented at the 21st Annual European Congress of Clinical Microbiology and Infectious Disease (ECCMID-2012) in
April 2012[174].
Brilacidin demonstrated a low incidence for development of resistance in vitro , and high selectivity for bacteria
versus mammalian cell types. MIC90 values for brilacidin were 1 µg/mL for S. aureus, 0.5 µg/mL for S. epidermidis,
and 1 µg/mL for S. haemolyticus. Brilacidin was bactericidal with a time-kill range between 30 min and 6h. Brilacidin
was highly stable in the presence of plasma and isolated hepatocytes from multiple species[180].
Therapeutic Trials
Top-line data from a phase IIb trial in an intent-to-treat population, demonstrated that three dosing regimens of
brilacidin met the primary endpoint of reduction of at least 20% in area of acute bacterial skin and skin structure
infections (ABSSSI), compared to baseline, for 48-72 hours, post-first-dosing, without the administration of any
rescue antibiotics. The clinical success rate of the three dosing regimens of brilacidin were statistically comparable to
that of daptomycin. Brilacidin produced early, high and consistent clinical response in patients with ABSSSI. Clinical
response rates at days 2-3, 7-8, 10-14 and 28 were 97.5%, 91.4%, 92.3% and 91.5%; 92.5% 94.3% 97.4% 95.7%;
92.5% 91.4% 97.4% 95.7%; and 87.5% 80.0% 97.4% 93.6%; in the brilacidin low, medium and high dose groups,
and the daptomycin group, respectively. The respective 95% confidence intervals around the clinical success rates
were 85-100%, 90-100%, 94-100%, and 87-100%. In addition to the intent-to-treat population, similar positive results
were obtained in the microbiological intent-to-treat population which consisted of patients who had cultures obtained
at the baseline, which were positive for common ABSSSI pathogens. Majority of the cultures grew Staphylococcus
, 40% of which included methicillin-resistant In this double-blind aureus Staphylococcus aureus. trial, 215 patients
were randomised to one of three dosing regimens of brilacidin (0.4 mg/kg on day 1 then 0.30 mg/kg [low], 0.75
mg/kg on day 1 then 0.35 mg/kg [medium] or 1.0 mg/kg on day 1 then 0.35 mg/kg [high]) once daily for 5 days
followed by placebo for 2 days, or daptomycin once daily for 7 days. An approximately 25% of 215 patients were
recruited into each treatment arm[183][74][173][175][72].
Top line results from a phase II trial demonstrated clear reduction in the incidence of severe stomatitis (OM)(WHO
Grade = 3) on treatment with brilacidin 45 mg/15 ml oral rinse as compared with placebo, in patients with head and
neck cancer undergoing chemoradiation. Overall reduction was 17.1% (brilacidin: 42.9%; placebo: 60.0%) in
modified intent to treat (mITT) population and 23.2% (brilacidin: 36.8%; placebo: 60.0%) in per protocol (PP)
population (primary endpoint). The severe OM median duration was 0.0 days for brilacidin in mITT and PP
populations (secondary endpoint). Overall Severe OM median durations for placebo were 3.0 days and 5.5 days for
the mITT and PP populations. Brilacidin-OM successfully prevented severe oral mucositis from occurring, as well as
delayed its onset, in a substantial number of patients compared with placebo, particularly the period from
approximately 28-42 days, after the initiation of treatment. Brilacidin-OM appeared to decrease the initial duration of
severe oral mucositis (time from the initial WHO Grade = 3 to the first WHO Grade = 2 OM assessment). Initial
instance duration median was 33.5% and overall duration median was 35.5% in modified intent to treat (mITT)
population. In mITT population, incidences were reduced by 65% in brilacidin group, when compared with placebo
(brilacidin: 25.0%; placebo: 71.4%; P = 0.0480) in patients receiving higher concentration of cisplatin (80-100 mg/m2
); in per-protocol population, incidences were reduced by 80.3% in brilacidin group, when compared to placebo
(brilacidin: 14.3%; placebo: 72.7%; P = 0.0249). The randomised 1:1, parallel, double-blind trial enrolled 61 patients.
The oral rinse of brilacidin or placebo was self-administered by patients for three times daily across 7 consecutive
weeks in the trial[108][110][106][107][113][117].
Updated results from the first two cohorts from the phase II CTIX-BRI-206 trial demonstrated that a clinically
beneficial response was observed in all patients, as measured by the Modified Mayo Disease Activity Index
(MMDAI). The primary efficacy endpoint of clinical remission (stool frequency, rectal bleeding, endoscopy
sub-scores) was met by three out of six patients from each cohort. Out of the patients from both the cohorts that did
not meet the primary endpoint (n=6), all of the patients achieved a partial response (two out of three criteria met).
Rate of clinical remission was 60%, 67%, and 75% in the cohort A, B, and C, respectively. Endoscopy subscore of 1
was achieved by 80%, 67%, and 75% of patients, from the cohort A, B, and C, respectively. Zero rectal bleeding
subscore was observed in 80% and 100% of patients of patients from cohort A and cohort B & C, respectively. All
patients achieved stool frequency subscore. In Full MMDAI assessment (Stool Frequency + rectal bleeding +
endoscopy findings + Physician’s Global Assessment), 100% reduction in 2 patients in Cohort A and 2 patients in
Cohort B, 50-75% reduction in 2 patients in Cohort A and 4 patients in Cohort B and 20% reduction in 1 patient in
Cohort A was reported. According to partial MMDAI assessment (Stool Frequency + rectal bleeding + endoscopy
findings), 100% reduction in 3 patients in Cohort A and 3 patients in Cohort B and 50-83% reduction in 2 patients in
Cohort A and 3 patients in Cohort B was observed. All 12 patients reported an improvement in quality of life as
measured by the SIBDQ, with, over 40% of patients reporting significant improvements, ranging approximately from
20 points to more than 50 points higher on the 70-point SIBDQ scale. Interim results in four patients treated with
brilacidin for ulcerative proctitis demonstrated clinically meaningful improvements, as measured by the Modified
Mayo Disease Activity Index (MMDAI). At Day 42, on the Partial MMDAI (accounting for Stool Frequency, Rectal
Bleeding, and Physician’s Global Assessment scores), 2 of 4 patients achieved full response (100% reduction) and the
other 2 patients had notable improvement (50% reduction). At Day 42, on the MMDAI (equivalent to Partial MMDAI
+ Endoscopy score; completed by 3 of 4 patients), 1 of 3 patients achieved full response (100% reduction) and 2 of 3
patients had notable improvement (50% reduction). Patient quality of life, as assessed by the Short Inflammatory
Bowel Disease Questionnaire (SIBDQ), was improved after 6-weeks of treatment with
brilacidin[171][139][132][143][141].
Future Events
Expected Date Event Type Description Updated
31 Dec 2022 Trial Update
Innovation Pharmaceuticals plans a
phase III trial for Stomatitis (PO), in
2022 (9324224)
20 May 2021
31 Jan 2022 Trial Update
Innovation Pharmaceuticals plans a
phase III trial for Oral mucositis in
2022 [25] ()
03 Dec 2021
31 Dec 2021 Trial Update
Alfasigma plans a phase II clinical
trial for Ulcerative
proctitis/Ulcerative
proctosigmoiditis (Rectal) in 2021
(9324224) [129] ()
20 May 2021
31 Dec 2021 Trial Update
Innovation Pharmaceuticals plans a
phase II trial for Ulcerative colitis
(PO, Capsule) in 2021 (9324224)
20 May 2021
05 Feb 2021 Trial Update
Innovation Pharmaceuticals plans a
phase II trial for COVID-2019
infections in February 2021 (IV) [43]
()
01 Feb 2021
31 Dec 2020 Regulatory Status
Innovation Pharmaceuticals expects
IND application approval from the
FDA for COVID-2019 infection
before Q4 2020 [37] ()
22 Dec 2020
30 Nov 2020 Regulatory Status
Innovation Pharmaceuticals
announces intention to submit an
investigational drug (IND)
application with the US FDA for
COVID-2019 infections in
November 2020 [19] ()
24 Nov 2020
30 Sep 2020 Trial Update
Innovation Pharmaceuticals plans a
phase II trial for Ulcerative colitis
(PO, Controlled release tablet) in
USA by September 2020
(700319549) [168] ()
17 Mar 2020
15 Sep 2020 Regulatory Status
Innovation Pharmaceuticals plans
interactions with the US FDA for
COVID-2019 infections in early
September 2020 [29] ()
06 Oct 2020
16 Mar 2020 Trial Update
Regional Biocontainment Labs plans
to commence testing of brilacidin for
COVID-2019-infections in March
2020 [147] ()
03 Apr 2020
17 Jan 2020 Trial Update
Innovation Pharmaceuticals and
BDD Pharma plan a phase I trial for
Ulcerative colitis (In volunteers) in
United Kingdom in (PO,Tablet) in
January 2020 [127] ()
21 Jan 2020
31 Oct 2018 Regulatory Status
Innovation Pharmaceuticals plans an
end-of-phase II meeting with the
FDA in October 2018 [170] ()
17 Nov 2018
Development History
Event Date Update Type Comment
18 Nov 2021 Regulatory Status
Innovation Pharmaceuticals announces
compassionate use of brilacidin for COVID-19
infections [25] ()
Updated 03 Dec 2021
18 Nov 2021 Trial Update
Innovation Pharmaceuticals plans a phase III trial
for Oral mucositis in 2022 [25] ()
Updated 03 Dec 2021
25 Oct 2021 Phase Change - Preclinical
Preclinical trials in Ebola virus infections in USA
(unspecified route) [6] ()
Updated 03 Nov 2021
25 Oct 2021 Phase Change - Preclinical
Preclinical trials in Marburg virus disease in USA
(unspecified route) [6] ()
Updated 03 Nov 2021
25 Oct 2021 Phase Change - Preclinical
Preclinical trials in Nipah virus infections in USA
(unspecified route) [6] ()
Updated 03 Nov 2021
25 Oct 2021 Phase Change - Preclinical
Preclinical trials in West Nile virus infections in
USA (unspecified route) [6] ()
Updated 03 Nov 2021
25 Oct 2021 Phase Change - Preclinical
Preclinical trials in Zika virus infection in USA
(unspecified route) [6] ()
Updated 03 Nov 2021
13 Aug 2021 Biomarker Update
Biomarkers information updated
Updated 02 Oct 2021
30 Jul 2021 Trial Update
Innovation Pharmaceuticals completes a phase II
trial in COVID-19 infections in USA and Russia
(NCT04784897)
Updated 25 Aug 2021
21 Jul 2021 Scientific Update
Antiviral data from a preclinical trial in Viral
infections presented at the American Society of
Virology’s 40th Annual Meeting (ASV-2021) [38] (
)
Updated 26 Jul 2021
03 Jun 2021 Trial Update
Innovation Pharmaceuticals completes enrolment
in its phase II trial for COVID-2019 infections in
USA and Russia (IV) [12] () (NCT04784897)
Updated 08 Jun 2021
27 May 2021 Phase Change - Preclinical
Preclinical trials in Alphavirus infections in USA
(unspecified route), prior to May 2021 [14] ()
Updated 01 Jun 2021
27 May 2021 Phase Change - Preclinical
Preclinical trials in Bunyavirus infections in USA
(unspecified route), prior to May 2021 [14] ()
Updated 01 Jun 2021
20 May 2021 Trial Update
Innovation Pharmaceuticals plans a phase II trial
for Ulcerative colitis (PO, Capsule) in 2021 [21] ()
Updated 20 May 2021
20 May 2021 Trial Update
Innovation Pharmaceuticals plans a phase III trial
for Stomatitis (PO), in 2022 [21] ()
Updated 20 May 2021
02 Mar 2021 Scientific Update
Pharmacodynamics data from a preclinical study
in COVID-2019 infections released by Innovation
Pharmaceuticals [28] ()
Updated 04 Mar 2021
22 Feb 2021 Phase Change - II
Phase-II clinical trials in COVID-2019 infections
in Russia (IV) (NCT04784897)
Updated 09 Mar 2021
22 Feb 2021 Phase Change - II
Phase-II clinical trials in COVID-2019 infections
in USA (IV) (NCT04784897)
Updated 09 Mar 2021
29 Jan 2021 Trial Update
Innovation Pharmaceuticals plans a phase II trial
for COVID-2019 infections in February 2021 (IV)
[43] ()
Updated 01 Feb 2021
14 Jan 2021 Regulatory Status
Brilacidin receives Fast Track designation for
COVID-2019 infections [IV] in USA [26] ()
Updated 19 Jan 2021
21 Dec 2020 Regulatory Status
US FDA approves IND application to proceed
with initiation of a Phase II trial in hospitalized
patients COVID-2019 infection [15] ()
Updated 22 Dec 2020
30 Nov 2020 Phase Change - Preclinical
Preclinical trials in Coronavirus infections in USA
(unspecified route) [44] ()
Updated 02 Dec 2020
16 Nov 2020 Regulatory Status
Innovation Pharmaceuticals announces intention to
submit an investigational drug (IND) application
with the US FDA for COVID-2019 infections in
November 2020 [19] ()
Updated 24 Nov 2020
16 Nov 2020 Regulatory Status
Innovation Pharmaceuticals submits an overseas
clinical trial application with the governing health
agency for COVID-2019 infections [19] ()
Updated 24 Nov 2020
16 Nov 2020 Trial Update
Innovation Pharmaceuticals plans a phase III trial
for Stomatitis (Prevention) (PO) [19] ()
Updated 24 Nov 2020
02 Oct 2020 Regulatory Status
Innovation Pharmaceuticals plans to schedule a
pre-IND meeting with the US FDA for
COVID-2019 infections [18] ()
Updated 06 Oct 2020
15 Sep 2020 Scientific Update
Pharmacodynamics data from a preclinical studies
in COVID-2019 infections released by Innovation
Pharmaceuticals [27] ()
Updated 17 Sep 2020
24 Aug 2020 Regulatory Status
Innovation Pharmaceuticals plans interactions with
the US FDA for COVID-2019 infections in early
September 2020 [29] ()
Updated 06 Oct 2020
24 Aug 2020 Scientific Update
Pharmacodynamics data from preclinical studies in
COVID-2019 infections released by Innovation
Pharmaceuticals [29] () [30] ()
Updated 26 Aug 2020
04 Aug 2020 Phase Change - Preclinical
Preclinical trials in COVID-2019 infections
(Prevention) in USA (IV) [33] ()
Updated 07 Aug 2020
21 Jul 2020 Scientific Update
Pharmacodynamics data from a preclinical study
in COVID-2019 infections released by Innovation
Pharmaceuticals [31] ()
Updated 22 Jul 2020
13 Jul 2020 Regulatory Status
Innovation Pharmaceuticals expects IND
application approval from the FDA for
COVID-2019 infection before Q4 2020 [37] ()
Updated 22 Dec 2020
18 Jun 2020 Regulatory Status
Innovation Pharmaceuticals intends to seek FDA
guidance for a planned trial for COVID-2019
infections in USA [34] ()
Updated 22 Jun 2020
18 Jun 2020 Scientific Update
Pharmacodynamics data from a preclinical study
in COVID-2019 infections released by Innovation
Pharmaceuticals [34] ()
Updated 22 Jun 2020
26 May 2020 Scientific Update
Pharmacodynamics data from a preclinical study
in COVID-2019 infections released by Innovation
Pharmaceuticals [39] ()
Updated 01 Jun 2020
19 May 2020 Phase Change - Preclinical
Preclinical trials in COVID-2019 infections in
USA (IV) [35] ()
Updated 26 May 2020
19 May 2020 Scientific Update
Pharmacodynamics data from preclinical studies in
COVID-2019 infections released by Innovation
Pharmaceuticals [35] ()
Updated 26 May 2020
22 Apr 2020 Licensing Status
Brilacidin is available for licensing as of 20 Apr
2020 for the treatment of COVID-19 infections
http://www.ipharminc.com/collaborations [2] ()
Updated 22 Apr 2020
06 Apr 2020 Trial Update
Innovation Pharmaceuticals plans a clinical trial
for COVID-2019 infections in the US and Europe
[40] () [35] ()
Updated 14 Apr 2020
01 Apr 2020 Scientific Update
Pharmacodynamics data from early research phase
in COVID-2019 infections released by Innovation
Pharmaceuticals [41] ()
Updated 03 Apr 2020
17 Mar 2020 Phase Change
Early research in COVID-2019 infections in USA
(IV) [42] ()
Updated 23 Mar 2020
10 Mar 2020 Trial Update
Regional Biocontainment Labs plans to commence
testing of brilacidin for COVID-2019-infections in
March 2020 [147] ()
Updated 03 Apr 2020
05 Mar 2020 Trial Update
Innovation Pharmaceuticals plans a phase II trial
for Ulcerative colitis (PO, Controlled release
tablet) in USA by September 2020 [168] ()
Updated 17 Mar 2020
24 Feb 2020 Company Involvement
Innovation Pharmaceuticals submits preliminary
summary of brilacidin's potential for
COVID-2019-infections to the Biomedical
Advanced Research and Development Authority
(BARDA) [146] ()
Updated 28 Feb 2020
13 Feb 2020 Scientific Update
Top-line adverse events and pharmacokinetics data
from the phase I trial in Inflammatory bowel
diseases released by Innovation Pharmaceuticals
[45] ()
Updated 20 Feb 2020
12 Feb 2020 Trial Update
Innovation Pharmaceuticals completes a phase I
trial in Inflammatory bowel diseases (In
volunteers) in United Kingdom (PO)
(NCT04240223)
Updated 28 Feb 2020
06 Feb 2020 Phase Change - I
Phase-I clinical trials in Inflammatory bowel
diseases (In volunteers) in United Kingdom (PO)
[45] ()
Updated 20 Feb 2020
17 Jan 2020 Phase Change - I
Phase-I clinical trials in Ulcerative proctitis (In
volunteers) in USA (PO, Controlled release) [127] ()
[130] ()
Updated 21 Jan 2020
17 Jan 2020 Trial Update
Innovation Pharmaceuticals and BDD Pharma plan
a phase I trial for Ulcerative colitis (In volunteers)
in United Kingdom in (PO,Tablet) in January 2020
[127] ()
Updated 21 Jan 2020
26 Dec 2019 Regulatory Status
Medicines and Healthcare products Regulatory
Agency approves a Clinical Trial Application for a
phase I trial of brilacidin in Ulcerative Colitis in
United Kingdom (PO,Tablet) [128] ()
Updated 30 Dec 2019
10 Dec 2019 Trial Update
Alfasigma plans a phase II clinical trial for
Ulcerative proctitis/Ulcerative proctosigmoiditis
(Rectal) in 2021 [21] () [129] ()
Updated 20 May 2021
10 Dec 2019 Regulatory Status
Innovation Pharmaceuticals submits regulatory
documents to the respective health authority for
Ulcerative colitis for planned clinical trial [129] ()
Updated 17 Dec 2019
25 Nov 2019 Regulatory Status
The US FDA waives Paediatric Investigation Plan
for Stomatitis in patients with Head and neck
cancer [98] ()
Updated 28 Nov 2019
13 Nov 2019 Licensing Status
Brilacidin is available for licensing for Stomatitis
(Prevention) as of 13 Nov 2019.
www.ipharminc.com
Updated 26 Nov 2019
16 Sep 2019 Phase Change - Preclinical
Preclinical trials in Ulcerative colitis in United
Kingdom (PO, Tablet) before September 2019
[144] ()
Updated 18 Sep 2019
22 Jul 2019 Licensing Status
Innovation Pharmaceuticals signs a license
agreement with Alfasigma for the development
and commercialisation of brilacidin in Ulcerative
proctitis/Ulcerative proctosigmoiditis [3] ()
Updated 25 Jul 2019
30 Jun 2019 Trial Update
Innovation Pharmaceuticals plans a phase III trial
for Stomatitis [96] () [37] ()
Updated 06 May 2020
06 Jun 2019 Licensing Status
Innovation Pharmaceuticals collaborates with
BDD pharma for the developing oral tablets for
Inflammatory bowel disease [4] ()
Updated 12 Jun 2019
19 Feb 2019 Patent Information
Innovation Pharmaceuticals has patent protection
for brilacidin in USA [162] ()
Updated 22 Feb 2019
14 Jan 2019 Phase Change - Preclinical
Preclinical trials in Inflammatory bowel diseases
in USA (PO) [47] ()
Updated 17 Jan 2019
14 Jan 2019 Scientific Update
Pharmacokinetics data from a simulated gastric
fluid model in Inflammatory bowel disease
released by Innovation Pharmaceuticals [47] ()
Updated 17 Jan 2019
14 Jan 2019 Trial Update
Innovation Pharmaceuticals plans a phase III trial
in Stomatitis (PO) [47] ()
Updated 17 Jan 2019
14 Jan 2019 Trial Update
Innovation Pharmaceuticals plans clinical
development in Ulcerative colitis and Crohn's
disease (PO) and Ulcerative proctitis (Foam/gel)
[47] ()
Updated 17 Jan 2019
02 Jan 2019 Patent Information
Innovation Pharmaceuticals receives "issue
notification" for a new US patent from the USPTO
[163] ()
Updated 07 Jan 2019
17 Dec 2018 Regulatory Status
The US FDA completes an End-of-Phase 2
meeting for clinical development programme of
brilacidin in Stomatitis (Prevention, in head and
neck cancer patients receiving chemoradiation) [99]
()
Updated 21 Dec 2018
01 Nov 2018 Patent Information
Innovation Pharmaceuticals has patent protection
for brilacidin in USA [164] ()
Updated 09 Nov 2018
01 Nov 2018 Patent Information
USPTO issues Notice of Allowance for oral,
buccal, and sublingual pharmaceutical
compositions of brilacidin [164] ()
Updated 09 Nov 2018
24 Oct 2018 Regulatory Status
The US FDA grants an End-of-Phase 2 meeting
for clinical development programme of brilacidin
in Stomatitis (Prevention, in head and neck cancer
patients receiving chemoradiation) [100] ()
Updated 30 Oct 2018
12 Oct 2018 Scientific Update
Pharmacodynamics data from preclinical studies
released by Innovation Pharmaceuticals [169] ()
Updated 22 Oct 2018
20 Sep 2018 Regulatory Status
Innovation Pharmaceuticals plans an end-of-phase
II meeting with the FDA in October 2018 [170] ()
Updated 17 Nov 2018
05 Sep 2018 Trial Update
Innivation Pharmaceuticals plans a clinical trials
for Atopic dermatitis and Acne
Updated 07 Sep 2018
28 Aug 2018 Phase Change - No development reported
No recent reports of development identified for
preclinical development in Diabetic-foot-ulcer in
USA
Updated 28 Aug 2018
28 Jun 2018 Phase Change - No development reported
No recent reports of development identified for
preclinical development in Wounds in USA
Updated 28 Jun 2018
09 May 2018 Scientific Update
Updated efficacy data from a phase II trial in
Stomatitis released by Innovation Pharmaceuticals
[108] ()
Updated 16 May 2018
09 May 2018 Trial Update
Innovation Pharmaceuticals completes a phase II
trial in Stomatitis (Prevention) in USA [108] ()
(NCT02324335)
Updated 16 May 2018
28 Feb 2018 Phase Change - No development reported
No recent reports of development identified for
preclinical development in Otitis in USA (Otic)
Updated 28 Feb 2018
08 Jan 2018 Phase Change - Discontinued(Preclinical)
Discontinued - Preclinical for Intestinal infections
in USA (PO) (Innovation pipeline, January 2018)
Updated 08 Jan 2018
08 Jan 2018 Phase Change - Discontinued(Preclinical)
Discontinued - Preclinical for Ophthalmic
infections in USA (Ophthalmic) (Innovation
pipeline, January 2018)
Updated 08 Jan 2018
08 Jan 2018 Phase Change - Discontinued(Preclinical)
Discontinued - Preclinical for Ulcerative colitis in
USA (Topical) (Innovation pipeline, January
2018)
Updated 08 Jan 2018
03 Jan 2018 Scientific Update
Updated efficacy data from a phase II trial in
Stomatitis (Prevention) released by Innovation
Pharmaceuticals [107] ()
Updated 08 Jan 2018
28 Dec 2017 Phase Change - No development reported
No recent reports of development identified for
preclinical development in Ophthalmic-infections
in USA (Ophthalmic)
Updated 28 Dec 2017
12 Dec 2017 Patent Information
Innovation Pharmaceuticals has patent protection
for Brilacidin in Europe, Japan, Taiwan, China,
Australia and South Africa [165] ()
Updated 15 Dec 2017
12 Dec 2017 Patent Information Innovation Pharmaceuticals has patents pending
for Brilacidin in Russia and South Korea [165] ()
Updated 15 Dec 2017
11 Dec 2017 Scientific Update
Top line efficacy and adverse events data from a
phase II trial in Stomatitis (Prevention) released by
Innovation Pharmaceuticals [110] ()
Updated 15 Dec 2017
22 Nov 2017 Trial Update
Innovation Pharmaceuticals completes a phase II
trial in Stomatitis (Prevention) in USA (Topical)
[104] ()
Updated 01 Nov 2017
16 Nov 2017 Regulatory Status
Innovation Pharmaceuticals plans to follow
expedited approval procedure for Stomatitis in
Europe [103] ()
Updated 22 Nov 2017
04 Nov 2017 Phase Change - No development reported
No recent reports of development identified for
preclinical development in Intestinal-infections in
USA (PO)
Updated 04 Nov 2017
04 Nov 2017 Phase Change - No development reported
No recent reports of development identified for
preclinical development in Ulcerative-colitis in
USA (Topical)
Updated 04 Nov 2017
26 Oct 2017 Regulatory Status
Innovation Pharmaceuticals plans to apply for
FDA Breakthrough Therapy Designation for
Stomatitis [104] ()
Updated 01 Nov 2017
26 Oct 2017 Trial Update
Innovation Pharmaceuticals plans a pivotal phase
III trial in Stomatitis [104] ()
Updated 01 Nov 2017
07 Aug 2017 Trial Update
Cellceutix plans a clinical trial for Atopic
dermatitis [111] ()
Updated 08 Aug 2017
07 Aug 2017 Trial Update
Innovation Pharmaceuticals completes enrolment
in its phase II trial for Stomatitis (Prevention) in
USA [111] ()
Updated 08 Aug 2017
13 Jul 2017 Scientific Update
Additional efficacy data from a phase II trial in
Ulcerative colitis released by Innovation
Pharmaceuticals [171] ()
Updated 19 Jul 2017
26 Jun 2017 Trial Update
Innovation pharmaceuticals completes a phase II
trial in Ulcerative colitis in USA [131] ()
Updated 04 Jul 2017
07 Jun 2017 Company Involvement
Cellceutix is now called Innovation
Pharmaceuticals
Updated 09 Jun 2017
18 May 2017 Trial Update
Cellceutix Corporation completes enrolment in its
phase II trial for Ulcerative colitis [142] ()
Updated 25 May 2017
27 Mar 2017 Scientific Update
Preliminary interim efficacy, pharmacokinetics
and adverse events data from a phase II trial in
Stomatits released by Cellceutix [113] ()
Updated 04 Apr 2017
08 Mar 2017 Scientific Update
Interim efficacy, pharmacokinetics and adverse
events data from a phase II proof-of-concept trial
in Ulcerative colitis released by Cellceutix [143] ()
Updated 19 Mar 2017
17 Jan 2017 Trial Update
Cellceutix completes enrolment in the second
cohort in its phase II trial for Ulcerative colitis in
USA (Rectal) [135] ()
Updated 23 Jan 2017
07 Dec 2016 Scientific Update
Interim adverse events data from a phase II
proof-of-concept trial in Ulcerative colitis released
by Cellceutix [136] ()
Updated 13 Dec 2016
07 Dec 2016 Trial Update
Cellceutix plans clinical trials for hidradenitis
suppurativa [136] ()
Updated 13 Dec 2016
07 Dec 2016 Trial Update
Cellceutix plans gastroenterological studies for
foam and tablet formulations of brilacidin
(Cellceutix website)
Updated 13 Dec 2016
01 Nov 2016 Phase Change - Preclinical
Preclinical trials in Atopic dermatitis in USA
(Topical) (Cellceutix website, November 2016)
[150] ()
Updated 13 Dec 2016
01 Nov 2016 Phase Change - Preclinical
Preclinical trials in Hidradenitis suppurativa in
USA (Topical) (Cellceutix website, November
2016) [150] ()
Updated 13 Dec 2016
26 Oct 2016 Phase Change - Preclinical
Preclinical trials in Acne in USA (Topical) [149] ()
[150] ()
Updated 13 Dec 2016
26 Oct 2016 Trial Update Cellceutix plans clinical trials for Acne [149] ()
Updated 28 Oct 2016
10 Oct 2016 Scientific Update
Interim pharmacokinetics and efficacy data from a
phase II trial in Ulcerative colitis released by
Cellceutix [139] ()
Updated 14 Oct 2016
15 Jun 2016 Phase Change - II
Phase-II clinical trials in Ulcerative proctitis in
USA (Rectal) [11] () [172] ()
Updated 22 Jun 2016
26 Feb 2016 Regulatory Status
Cellceutix submits Special Protocol Assessment
(SPA) to the US FDA for its planned phase III
clinical trial
Updated 02 Mar 2016
09 Feb 2016 Regulatory Status
Cellceutix announces intention to submit Special
Protocol Assessment (SPA) to the US FDA for its
planned phase III clinical trial [50] ()
Updated 11 Feb 2016
25 Nov 2015 Regulatory Status
Brilacidin receives Fast Track designation for
Stomatitis [Topical,Liquid] (Prevention) in USA
[105] ()
Updated 29 Nov 2015
15 Sep 2015 Regulatory Status
Cellceutix submits Paediatric Study Plan (PSP) to
the US FDA for Skin and soft tissue infections [52]
()
Updated 15 Oct 2015
31 Aug 2015 Active Status Review
Brilacidin is still in phase-II development for Skin
and soft tissue infections in Canada, Russia,
Ukraine and USA
Updated 31 Aug 2015
20 Jul 2015 Regulatory Status
The US FDA recommends advancing the
brilacidin programme to phase III development
[53] ()
Updated 22 Jul 2015
01 Jun 2015 Phase Change
Early research in Hidradenitis suppurativa in USA
(unspecified route)
Updated 06 Jul 2015
21 Apr 2015 Trial Update
Cellceutix plans a phase II trial for Ulcerative
colitis in Europe (Topical) [56] ()
Updated 27 May 2015
21 Apr 2015 Trial Update
Cellceutix plans a phase III trial for Skin and soft
tissue infections in USA [56] ()
Updated 26 May 2015
08 Dec 2014 Trial Update
Cellceutix plans to initiate a phase II trial in
Stomatitis in USA
Updated 14 Mar 2015
08 Dec 2014 Regulatory Status
Brilacidin receives Qualified Infectious Disease
Product (QIDP) designation from the FDA for
Acute bacterial skin and skin structure infections
[95] ()
Updated 09 Dec 2014
24 Nov 2014 Licensing Status
Cellceutix enters into an agreement with a division
of one of the largest US pharmaceutical companies
to test brilacidin for the prevention of infection in
certain implanted devices [7] ()
Updated 03 Dec 2014
11 Nov 2014 Licensing Status
Brilacidin is available for licensing in World as of
11 Nov 2014. http://cellceutix.com/
Updated 13 Nov 2014
23 Oct 2014 Scientific Update
Top-line efficacy and adverse events data from a
phase IIb trial in Skin and soft tissue infections
released by Cellceutix [58] ()
Updated 14 Nov 2014
13 Oct 2014 Regulatory Status
US FDA approves IND application for phase II
trial of brilacidin in Stomatitis [60] ()
Updated 15 Oct 2014
09 Sep 2014 Regulatory Status
Cellceutix files an IND application with the US
FDA for Stomatitis [61] ()
Updated 12 Sep 2014
31 Aug 2014 Trial Update
Cellceutix completes a phase IIb trial in Skin and
soft tissue infections in USA [59] ()
(NCT02052388)
Updated 30 Oct 2014
19 Aug 2014 Trial Update
Cellceutix completes enrolment in a phase IIb trial
for Skin and soft tissue infections in USA
(NCT02052388)
Updated 21 Aug 2014
14 Aug 2014 Phase Change - II
Phase-II clinical trials in Stomatitis (Prevention) in
USA (Topical) (NCT02324335)
Updated 27 May 2015
14 Jul 2014 Phase Change - Preclinical
Preclinical trials in Diabetic foot ulcer in USA
(unspecified route)
Updated 14 Aug 2014
19 May 2014 Scientific Update
Pharmacodynamics data from a preclinical study
in Wounds (non-infected) released by Cellceutix
[153] ()
Updated 26 May 2014
01 May 2014 Phase Change - Preclinical
Preclinical trials in Wounds in USA (unspecified
route)
Updated 26 May 2014
24 Feb 2014 Scientific Update
Pharmacodynamics data from a preclinical trial in
Otitis media released by Cellceutix [8] ()
Updated 25 Feb 2014
18 Feb 2014 Phase Change - II
Phase-II clinical trials in Skin and soft tissue
infections in USA (IV)
Updated 19 Feb 2014
01 Jan 2014 Phase Change - Preclinical
Preclinical trials in Otitis in USA (Otic)
Updated 24 Jan 2014
20 Dec 2013 Regulatory Status
Cellceutix applies for orphan drug status for
briliacidin for oral mucositis in USA [125] ()
Updated 24 Dec 2013
04 Nov 2013 Phase Change - Preclinical
Preclinical trials in Ophthalmic infections in USA
(Ophthalmic)
Updated 06 Nov 2013
16 Sep 2013 Phase Change - Preclinical Preclinical trials in Ulcerative colitis in USA
(Topical)
Updated 04 Dec 2014
16 Sep 2013 Phase Change - Preclinical
Preclinical trials in Intestinal infections in USA
(PO)
Updated 06 Nov 2013
04 Sep 2013 Licensing Status
Cellceutix acquires brilacidin from PolyMedix [9] (
)
Updated 11 Sep 2013
01 Apr 2013 Company Involvement PolyMedix files for Chapter 7 bankruptcy [9] ()
Updated 11 Sep 2013
20 Sep 2012 Company Involvement
PolyMedix receives a Phase I grant from the
National Cancer Institute for preclinical
development of brilacidin in Stomatitis [124] ()
Updated 24 Sep 2012
12 Sep 2012 Scientific Update
Pharmacokinetics data from a preclinical study & a
phase I trial in Healthy volunteers presented at the
52nd Interscience Conference on Antimicrobial
Agents and Chemotherapy (ICAAC-2012) [81] ()
Updated 10 Oct 2012
11 Sep 2012 Scientific Update
Final efficacy and adverse event data from a phase
II trial in acute bacterial Skin and soft tissue
infections released by PolyMedix [74] ()
Updated 14 Sep 2012
04 Jun 2012 Scientific Update
Pharmacodynamics data from preclinical studies in
Stomatitis presented at the 48th Annual Meeting of
the American Society of Clinical Oncology
(ASCO-2012) [123] ()
Updated 05 Jun 2012
23 Apr 2012 Scientific Update
Final efficacy and adverse events data from a
phase II trial in Skin and soft tissue infections
released by PolyMedix [173] ()
Updated 24 Apr 2012
02 Apr 2012 Scientific Update
Antimicrobial data from preclinical trials in
Bacterial infections presented at the 21st Annual
European Congress of Clinical Microbiology and
Infectious Disease (ECCMID-2012) [174] ()
Updated 04 Apr 2012
01 Mar 2012 Trial Update
PolyMedix completes its phase II trial for Skin and
soft tissue infections in Canada, Russia and
Ukraine (NCT01211470)
Updated 11 Sep 2013
04 Jan 2012 Trial Update
PolyMedix completes enrolment in its phase II
trial for Skin and soft tissue infections in Canada,
Russia and Ukraine (NCT01211470)
Updated 06 Jan 2012
07 Dec 2011 Scientific Update
Interim efficacy and adverse events data from a
phase II trial in Skin and soft tissue infections
released by PolyMedix [175] ()
Updated 08 Dec 2011
20 Sep 2011 Scientific Update
Pharmacokinetics & adverse events data from a
phase I trial in Healthy volunteers presented at the
51st Interscience Conference on Antimicrobial
Agents and Chemotherapy (ICAAC-2011) [80] ()
Updated 27 Sep 2011
12 Sep 2011 Phase Change - II
Phase-II clinical trials in Skin and soft tissue
infections in Russia (IV)
Updated 14 Sep 2011
12 Sep 2011 Phase Change - II
Phase-II clinical trials in Skin and soft tissue
infections in Ukraine (IV)
Updated 14 Sep 2011
19 May 2011 Phase Change - Preclinical
Preclinical trials in Stomatitis in USA (Topical)
Updated 23 May 2011
10 May 2011 Scientific Update
Pharmacokinetics, antimicrobial & adverse events
data from two phase I trials in Healthy volunteers
presented at the 21st European Congress of
Clinical Microbiology and Infectious Diseases and
the 27th International Congress of Chemotherapy
(ECCMID-ICC-2011) [176] () , [83] ()
Updated 17 Jun 2011
28 Apr 2011 Scientific Update
Pharmacodynamics data from a preclinical study
in Bacterial infections released by PolyMedix [177]
()
Updated 29 Apr 2011
25 Feb 2011 Scientific Update
Final adverse events data from a Phase I trial in
Healthy volunteers released by PolyMedix [82] ()
Updated 28 Feb 2011
25 Feb 2011 Trial Update
PolyMedix completes a phase I dose-escalation
trial in Healthy volunteers in USA [82] ()
Updated 28 Feb 2011
11 Nov 2010 Phase Change - I
Phase-I clinical trials in Bacterial infections (in
volunteers) in USA (IV)
Updated 15 Nov 2010
11 Nov 2010 Regulatory Status
US FDA approves IND application for brilacidin
in Bacterial infections [84] ()
Updated 15 Nov 2010
29 Sep 2010 Phase Change - II
Phase-II clinical trials in Skin and soft tissue
infections in Canada (IV)
Updated 29 Sep 2010
31 Mar 2010 Trial Update
PolyMedix completes phase I trials in Bacterial
infections
Updated 13 Jul 2010
31 Mar 2010 Scientific Update
Final adverse events and antimicrobial data from a
phase Ib trial in Staphylococcal infections released
by PolyMedix [87] ()
Updated 01 Apr 2010
12 Mar 2010 Phase Change - Suspended(Preclinical)
Suspended - Preclinical for Intestinal infections in
USA (PO)
Updated 09 Nov 2010
12 Mar 2010 Phase Change - Suspended(Preclinical)
Suspended - Preclinical for Ophthalmic infections
in USA (Topical)
Updated 09 Nov 2010
12 Mar 2010 Scientific Update
Interim safety and antimicrobial data from a phase
I trial in Bacterial infections released by
PolyMedix [89] ()
Updated 15 Mar 2010
19 Dec 2009 Scientific Update
Adverse events and antimicrobial data from a
phase I trial in Bacterial infections released by
PolyMedix [90] ()
Updated 22 Dec 2009
15 Sep 2009 Scientific Update
Pharmacodynamics and pharmacokinetic data
from a preclinical trial in Bacterial infections
presented at the 49th Annual Interscience
Conference on Antimicrobial Agents and
Chemotherapy (ICAAC-2009) [178] () , [179] ()
Updated 07 Oct 2009
06 Jun 2009 Trial Update
PolyMedix initiates patient dosing in a phase I trial
in healthy volunteers in USA
Updated 09 Jun 2009
26 May 2009 Trial Update
PolyMedix receives regulatory clearance from
Health Canada to commence a second phase I
clinical trial of brilacidin in healthy volunteers
Updated 26 May 2009
11 Dec 2008 Scientific Update
Adverse events and pharmacokinetics data from a
phase I trial in Healthy volunteers released by
PolyMedix [93] ()
Updated 12 Dec 2008
28 Oct 2008 Scientific Update
Antimicrobial, adverse events, and
pharmacodynamics data from preclinical trials in
Bacterial infections presented at the 48th Annual
Interscience Conference on Antimicrobial Agents
and Chemotherapy and 46th Annual Meeting of
the Infectious Diseases Society of America
(ICAAC/IDSA-2008) [180] () , [181] ()
Updated 10 Nov 2008
22 Aug 2008 Phase Change - I
Phase-I clinical trials in Bacterial infections in
Canada (IV)
Updated 25 Aug 2008
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References
Cellceutix Announces Company Name Change to Innovation Pharmaceuticals Inc.
Media Release
Screening of 11,552 Compounds Identifies Innovation Pharmaceuticals Brilacidin as One of the Most
Promising Potential Inhibitors of the Novel Coronavirus COVID-19.
Media Release
Innovation Pharmaceuticals Announces License Agreement with Alfasigma S.p.A. for the Development and
Commercialization of Brilacidin in Ulcerative Proctitis/Ulcerative Proctosigmoiditis.
Media Release
Innovation Pharmaceuticals Signs Agreement for Advanced Oral Tablet Technology in Treating Inflammatory
Bowel Disease.
Media Release
Innovation Pharmaceuticals Signs Drug Product Manufacturing Contract with CoreRx to Formulate and
Package Brilacidin for Oral Mucositis in Sachet Form.
Media Release
Innovation Pharmaceuticals' COVID-19 Clinical Trial Topline Results Anticipated to Be Reported the Week of
November 8th.
Media Release
Cellceutix: December to Be Momentous Month in Company's History.
Media Release
Cellceutix Selects Dr. Reddy's Laboratories for Formulation of Brilacidin for Ophthalmic and Otitis Infections.
Media Release
Cellceutix Acquires PolyMedix Assets From Bankruptcy Court, Gains Ownership of Two Clinical Stage
Drugs, Multiple Compounds, and Equipment Assets.
Media Release
Cellceutix Announces Breakthrough in the Formulation of Its Novel Antibiotic Brilacidin(Tm), Plans Studies
to Treat Diabetic Foot Ulcers.
Media Release
Cellceutix Starts Phase 2 Trial of Brilacidin as a Novel Therapy for Ulcerative Proctitis.
Media Release
Last Patient Last Visit Completed in Innovation Pharmaceuticals Phase 2 Clinical Trial of Brilacidin for
COVID-19; Trial Database Undergoing Review in Preparation for Database Lock.
Media Release
Innovation Pharma Completes Interim Safety Data ReviewDMC Approves Increased Dosing Frequency in
Phase 2 Clinical Trial of Brilacidin in Hospitalized COVID-19 Patients.
Media Release
Patient Enrollment Reaches 90 Percent in Innovation Pharmaceuticals Phase 2 Clinical Trial of Brilacidin for
COVID-19.
Media Release
FDA Grants IND Approval for Phase 2 Clinical Trial of Innovation Pharmaceuticals Brilacidin for Treating
COVID-19.
Media Release
Innovation Pharma Provides Study Details for Ongoing Phase 2 Clinical Trial of Brilacidin in Hospitalized
COVID-19 Patients.
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Media Release
Innovation Pharmaceuticals Receives Pre-IND Response from FDA on COVID-19 Trial.
Media Release
Innovation Pharmaceuticals Announces Pre-IND Meeting Request Granted by FDA for the Study of Brilacidin
for the Treatment of COVID-19.
Media Release
Innovation Pharmaceuticals Announces Overseas Regulatory Filing Submitted For COVID-19 Clinical Study.
Media Release
Innovation Pharma Announces Brilacidin Abstract Accepted for Oral Presentation at the American Society for
Virology's Annual Meeting.
Media Release
Innovation Pharma Files Form 10-Q; Patient Enrollment in Phase 2 Clinical Trial of Brilacidin for COVID-19
Tops 70 Percent.
Media Release
Immutep To Announce New TACTI-002 and INSIGHT-004 Data in Poster Presentations and Discussion at the
ASCO 2021 Annual Meeting.
Media Release
Recruitment and Enrollment Underway at Eight Sites for Innovation Pharmas Phase 2 Clinical Trial of
Brilacidin for COVID-19.
Media Release
A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and
Safety of Brilacidin in Hospitalized Participants With COVID-19
ctiprofile
Innovation Pharmaceuticals Provides Brilacidin Program Update.
Media Release
Innovation Pharmaceuticals Brilacidin for the Treatment of COVID-19 Receives FDA Fast Track Designation.
Media Release
Laboratory Testing of Brilacidin for COVID-19 in Combination with Remdesivir Reduces Viral Load by
Nearly 100 Percent.
Media Release
Innovation Pharmaceuticals Announces Publication of Peer-Reviewed Scientific Article in the Journal Viruses
on the Anti-SARS-CoV-2 Properties of Brilacidin.
Media Release
COVID-19 Drug Candidate Brilacidin Achieves a Selectivity Index Among the Highest Reported, Exhibiting
Potent Anti-SARS-CoV-2 Activity at Low Concentrations; Clinical Trial Forthcoming.
Media Release
Innovation Pharmaceuticals and George Mason University Announce Public Release of Laboratory Testing
Results Demonstrating Brilacidins COVID-19 Treatment Potential.
Media Release
Innovation Pharmaceuticals Brilacidin Inhibits Novel Coronavirus (COVID-19) by Almost 90% at the Lowest
Concentration Tested to Date in a Human Lung Cell Line.
Media Release
Innovation Pharmaceuticals Provides Update on Brilacidin Antiviral Research.
Media Release
Innovation Pharmaceuticals and U.S. Regional Biocontainment Laboratory Nearing Completion of Brilacidin
Anti-SARS-CoV-2 (COVID-19) In Vitro Testing.
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Media Release
Innovation Pharmaceuticals Brilacidin Inhibits SARS-CoV-2 (COVID-19) by 97 Percent in a Human Lung
Cell Line.
Media Release
Innovation Pharmaceuticals Brilacidin Reduces Viral Titer of SARS-CoV-2 (COVID-19) by 75 percent After
Only 1 Hour of Preincubation in In Vitro Study at BSL-3 Facility; Demonstrates Potent and Rapid Virucidal
Activity.
Media Release
In Vitro Testing of Innovation Pharmaceuticals Brilacidin for COVID-19 Shows Consistent Anti-SARS-CoV-2
Efficacy; Manufacturing Preparation Underway for COVID-19 Clinical Trial.
Media Release
Innovation Pharmaceuticals Clinical Trial Testing of Brilacidin Against SARS-CoV-2 (COVID-19) Targeted
to Commence Q4 2020.
Media Release
Innovation Pharmaceuticals Announces New In Vitro Data Supporting Brilacidins Broad-Spectrum Antiviral
Potential Presented at the American Society of Virologys Annual Meeting.
Media Release
Innovation Pharmaceuticals Receives Data from Public Health Research Institute Showing Brilacidin Inhibits
SARS-CoV-2 (COVID-19) in a Human Cell Line.
Media Release
Brilacidin-MOA. Internet-Doc 2020;.
Available from: URL:
https://static1.squarespace.com/static/5715352e20c647639137f992/t/5e9cebd48660e44c2754fa00/1587342453349/Brilacidin+Innovation Pharmaceuticals Receives Data Supporting Brilacidins Direct Inhibition of SARS-CoV-2, the
Novel Coronavirus Responsible for COVID-19.
Media Release
Innovation Pharmaceuticals Brilacidin to be Researched as Possible Novel Coronavirus (COVID-19) Vaccine;
Brilacidin Now Being Tested as Drug and Vaccine at Different Institutions.
Media Release
Innovation Pharmaceuticals' Phase 2 Clinical Trial of Brilacidin for Treating COVID-19 Scheduled to Begin
Next Week.
Media Release
Innovation Pharmaceuticals COVID-19 Clinical Trial to Support Additional Development of Brilacidin as a
Pan-Coronavirus Therapeutic.
Media Release
Innovation Pharmaceuticals Phase 1 Trial of Brilacidin for Ulcerative Colitis Meets Primary Endpoints;
Positive Topline Results of Oral Brilacidin.
Media Release
A Phase 1, Single Dose Escalation Study to Investigate the Use of Delayed Release Tablets for Colonic
Delivery of Brilacidin in Healthy Volunteers
ctiprofile
Innovation Pharmaceuticals Completes Gastric Fluid Testing of Brilacidin Supporting Development of an Oral
Dosage Form to Treat Inflammatory Bowel Disease.
Media Release
Cellceutix Corporation Provides Business Update and Timeline of Upcoming Milestones.
Media Release
Cellceutix First Annual Shareholder Meeting December 15, 2015.
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Media Release
Cellceutix to submit special protocol assessment request to FDA for phase III clinical Study of antibiotic.
Media Release
Cellceutix Completes Lab Testing of Brilacidin for Planned Phase 3 Trial for Acute Bacterial Skin and Skin
Structure Infections.
Media Release
Cellceutix Provides Update on Its Phase 3 Preparations for ABSSSI.
Media Release
Cellceutix to Start Brilacidin Phase 3 Program in ABSSSI.
Media Release
A Phase 3, Multicenter, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Single-Dose
IV Brilacidin versus IV Vancomycin Followed by Optional PO Linezolid for the Treatment of Patients with
Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
ctiprofile
A second phase III trial of brilacidin for the treatment of acute bacterial skin and skin structure infections
ctiprofile
Cellceutix Provides Corporate Update.
Media Release
Cellceutix Reports Positive Results of Brilacidin in Microbiological Intent-to-Treat Population in Phase 2b
ABSSSI Trial; Additional Pharmacokinetic Information to Be Submitted.
Media Release
Cellceutix Announces Positive Top-Line Data From Phase 2b ABSSSI Trial; Single-Dose Brilacidin
Comparable to 7-Days of Daptomycin.
Media Release
Cellceutix Provides Update to Shareholders.
Media Release
Cellceutix Investigational New Drug (IND) Application Becomes Effective, Selects First Site for Phase 2
Clinical Trial of New Treatment for Oral Mucositis.
Media Release
Cellceutix Provides Initial Observations of Completed ABSSSI Phase 2b Trial; Company Submits
Investigational New Drug Application to FDA for Phase 2 Trial of Brilacidin-OM for Oral Mucositis.
Media Release
Cellceutix Brilacidin ABSSSI Trial Gets Positive Review by Data Safety Monitoring Board; Best Possible
Outcome, No Treatment-Related Serious Adverse Events (SAEs).
Media Release
Cellceutix Enrolls First Patients in Phase 2b ABSSSI Clinical Trial.
Media Release
Cellceutix Plans Phase 2b Trial of New Antibiotic, Reports Fifth Cohort Complete in Novel Cancer Drug
Clinical Trial.
Media Release
Cellceutix Submits Investigational New Drug Application (IND) for Clinical Trial of New Anti-Psoriasis Drug,
Enrollment Underway in Phase 2b Clinical Trials of Brilacidin.
Media Release
Cellceutix Confident in Its Formidable Antibiotic Arsenal.
Media Release
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Cellceutix Reports 20 Percent Enrollment Completed in Phase 2b Trial of Brilacidin as Short-Course Therapy
for ABSSSI.
Media Release
Cellceutix Expands to Gram-Negative Bacterial Infections.
Media Release
Cellceutix Reports 14 Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Patients Treated in Phase
2b Clinical Trial.
Media Release
Cellceutix Completes Enrollment in Phase 2b Clinical Trial of Brilacidin for Acute Bacterial Skin and Skin
Structure Infections (ABSSSI).
Media Release
PolyMedix Announces Successful Meeting With FDA for Brilacidin.
Media Release
A Randomized, Double-Blind Study Comparing Three Dosing Regimens of Brilacidin to Daptomycin in the
Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
ctiprofile
Cellceutix Announces Brilacidin Data to Be Presented by ICPD at the Joint 55th Interscience Conference on
Antimicrobial Agents & Chemotherapy (ICAAC).
Media Release
PolyMedix Presents New Data on Its Defensin-Mimetic Antibiotics at 52nd Annual ICAAC
Media Release
PolyMedix Completes Enrollment in Phase 2 Trial With PMX-30063 Defensin-Mimetic Antibiotic.
Media Release
PolyMedix Provides Updates on Lead Clinical Programs.
Media Release
PolyMedix Initiates Phase 2 Clinical Trial with Novel Antibiotic, PMX-30063.
Media Release
Randomized, Dose Ranging, Active Controlled Efficacy and Safety Evaluation of PMX-30063 As Initial
Treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Caused by Staphylococcus Aureus
ctiprofile
Multiple dose study of brilacidin [PMX 30063] in male and female volunteers in the USA
ctiprofile
Korczak B, Echols RM, Walters E. Safety and Multiple Dose Pharmacokinetics of Intravenous PMX-30063: A
Novel Class of Antibiotics. 51st-ICAAC-2011 2011; abstr. A2-035.
Available from: URL: http://link.adisinsight.com/e2Y8T
Korczak B, Liu D, Scott R. A-1284 - Metabolism and Excretion of PMX-30063: A Novel Class of Antibiotics.
52nd-ICAAC-2012 2012; abstr. A-1284.
Available from: URL:
http://www.abstractsonline.com/plan/ViewAbstract.aspx?mID=2963&sKey=17238a87-a140-41c4-a61c-b02100c9aac4&PolyMedix Successfully Completes Phase 1 Exposure Escalation Safety Study With PMX-30063 Antibiotic.
Media Release
Korczak B, Echols R, Walters E. PMX30063 - understanding neuronal effects in multi dose-phase 1 clinical
study. 21st-ECCMID-27th-ICC-2011 2011; abstr. N/A.
Available from: URL: http://www.eccmid-icc2011.org
PolyMedix Obtains Regulatory Clearance for its United States IND Application for PMX-30063 Antibiotic.
Media Release
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Phase Ib multiple-dose trial of brilacidin [PMX 30063] in volunteers.
ctiprofile
Webcast Alert: PMX-30063 Phase 1B Clinical Study Results.
Media Release
PolyMedix Successfully Completes Phase 1B Clinical Study With Novel Antibiotic PMX-30063.
Media Release
PolyMedix Announces Planned Milestones for 2010.
Media Release
PolyMedix Presents PMX-30063 Antibiotic Data at 8th World Congress on Trauma, Shock, Inflammation and
Sepsis-TSIS 2010.
Media Release
PolyMedix successfully completes main portions of phase 1B clinical study with PMX-30063 novel antibiotic
drug candidate.
Media Release
PolyMedix Initiates Dosing in Second Phase I Clinical Study of Novel Systemic Antibiotic Compound.
Media Release
Phase Ia trial of brilacidin [PMX 30063] in volunteers.
ctiprofile
PolyMedix Announces Positive Phase I Clinical Data with PMX-30063 Novel Antibiotic Drug Candidate.
Media Release
PolyMedix Receives Regulatory Clearance to Initiate Phase I Clinical Study of Novel Systemic Antibiotic
Compound.
Media Release
Cellceutix Antibiotic Brilacidin Receives QIDP Designation From FDA.
Media Release
Innovation pharmaceuticals, Form 10-K. Internet-Doc 2020;.
Available from: URL: https://www.sec.gov/Archives/edgar/data/1355250/000147793219005611/ipix_10k.htm
Cellceutix Completes Acquisition of PolyMedix Assets, Immediately Plans Brilacidin(Tm) Phase 2b Clinical
Trial for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) and Phase 2 Clinical Trial for Oral
Mucositis.
Media Release
Innovation Pharmaceuticals and FDA Agree to Waive Initial Pediatric Study Plan Requirement Regarding
Brilacidin for the Prevention of Oral Mucositis.
Media Release
Innovation Pharmaceuticals Completes End-of-Phase 2 Meeting with FDA; Brilacidin Oral Rinse to Advance
Into Phase 3 Clinical Trials for Prevention of Severe Oral Mucositis.
Media Release
Innovation Pharmaceuticals Granted End-of-Phase 2 Meeting.
Media Release
Innovation Pharmaceuticals European Subsidiary, IPIX Pharma Ltd., Granted Meeting with European
Medicines Agency (EMA) to Discuss International Phase 3 Brilacidin Oral Mucositis Program.
Media Release
Innovation Pharmaceuticals Requesting European Medicines Agency (EMA) Input for International Phase 3
Brilacidin Oral Mucositis Program.
Media Release
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Innovation Pharmaceuticals Offers Perspectives on Brilacidin as a Potential Preventative Treatment for Oral
Mucositis in Head and Neck Cancer Patients.
Media Release
Innovation Pharmaceuticals Aims to Develop First Drug for Approval in Prevention of Oral Mucositis in Head
and Neck Cancer Patients as Phase 2 Clinical Trial of Brilacidin Completes.
Media Release
FDA Grants Fast Track Designation to Cellceutix's Brilacidin-OM for Oral Mucositis.
Media Release
Innovation Pharmaceuticals Data from Phase 2 Brilacidin Oral Mucositis (OM) Trial in Head and Neck Cancer
Show Notable Reductions in Median Duration of Severe OM and in Number of Unplanned Visits/Hospital
Admissions Due to OM.
Media Release
Innovation Pharmaceuticals Brilacidin Meets Key Secondary Endpoint in Phase 2 Trial, Delays Onset of
Severe Oral Mucositis (SOM); Latest Results Further Support Topline Data Showing Trial Met Primary
Endpoint of Reducing Incidence of SOM.
Media Release
Innovation Pharmaceuticals Concludes Data Analysis of its Phase 2 Clinical Trial for Severe Oral Mucositis in
Head and Neck Cancer; Positioning to Fill a Substantial Void in Supportive Cancer Care.
Media Release
Innovation Pharmaceuticals Signs Drug Supply Contract with Evonik to Bulk Produce Commercial-Grade
Brilacidin.
Media Release
Innovation Pharmaceuticals Reports Positive Topline Results from Phase 2 Placebo-Controlled Trial of
Brilacidin for the Prevention of Oral Mucositis in Head and Neck Cancer Patients; Company Targets a
Therapeutic Leadership Position in Global OM Market.
Media Release
Innovation Pharmaceuticals Completes Patient Enrollment in Phase 2 Study of Brilacidin for the Prevention of
Severe Oral Mucositis.
Media Release
Final Patient Completes Treatment in Innovation Pharmaceuticals Phase 2 Trial of Brilacidin for Preventing
Oral Mucositis in Cancer Patients.
Media Release
Cellceutix Reports Very Encouraging Interim Analysis of Phase 2 Drug Candidate Brilacidin for Severe Oral
Mucositis (OM) in Head and Neck Cancer Patients; High Potential for Preventative Treatment.
Media Release
Enrollment in Cellceutix Phase 2 Clinical Trial of Brilacidin-OM For Oral Mucositis Expanding to Additional
Centers.
Media Release
Enrollment Begins in Cellceutix Phase 2 Trial of Brilacidin-OM to Prevent Oral Mucositis in Patients
Undergoing Chemoradiation.
Media Release
Cellceutix Reports Results for Quarter Ended March 31, 2015; Enrollment for Oral Mucositis Studies to Begin
This Month.
Media Release
Phase 2 Study to Evaluate the Efficacy & Safety of Brilacidin Oral Rinse Administered Daily for 7 Weeks in
Attenuating Oral Mucositis in Patients With Head & Neck Cancer Receiving Chemoradiation
ctiprofile
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Cellceutix Prepares for Phase 2 Clinical Trial of Brilacidin-OM for Oral Mucositis.
Media Release
Patient Enrollment in Cellceutix Phase 2 Clinical Trial of Brilacidin-OM for Oral Mucositis Targeted to Begin
in December 2014.
Media Release
Cellceutix Phase 2b Clinical Trial of Brilacidin Accepted for Oral Presentation at the European Congress of
Clinical Microbiology and Infectious Diseases (ECCMID).
Media Release
Cellceutix's Clinical Trial of Anti-Cancer Agent Kevetrin Meeting Its Goals, Approaching End of Trial.
Media Release
PolyMedix PMX-30063 Defensin-Mimetic Antibiotic Compound Shows Promising Activity for Oral
Mucositis.
Media Release
New Data on PMX-30063 Presented at ASCO Suggest Strong Potential as Treatment for Oral Mucositis.
Media Release
PolyMedix Receives Grant From National Cancer Institute to Study Brilacidin for Oral Mucositis
Media Release
Cellceutix Files Orphan Drug Designation Application for Brilacidin for Oral Mucositis With US FDA.
Media Release
Innovation Pharmaceuticals Completes Dosing in Phase 1 Trial for New Oral Ulcerative Colitis Drug.
Media Release
Innovation Pharmaceuticals Announces Dose Escalation.
Media Release
Innovation Pharmaceuticals: Patient Screening for Phase 1 Trial of Oral Brilacidin in Ulcerative Colitis
Program On Track for Early January.
Media Release
Innovation Pharmaceuticals Provides Update on Clinical Trials and Revenue Potential of Brilacidin in
Inflammatory Bowel Diseases.
Media Release
Innovation Pharmaceuticals Announces Dosing of First Cohort in Phase 1 Trial of Oral Brilacidin in Ulcerative
Colitis Program; Topline Results Anticipated Early Q1 2020.
Media Release
Innovation Pharmaceuticals Completes Treatments in Phase 2 PoC Trial for Induction of Remission in
Inflammatory Bowel Disease; Topline Results with Endoscopic Response to Be Presented July 13, 2017.
Media Release
Cellceutix Releases Favorable Topline Findings as Part of Interim Analysis of Phase 2 Drug Candidate
Brilacidin for the Treatment of Inflammatory Bowel Disease.
Media Release
Cellceutix Phase 2 Brilacidin Trial Progresses to Highest Dose Cohort for the Induction of Remission of
Mild-to-Moderate Ulcerative Colitis.
Media Release
Cellceutixs Brilacidin Demonstrates Promise in Treating Ulcerative Colitis Supported by Endoscopic
Assessment, Patient-Reported Outcomes.
Media Release
Cellceutix Completes Enrollment in Second of Three Planned Cohorts in Phase 2 Clinical Trial of Brilacidin
for Inflammatory Bowel Disease.
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Media Release
Cellceutix Phase 2 Trial Dose Escalates in 2nd Cohort for Brilacidin as a Novel Anti-Inflammatory Drug
Candidate for Ulcerative Colitis.
Media Release
Cellceutix Receives Preliminary Approval for Clinical Trial of Brilacidin for Ulcerative Proctitis.
Media Release
Novocure Presents Interim STELLAR Results at IASLC Suggesting Treatment with Tumor Treating Fields
Plus Chemotherapy may Extend Survival of Patients with Mesothelioma.
Media Release
Cellceutix Phase 2 Trial Initial Data Shows Potential of Brilacidin as a Novel Anti-Inflammatory Drug
Candidate for the Induction of Remission of Mild-to-Moderate Ulcerative Colitis.
Media Release
Cellceutix Receives Update on First Patient Enrolled in Phase 2 Proof-of-Concept Study of Brilacidin for
Ulcerative Proctitis.
Media Release
Phase II study of brilacidin for the treatment of Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS)
ctiprofile
Cellceutix Completes Patient Enrollment of Final Cohort in Phase 2 Trial of Brilacidin for Inflammatory
Bowel Disease; Topline Results Anticipated in July.
Media Release
Cellceutix Releases Preliminary Efficacy and Safety Data in Interim Analysis of First Two Cohorts in Phase 2
Trial of Brilacidin for the Induction of Remission of Mild-to-Moderate Ulcerative Colitis.
Media Release
Innovation Pharmaceuticals Announces Successful Formulation of Oral Brilacidin Tablets; Upcoming Clinical
Trial to Target Delivery to the Colon.
Media Release
Innovation Pharmaceuticals Provides Scientific Rationale and Clinical Development Perspectives for
Brilacidin as a Potential Novel Coronavirus COVID-19 Treatment.
Media Release
Innovation Pharmaceuticals Submits Material Transfer Agreement to Study Lead Defensin Mimetic Brilacidin
for Coronavirus (COVID-19).
Media Release
U.S. Regional Biocontainment Lab to Begin Testing of Brilacidin Against Coronavirus (COVID-19) Next
Week.
Media Release
Innovation Pharmaceuticals Exploring Lead Defensin Mimetic Drug Candidate Brilacidin as Potential Novel
Coronavirus Treatment.
Media Release
Cellceutix Novel Anti-Inflammatory Phase 2 Drug Candidate Brilacidin Builds Momentum Across Multiple
Clinical Indications.
Media Release
Innovation Pharmaceuticals Brilacidin Franchise Anchored in Three Clinical Indications Oral Mucositis,
Inflammatory Bowel Disease and Serious Skin Infections; Expands into Dermatologic Diseases.
Media Release
Innovation Pharmaceuticals Phase 2b Psoriasis Study On-Track for Completion in December 2017; Company a
Sponsor at Upcoming Symposium on Hidradenitis Suppurativa.
Media Release
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Cellceutix to Pursue Significant Conjuctivitis and Kerititis Ocular Markets With Novel Antibiotic Brilacidin.
Media Release
Cellceutix Plans for Entry in Diabetic Foot Wound and Ulcer Market.
Media Release
Cellceutix Provides Updates on Clinical Trials and Developments of Its Anti-Cancer, Anti-Psoriasis, and
Antibiotic Compounds.
Media Release
Innovation Pharmaceuticals Collaborating with Regional Biocontainment Lab on Grant Application to
Research Brilacidin as a Pan-Coronavirus Therapeutic.
Media Release
Innovation Pharmaceuticals Secures Up to $10 Million in Additional Financing to Advance Clinical Pipeline.
Media Release
Cellceutix Enters Into a $30 Million Common Stock Purchase Agreement.
Media Release
PolyMedix Announces Proposed Public Offering of Common Stock.
Media Release
PolyMedix Awarded Therapeutic Discovery Credits for Two Lead Programs.
Media Release
PolyMedix Antibiotic Studies Accepted for Presentation at ICAAC.
Media Release
PolyMedix Secures $14 Million Credit Facility and Files Shelf Registration Statement.
Media Release
Innovation Pharmaceuticals Receives New Patent for Compounds for Use in Treatment of Oral Mucositis.
Media Release
Innovation Pharmaceuticals Receives New Brilacidin Patent, Further Expanding Intellectual Property Estate.
Media Release
Innovation Pharmaceuticals Expands Brilacidin Patent Portfolio.
Media Release
Innovation Pharmaceuticals Granted European Patent for Brilacidin in the Prevention of Oral Mucositis.
Media Release
PolyMedix Receives U.S. Patent Protection for Licensed Computational Methods to Design Antimicrobial
Polymers.
Media Release
PolyMedix Receives Issuance of Patent for Antimicrobial Compounds.
Media Release
Innovation Pharmaceuticals Plans for Phase 2 Trial of New Treatment for Ulcerative Colitis.
Media Release
Innovation Pharmaceuticals Brilacidin as a Novel Inhibitor of Phosphodiesterase 4 (PDE4) Supports its
Potential to Treat Autoimmune and Inflammatory Diseases; Company Invited to Present at Upcoming Crohns
& Colitis Foundation Conference.
Media Release
Innovation Pharmaceuticals Provides Corporate Update Highlighting Upcoming Milestones and Events.
Media Release
Innovation Pharmaceuticals Phase 2 PoC Trial for Inflammatory Bowel Disease Achieves Induction of
Remission in a Majority of Patients Treated with Brilacidin.
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Media Release
Innovation Pharmaceuticals Announces Clinical Development Plans for Oral Brilacidin for Inflammatory
Bowel Disease.
Media Release
PolyMedix Announces Positive Results From Phase 2 Clinical Trial With PMX-30063 First-in-Class
Defensin-Mimetic Antibiotic.
Media Release
PolyMedix's PMX-30063 First in Class Defensin-Mimetic Antibiotic Demonstrates Activity Against
Drug-Resistant Bacterial Pathogens.
Media Release
PolyMedix Announces Encouraging Interim Results From Multinational Phase 2 Clinical Trial With
PMX-30063 Defensin-Mimetic Antibiotic.
Media Release
Korczak B, McAllister E. A phase 1 trial to evaluate the tolerability, safety and pharmacokinetics of multi-dose
intravenous regiments of PMX30063. 21st-ECCMID-27th-ICC-2011 2011; abstr. N/A.
Available from: URL: http://www.eccmid-icc2011.org
PolyMedix Defensin-Mimetic Antibiotic PMX-30063 Active Against NDM-1 Drug-Resistant Bacteria.
Media Release
Pulse ME. Efficacy of PMX30063 in Experimental Staphylococcal Skin and Skin Structure Infection Models.
49th-ICAAC 2009; abstr. F1-2013.
Available from: URL: http://www.icaac.org
Scott R W. Pharmacokinetic-Pharmacodynamic Relationships for PMX30063 in the Mouse Thigh Burden
Model. 49th-ICAAC 2009; abstr. F1-2014.
Available from: URL: http://www.icaac.org
Scott RW, Liu D, Xu Y, Clements D, DeGrado WF. In vitro antimicrobial activities of a novel host defence
protein mimetic, PMX30063, against multiple isolates of Saphylococci with defined susceptibility phenotypes.
48-ICAAC-46-IDSA-2008 2008;328 (plus poster) abstr. F1-3993.
Available from: URL: http://www.icaacidsa2008.org
Scott RW, Korczak B, Clements D, Xu Y, Liu D. In vivo efficacy and safety of a novel host defecse protein
mimetic, PMX30063: a candidate IV agent to treat Staphylococcal infections. 48-ICAAC-46-IDSA-2008
2008;328 (plus poster) abstr. F1-3994.
Available from: URL: http://www.icaacidsa2008.org
Innovation Pharmaceuticals Clinical Trial of Oral Brilacidin in Ulcerative Colitis Program Expected to
Commence in December; Top-Line Data in Q1 2020.
Media Release
Cellceutix Releases Confidence Interval Statistics Showing Clinical Success Rates for Brilacidin in Treatment
of ABSSSI.
Media Release
Innovation Pharmaceuticals Plans for Clinical Trial of Oral Brilacidin for Ulcerative Colitis Program in 4th
Quarter 2019.
Media Release
PolyMedix Presents PMX-30063 Antibiotic Data at the 49th Annual Meeting of the Infectious Disease Society
of America.
Media Release
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