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I like your analogy for the Israeli company!
It would take a miracle to expect
a price rebound.
Miracles have happened in the Holy
Land, but that was a very very long
time ago.
midas,
You took the words right out of my mouth! I've been holding Redhill since January, 2015...at $14.94 per share! I had always believed that someday they would be successful. I guess I just got suckered into believing all their hype, false promises, and exaggerated quarterly reports. I'll probably sell this later in the year, as a loss, to balance out (taxes) the gains on another stock that's doing well.
Woe is me!
I am very close to losing
hope altogether.
Any chance if this coming back to life?
RedHill Biopharma COVID treatment reduces severe symptoms in mid-stage trial
Mar. 01, 2022 11:27 AM ETRedHill Biopharma Ltd. (RDHL)
By: Jonathan Block, SA News Editor
RedHill Biopharma's (NASDAQ:RDHL) oral COVID-19 treatment RHB-107 (upamostat) demonstrated a significant reduction in new severe symptoms in non-hospitalized, symptomatic COVID patients in a phase 2 study.
In the study, no patients on RHB-107 were hospitalized, compared to 15% on placebo.
Just 2.4% of patients on upamostat developed new severe symptoms, compared to 20% in the placebo arm.
RHB-107 also demonstrated a favorable safety and tolerability profile.
Last month, RedHill (RDHL) reported that another oral COVID-19 therapy, opaganib, "significantly reduced" death among hospitalized patients.
RedHill Announces Positive Phase 2 Study Results with Oral RHB-107 in Non-Hospitalized COVID-19
https://finance.yahoo.com/news/redhill-announces-positive-phase-2-140000003.html
Phase 2 part of Phase 2/3 study of once-daily oral RHB-107 in symptomatic COVID-19 successfully met the study's primary endpoint showing good safety and tolerability and highly promising efficacy results
100% reduction in hospitalization due to COVID-19 with zero patients (0/41) on the RHB-107 arms versus 15% (3/20) hospitalized on the placebo-controlled arm
87.8% reduction in reported new severe COVID-19 symptoms after treatment initiation, with only one patient in the RHB-107 treated group 2.4%, (1/41) versus 20% (4/20) of patients in the placebo-controlled arm)
The most common variant among patients in the study was Delta; RHB-107, a novel, investigational oral antiviral serine protease inhibitor, targeting host rather than viral factors, is expected to maintain effect against emerging viral variants
TEL AVIV, Israel and RALEIGH, N.C., March 1, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced positive top-line results from the Phase 2 part of the Phase 2/3 study of once-daily oral RHB-107 (upamostat)[1] in non-hospitalized symptomatic COVID-19 patients, predominantly conducted in the U.S. (60/61 patients) as well as South Africa.
Although not powered for efficacy assessment, the study showed highly promising efficacy results delivering a 100% reduction in hospitalization due to COVID-19, with zero patients on RHB-107 hospitalized with COVID-19 (0/41) compared to 15% on the placebo-controlled arm requiring hospitalization (3/20) (nominal p-value=0.0317). Furthermore, the study showed an 87.8% reduction in reported new severe COVID-19 symptoms, with only one patient on RHB-107 (2.4%, 1/41) compared to 20% (4/20) of patients on the placebo-controlled arm experiencing new COVID-19 related severe symptoms (nominal p-value=0.036).
The study met its primary outcome measure, demonstrating a favorable safety and tolerability profile of RHB-107. Study arms were well balanced with respect to baseline disease severity, risk factors and vaccination status. Patients were also tested for the specific viral strain (last patient randomized November 12, 2021), with the most common variant being Delta, found in 62.5% of the patients that had next generation sequencing (NGS).
"These very promising efficacy results, achieved despite a small overall sample size, are impressive. Coupling the efficacy results with successfully meeting the primary endpoint of good safety and tolerability and convenient once-daily dosing, positions oral RHB-107 as a potential highly beneficial treatment for COVID-19 outpatients early in the course of disease in order to reduce symptom severity and prevent disease progression and hospitalization. Given the limitations of current options for early treatment of COVID-19, we are excited to progress the development of RHB-107, subject to additional discussions with regulatory authorities," said Terry F. Plasse MD, Medical Director at RedHill. "Equally important is our expectation that RHB-107, with its human cell factor targeting, would maintain its action irrespective of spike protein mutations, thus likely making it a highly desirable variant-agnostic potential treatment option."
The Phase 2/3 multicenter, randomized, double-blind, placebo-controlled, parallel-group study (NCT04723527) with RHB-107 is aimed at evaluating treatment in patients with symptomatic COVID-19 early in the course of the disease, with a once-daily oral treatment that can be prescribed and used in the non-hospitalized patient population. The Phase 2 part of the study was designed to evaluate safety for dose selection and to provide preliminary assessment of parameters to be used for efficacy evaluation in Part B. A total of 61 patients were enrolled in Part A and randomized on a 1:1:1 basis to receive one of two dose levels of RHB-107 or a placebo control.
Next steps for the study will follow data submission and discussion with regulators.
About RHB-107 (upamostat)
RHB-107 is a proprietary, first-in-class, orally-administered antiviral, that targets human serine proteases involved in preparing the spike protein for viral entry into target cells. RHB-107 targets host cell factors involved in preparing the spike protein for viral entry into target cells and is therefore expected to be effective against emerging viral variants with mutations in the spike protein. RHB-107 is being evaluated in a Phase 2/3 study for treatment of patients with symptomatic COVID-19 who do not require inpatient care. RHB-107 has demonstrated strong inhibition of SARS-CoV-2 viral replication in an in vitro human bronchial epithelial cell model. RHB-107 has a strong clinical safety and biodistribution profile, demonstrated in previous clinical studies, including several Phase 1 studies and two Phase 2 studies, demonstrating its clinical safety profile in approximately 200 patients. In addition, RHB-107 inhibits several proteases targeting cancer and inflammatory gastrointestinal disease. RedHill acquired the exclusive worldwide rights to RHB-107, excluding China, Hong Kong, Taiwan and Macao, from Germany's Heidelberg Pharma (FSE: HPHA) (formerly WILEX AG) for all indications.
RedHill Biopharma preliminary Q4 net revenue falls short of estimates
Feb. 17, 2022 10:55 AM ETRedHill Biopharma Ltd. (RDHL)
By: Ravikash, SA News Editor
RedHill Biopharma (RDHL -1.7%) expects Q4 total net revenues to be in the range of $22M to-24M, below the consensus revenue estimate of $24.09M, according to preliminary data.
The company had recorded $21.5M in revenue in Q4 2020.
RedHill expects to have achieved commercial operations breakeven in Q4 and expect profitable commercial operations in 2022 (both non-GAAP EBITDA).
As of Dec. 31, 2021 cash balance was $54.2M, compared to $45.9M as of Dec. 31, 2020.
Record Talicia quarterly new prescriptions, increase of 26.5% vs. Q3 2021, and 78.4% vs. Q4 2020.
Movantik new prescriptions grew by 2.4% vs. Q3 2021 and 4.5% vs. Q4 2020
Substantial decrease in operational and development expenses following implementation of a cost-efficiency plan.
"Strong sales growth momentum in the face of the persistent pandemic environment, coupled with strengthening our salesforce through internal realignment to include 120 customer-facing sales professionals, disciplined cost-control measures and the potential addition of products synergistic to our existing commercial basket, are planned to bring us closer to commercial operations profitability in 2022," said RedHill's CEO Dror Ben-Asher.
The company intends to announce its Q4 and full year 2021 results in the coming weeks.
It seems that only a D-9 can
do something to move s/p up.
So why aren’t we much higher?
Where should the price be?
RedHill Biopharma Announces Record Quarterly Revenues and First Commercial Operations Breakeven
https://finance.yahoo.com/news/redhill-biopharma-announces-record-quarterly-143000661.html
TEL AVIV, Israel and RALEIGH, N.C., Feb. 17, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today provided a business update for the fourth quarter of 2021, including certain estimated unaudited preliminary financial data.
Dror Ben-Asher, RedHill's Chief Executive Officer, said: "Strong sales growth momentum in the face of the persistent pandemic environment, coupled with strengthening our salesforce through internal realignment to include 120 customer-facing sales professionals, disciplined cost-control measures and the potential addition of products synergistic to our existing commercial basket, are planned to bring us closer to commercial operations profitability in 2022. In parallel, our compact R&D team continues to display tremendous creativity and drive in progressing RedHill's robust late clinical-stage pipeline. In particular, extensive discussions are ongoing with regulators in multiple countries regarding potential pathways to approval of orally-administered opaganib, likely the first novel oral drug candidate to have shown an improvement in viral clearance in severe hospitalized COVID-19 patients."
The Company intends to announce its audited fourth quarter and full year 2021 results in the coming weeks. The preliminary financial data ranges described herein have not been audited and are subject to adjustment based on the Company's completion of year-end financial close processes.
Added Positions: BMY, OLLI, NEM, RDS.B, CM, PYPL, SU, TKC, CP, RDHL, GOOG, MA, V, EWZ, DIS, FTS, CRM, AGRO,
https://finance.yahoo.com/news/claret-asset-management-corp-buys-183813521.html
RedHill Biopharma says oral COVID-19 therapy lowered mortality in hospitalized patients
Feb. 07, 2022 10:59 AM ETRedHill Biopharma Ltd. (RDHL)
By: Dulan Lokuwithana, SA News Editor
Announcing data from a Phase 2/3 trial for its COVID-19 therapy opaganib, RedHill Biopharma (RDHL -2.4%) said Monday that the oral treatment “significantly reduced” death among hospitalized patients who had previously received standard-of-care (SOC).
According to the prespecified mortality analysis, among those who were receiving SOC of remdesivir and corticosteroids, opaganib treated patients were found to have a 70.2% mortality benefit. The second prespecified analysis indicated that the experimental therapy led to a significant 34% benefit in time to recovery.
The company is planning to seek potential regulatory authorizations for the treatment in certain countries in H1 2022, and the regulatory submissions have already begun in the U.S., Europe, the U.K., and additional countries.
In September, RedHill (NASDAQ:RDHL) said that the global Phase 2/3 study for opaganib did not meet the primary endpoint in hospitalized patients with severe COVID-19 pneumonia.
RedHill Biopharma's Oral Opaganib Reduces Mortality by 70% Given on Top of Remdesivir and Corticosteroids in Severe COVID-19
RedHill Biopharma's Oral Opaganib Reduces Mortality by 70% Given on Top of Remdesivir and Corticosteroids in Severe COVID-19
Updates on Regulatory Discussions and Plans in Multiple Countries
Prespecified analysis of Phase 2/3 opaganib data in severe COVID-19 patients showed a significant, 70.2% mortality benefit with opaganib by Day 42 when given on top of the best available standard-of-care (SoC), remdesivir and corticosteroids (6.98% mortality in the opaganib arm versus 23.4% for placebo, p-value=0.034)
--
A second prespecified analysis showed that opaganib also delivered a significant 34% benefit in 'time to recovery by Day 14', with 37.4% of opaganib-treated patients reaching this event versus 27.9% of patients treated with placebo + SoC (p-value=0.013)--
These additional prespecified mortality and recovery analyses, along with previously announced data showing opaganib's improved median time to SARS-CoV-2 viral RNA clearance, further strengthen the positive outcomes in the Phase 2/3 study post-hoc analysis. All data is being shared with regulators
--
Opaganib data submissions initiated in Q4/21, initial guidance on potential path to approval received from the EU's EMA, the U.S. FDA, UK's MHRA and others, discussions ongoing
--
Based on regulatory feedback and external advice received from other territories, potential emergency and marketing authorization applications planned in H1/2022
https://finance.yahoo.com/news/redhill-biopharmas-oral-opaganib-reduces-151500444.html
TEL AVIV, Israel and RALEIGH, NC, February 7, 2022 -- InvestorsHub NewsWire -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced results from two recently completed prespecified analyses from the oral opaganib (ABC294640)[1] Phase 2/3 study in hospitalized severe COVID-19. The first analysis showed that opaganib significantly reduced mortality when given to patients who received remdesivir and corticosteroids, the best available standard-of-care (SoC) for hospitalized patients. A second analysis further showed that opaganib delivered a significant benefit in time to recovery, defined as achieving a score of 1 or less on the WHO Ordinal Scale by Day 14. The Company is advancing regulatory discussions in multiple countries, with potential emergency and marketing authorization applications being planned for certain countries in the first half of 2022.
The prespecified mortality analysis, undertaken for all patients from the Phase 2/3 study who were receiving remdesivir and corticosteroids at baseline, demonstrated a significant 70.2% mortality benefit for opaganib-treated patients, with a mortality rate of 6.98% (n=3/43) for the opaganib arm + SoC versus 23.4% (n=11/47) for placebo + SoC by Day 42 (p-value=0.034).
The second prespecified analysis showed opaganib delivered a significant 34% benefit in time to recovery, defined as achieving a score of 1 or less on the WHO Ordinal Scale by Day 14, with 37.4% of opaganib-treated patients (n=86/230) reaching this event versus 27.9% of patients (n=65/233) treated with placebo + SoC (p-value=0.013, Hazard Ratio 1.49)
"These prespecified analyses, along with the recent data showing opaganib's improved median time to viral RNA clearance, provide strong support for the promising results observed in the Phase 2/3 study post-hoc analysis. Oral opaganib has now shown an ability to reduce deaths, speed up recovery and clear viral RNA, all with a safety and tolerability profile similar to placebo. Strikingly, opaganib has delivered these benefits over and above the very best level of current standard-of-care, with patients receiving both remdesivir and corticosteroids," said Dr. Mark Levitt, RedHill's Chief Scientific Officer. "The hospitalized moderate to severe COVID-19 patient group is estimated to represent more than 50% of all hospitalized COVID-19 cases and growing. The prevalence of Omicron, new emerging variants, loss of efficacy of existing drugs against such variants and the difficulty in stopping COVID-19 early enough in its course, despite the availability of new drugs, all point very clearly to the urgent need for new, preferably orally-administered, therapeutic options, unaffected by spike protein mutations, for this underserved and substantial patient population."
Regulatory progress continues to be made, with opaganib data submissions initiated in the fourth quarter of 2021 in the U.S., Europe, UK and additional countries. Discussions remain ongoing and initial guidance on a confirmatory study and potential path to approval has been received from the EU's EMA, the U.S. FDA, UK's MHRA and others. Based on regulatory feedback from other territories and external advice received, the Company is also planning potential emergency and marketing authorization applications in certain such countries in the first half of 2022.
Oral opaganib was studied in a global Phase 2/3 study in hospitalized patients with severe COVID-19 pneumonia (NCT04467840). In a prespecified analysis of all Phase 2/3 study patients with a positive PCR at screening[2] opaganib improved the median time to viral RNA clearance by at least 4 days, achieving viral RNA clearance in a median of 10 days, while the median for clearance was not reached by the end of 14-days treatment in the placebo arm (Hazard Ratio 1.34; nominal p-value=0.043, N=437/463). Additionally, results from a post-hoc analysis of data from 251 study participants requiring a Fraction of inspired Oxygen (FiO2) up to and including 60% at baseline (54% of the study participants) demonstrated that treatment with oral opaganib resulted in a 62% reduction in mortality as well as improved outcomes in time to room air, median time to hospital discharge, and likelihood of intubation and mechanical ventilation in this large group of hospitalized, moderately severe COVID-19 patients.
About Opaganib (ABC294640)
Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, with proposed dual anti-inflammatory and antiviral activity. Opaganib is host-targeted and is expected to be effective against emerging viral variants, having already demonstrated inhibition against variants of concern, including Delta. Opaganib has also shown anticancer activity and positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.
Opaganib previously delivered promising U.S. Phase 2 data in patients with moderate to severe COVID-19, submitted for peer review and recently published in medRxiv.
Opaganib has also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Patient accrual, treatment and analysis in this study are ongoing.
Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, inhibiting viral replication of the original SARS-CoV-2 and variants tested to date in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies have demonstrated opaganib's potential to decrease renal fibrosis, have shown decreased fatality rates from influenza virus infection, and amelioration of bacteria-induced pneumonia lung injury with reduced levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids[3].
The ongoing clinical studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.
With EUA approval in Colombia, i would
expect an immediate 50% spike in price.
Should other regions follow suit, i
expect sp to exceed $10.
Huge sp bonanza should the US or UK
approval/s is/are achieved, and naturally
some mega partnership would obvious occur.
In short, my hopes for my breaking even
are high!
Big if tho.......
Fingers crossed
Interesting…if approved how high do you see the stock price going?
Kukbo Co., Ltd., a KOSPI-listed company, announced on the 28th that the US/Israel biotechnology company RedHill Biopharma's oral treatment for moderate/severe corona virus Opaganib will be approved for emergency use in the first half of the year.
Currently, the EUA (Emergency Use Authorization) procedure is the fastest in Colombia and there is very positive feedback, so emergency use approval is scheduled for mid-February. said. Additional data have been submitted to the US and EU, and it is known that the emergency approval process will soon begin through feedback from regulators.
Kukbo acquired a stake in Red Hill in November of last year and distributes oral COVID-19 treatments (Opaganib, RHB-107 (Upamostat)) and Talica® developed by Red Hill in Korea as well as major Asian regions. In the first quarter of this year, it has been given the right to preferential negotiation of the copyright contract, and signed a business performance service contract for Opaganib with LSK Global Pharma Service, a leading domestic clinical contract company (CRO) in December. Following the NDA Submission, the domestic emergency use approval procedure is in progress, and attention is focused on the result.
Red Hill's Opaganib is the only oral corona treatment that can treat severe and moderate COVID-19 patients. Compared to patients receiving standard treatment (remdesivir or dexamethasone), Red Hill's Opaganib reduced mortality in severe patients by 62%, It has published improved clinical results over time, and it is less burdensome and less burdensome to take compared to Pfizer's 'Paxrovid', which requires taking 30 tablets for 5 days by taking 2 tablets (1 tablet at a time) for 7 to 14 days. It is also known to have price competitiveness and is expected to attract attention.
In addition, Opaganib has demonstrated dual anti-inflammatory and antiviral activity targeting palliative cellular components, and as a sphingosine kinase-2 (SK2) selective inhibitor, it has been demonstrated to potentially minimize the possibility of viral resistance, thereby demonstrating superiority in the basal aspect. It has been proven, and it has been proven that the individual combination of Opaganib and RHB-107 (Upamostat) has a potential antitumor effect and antitumor effect on patients with cholangiocarcinoma, and has received a patent application from the US Patent and Trademark Office (USPTO).
Source: Global Economic Daily (http://www.getnews.co.kr)
Good News a-coming?
Kukbo announced that RedHill Biopharma, an Israeli biotechnology
company in the United States and Israel, will receive emergency
use approval for Opaganib, a moderate-to-severe oral treatment for
COVID-19, in Colombia and Russia in the first half of the year.
Source:Stocktwits
Sold Out: BWMX, CLLS, DBVT, RDHL
https://finance.yahoo.com/news/henry-james-international-management-inc-183826636.html
I was pleasantly surprised RDHL was
up yesterday when the XBI index was
3.5% down.
To your question: I am still in,
reflecting my hopes RDHL will recover.
Any hope for this thing to come back?
Re RDHL
Fully agreed.
Re ORMP
Liquidated 100%. At least covered some
of my RDHL losses. Not enough tho.
Re BLRX
Some hopes there. Not too long a wait
to find out.
This co really fxxxed up royally.
Hope ORMP does not go the same way
RedHill says oral COVID-19 therapy improved viral clearance in severely ill patients
Jan. 13, 2022 11:18 AM ETRedHill Biopharma Ltd. (RDHL)
By: Dulan Lokuwithana, SA News Editor
RedHill Biopharma (NASDAQ:RDHL) announced that its oral COVID-19 therapy opaganib “significantly” improved viral clearance in a Phase 2/3 trial involving severely ill hospitalized patients with the disease.
In patients with positive PCR at screening, the median time to viral RNA clearance with opaganib improved by at least four days. In the opaganib arm, the median for viral clearance was ten days, while the placebo arm did not reach the clearance median by the end of the 14-day treatment.
(Hazard Ratio 1.34; nominal p-value=0.043, N=437/463).
With a median of 11-days from the onset of symptoms, the patient group was much further advanced than the mild-to-moderate outpatients for whom the currently FDA authorized COVID-19 therapies are indicated.
In July, RedHill (RDHL) announced the completion of treatment and follow-up in the 475-patient Phase 2/3 study for opaganib.
RedHill Biopharma's Oral Opaganib Significantly Improves Viral Clearance in Phase 2/3 Study in Severely Ill Hospitalized COVID-19 Patients
https://finance.yahoo.com/news/redhill-biopharmas-oral-opaganib-significantly-153500501.html
- In a prespecified analysis of all Phase 2/3 study patients with positive PCR at screening, opaganib improved the median time to viral RNA clearance by at least 4 days; Median of 10 days for viral clearance in the opaganib arm vs. clearance median not reached by end of 14-day treatment in placebo arm (Hazard Ratio 1.34; nominal p-value=0.043, N=437/463)
- Opaganib is the first oral novel drug candidate to show improved viral RNA clearance in patients with severe COVID-19 pneumonia; Provides clinical evidence supporting opaganib's potential antiviral activity
- Results achieved in a severely ill hospitalized patient population with a median of 11-days from onset of symptoms - a patient population much further advanced than mild-moderate outpatients with less than 5 days from symptom onset, for which oral anti-viral medications have recently been approved
- Results add to opaganib's 62% reduction in mortality seen in a post-hoc analysis of the Phase 2/3 study and are being provided to regulators as part of ongoing discussions on potential pathways to approval in multiple countries
TEL AVIV, Israel and RALEIGH, N.C., Jan. 13, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced new data from a prespecified analysis of all oral opaganib's[1] Phase 2/3 study patients with positive PCR at screening, demonstrating that opaganib improved the median time to viral RNA clearance by at least 4 days. Treatment with opaganib resulted in viral RNA clearance in a median of 10 days while the median for clearance in the placebo arm was not reached by the end of 14-days treatment for placebo (Hazard Ratio 1.34; nominal p-value=0.043, N=437/463).
"Opaganib is the first oral novel drug candidate to demonstrate SARS-CoV-2 viral RNA clearance in hospitalized patients with severe COVID-19 pneumonia. It also provides the first clinical demonstration of opaganib's potential antiviral activity, supporting the 62% reduction in mortality seen in the post-hoc analysis of a large subset of patients from the Phase 2/3 study and confirming the viral inhibition observed in preclinical testing against Delta and other variants," said Dr. Mark Levitt, RedHill's Chief Scientific Officer. "It is important to note that these results were achieved in a severely ill hospitalized patient population and following an 11-day median time from onset of symptoms - an entirely different patient population from the mild-moderate outpatients with less than 5 days from symptom onset, for whom oral antivirals have been recently approved. It is also important to keep in mind that as opaganib's proposed mechanism of action targets a host factor, its activity is not expected to be affected by mutations in the spike protein emerging with new viral variants, including Omicron."
Opaganib was studied in a global Phase 2/3 study in hospitalized patients with severe COVID-19 pneumonia (NCT04467840) with positive PCRs at screening obtained for 437 out of 463 patients (the remaining patients could not be included in this prespecified analysis due to lack of PCR results at screening). Results from a post-hoc analysis of data from 251 study participants requiring a Fraction of inspired Oxygen (FiO2) up to and including 60% at baseline (54% of the study participants) demonstrated that treatment with oral opaganib resulted in a 62% reduction in mortality as well as improved outcomes in time to room air, median time to hospital discharge, and likelihood of intubation and mechanical ventilation in this large group of hospitalized, moderately severe COVID-19 patients.
RedHill is vigorously pursuing the development program for opaganib and is in ongoing discussions with multiple regulatory agencies regarding potential pathways to approval.
About Opaganib (ABC294640)
Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, with proposed dual anti-inflammatory and antiviral activity. Opaganib is host-targeted and is expected to be effective against emerging viral variants, having already demonstrated strong inhibition against variants of concern, including Delta. Opaganib has also shown anticancer activity and positive preclinical results in renal fibrosis, and also has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.
Opaganib previously delivered positive U.S. Phase 2 data in patients with moderate to severe COVID-19, submitted for peer review and recently published in medRxiv.
Opaganib has also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Patient accrual, treatment and analysis in this study are ongoing.
Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, inhibiting viral replication of the original SARS-CoV-2 and variants tested to date in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies have demonstrated opaganib's potential to decrease renal fibrosis, have shown decreased fatality rates from influenza virus infection, and amelioration of bacteria-induced pneumonia lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids[2].
The ongoing clinical studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.
RedHill Biopharma and Gaelan Medical Enter Into License Agreement for Talicia® for the United Arab Emirates
https://finance.yahoo.com/news/redhill-biopharma-gaelan-medical-enter-141500473.html
Gaelan Medical to pay RedHill $2 million upfront plus potential regulatory and sales milestones and tiered royalties on net sales, for the exclusive rights in the United Arab Emirates to Talicia®
Talicia is a U.S. FDA-approved treatment for H. pylori, a bacterial infection that affects more than 50% of the world's adult population representing significant unmet need
RALEIGH, N.C. and TEL-AVIV, Israel, Jan. 6, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announced that it has entered into an exclusive license agreement with Gaelan Medical Trade LLC ("Gaelan Medical"), a wholly owned subsidiary of the Ghassan Aboud Group (GAG), for Talicia® (omeprazole magnesium, amoxicillin and rifabutin)[1], an H. pylori therapy, in the United Arab Emirates (UAE).
Under the terms of the agreement, RedHill will receive an upfront payment of $2 million and is eligible for additional milestone payments as well as tiered royalties up to mid-teens on net sales of Talicia in the UAE. Gaelan Medical will receive the exclusive rights to commercialize Talicia in the UAE, as well as a right of first refusal to commercialize Talicia in the Gulf Cooperation Council region (Saudi Arabia, Kuwait, Qatar, Bahrain and Oman) for a pre-determined period.
"We are delighted to partner with Gaelen Medical to help bring Talicia to H. pylori patients in the UAE and potentially other territories in the region," said Dror Ben-Asher, RedHill's CEO. "This partnership is particularly important given that H. pylori, a major public health concern, impacts up to 84% of the population in the region[2] and is one of the strongest risk factors for gastric cancer, leading to a recent regional clinical consensus meeting calling for eradication therapy to be offered to all individuals infected with H. pylori[3]. We are seeing rapid growth of Talicia in the U.S. in light of the alarming failure rates of clarithromycin-based therapies and growing physician awareness of the need for highly effective first-line H. pylori therapy. We continue to explore with potential partners the expansion of Talicia's reach into additional ex-U.S. territories."
"H. pylori can cause extensive damage if not properly eradicated first-time and there is considerable need for a therapy like Talicia in the UAE, where 41% of the population[4] is affected and have limited options for treatment," said Ghassan Aboud, Chairman of GAG. "Talicia would become the first approved combination product in the UAE specifically designed to treat H. pylori, and we are excited to be partnering with RedHill and at the prospect of realizing Talicia's potential to help patients with H. pylori infection in the UAE and potentially other territories in the region."
About Talicia®
Talicia® is the only rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria seen with other antibiotics. The high rates of H. pylori resistance to clarithromycin have led to significant rates of treatment failure with clarithromycin-based therapies and are a strong public health concern, as highlighted by the ACG, FDA and the World Health Organization (WHO) in recent years.
Talicia® is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia® was approved by the U.S. FDA for the treatment of H. pylori infection in adults. In the pivotal Phase 3 study, Talicia® demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). Minimal to zero resistance to rifabutin, a key component of Talicia®, was detected in RedHill's pivotal Phase 3 study. Further, in an analysis of data from this study, it was observed that subjects who were confirmed adherent[5] to their therapy had response rates of 90.3% in the Talicia® arm vs. 64.7% in the active comparator arm[6].
Talicia® is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034 with additional patents and applications pending and granted in various territories worldwide.
RedHill Biopharma: Looking At An Unexciting Dead-End
Dec. 30, 2021 3:32 PM ETRedHill Biopharma Ltd. (RDHL)
Summary
RDHL has had many avatars, and the latest one has taken the stock down considerably.
There does not seem to be a defining nature in RDHL's business.
I will avoid this for now.
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About RedHill Biopharma (RDHL), I said the following exactly a year ago - "a somewhat boring, long-term, relatively risk-free, low-headache investment for investors." What happened to RedHill to take it down 70% since I wrote that?
RedHill was once a supplier of legacy products no one wanted. These products didn't sell too well, and the business was discontinued. In 2017, it acquired a pair of products from AstraZeneca (AZN) and privately held Cosmo, and started generating a good amount of revenue. Then, during the pandemic, RedHill rediscovered itself. It began developing reformulated old products, or old products with new delivery methods. Talicia was the first product of this kind that got approved. A combination of omeprazole magnesium, amoxicillin and rifabutin, Talicia treats Helicobacter pylori infection in adults. It is supposed to have a pretty large target market. Their next product in the pipeline was RHB-104 in Crohn's Disease, with positive phase 3 data in hand.
This was the state of RDHL in December last year when I covered it. They were a little low on cash, with about $50mn in hand at that time. So I was expecting a dilution, but I was not expecting a 70% depreciation in shareholder value in one year for what I had said was a staid, boring, low-risk stock.
Going through the news for the previous year, there are mainly two things that took the stock down. One of these is dilution. The other was euphoria surrounding covid-19, which was pushing the stock up until bad news came, and it collapsed. The company's covid candidate is opaganib, which began by showing promising results in animal studies, where it demonstrated a reduction of thrombosis in acute respiratory distress syndrome or ARDS in animal models. In December 2020, the company announced positive top-line safety and efficacy data from a Phase 2 study with opaganib in 40 patients with COVID-19 pneumonia. This was followed by a number of Data Safety Monitoring Board (DSMB) recommendations to continue the Phase 2/3 study with orally-administered opaganib in patients hospitalized with severe COVID-19 trial, as planned. I note four of these DSMB reviews and recommendations.
Then in August the stock jumped hugely after preliminary results of a new preclinical study showed "strong inhibition by opaganib (ABC294640) of Delta variant replication while maintaining cell viability at relevant concentrations." However, that rally didn't last. This was just a preclinical study, however, in the real world phase 2/3 study, opaganib disappointed. In late August, early data from this study showed that ??opaganib treatment led to patients requiring less oxygen and earlier hospital discharge compared to those on placebo. However, by mid-September, topline data showed that the trial failed to reach statistical significance despite showing an efficacy trend. Key highlights:
Preliminary top-line data showed that the study did not meet its primary endpoint. Analysis of the study efficacy endpoints did show trends in favor of the opaganib arm vs. placebo across multiple endpoints, including the primary endpoint, despite not achieving statistical significance.
Top-line safety data showed good tolerability of opaganib, with balanced adverse events between the study arms. These findings, together with preliminary analysis pointing to increased benefit in a subset of patients requiring less oxygen, could support the potential utilization of opaganib in earlier stages of the disease and are in line with the previously announced results from the U.S. Phase 2 study and the previously observed antiviral activity of opaganib.
The stock had started falling ever since the release of data on the medRxiv journal in late August. On this topline data failure, the stock price nearly halved. The company did try to find benefits "earlier in the course of the disease," however, the market seemed not to be buying that.
Going back to dilution, RDHL stock fell badly in November after the Israeli company announced an offering of American Depositary Shares. The stock fell 25% after announcing 4.7 million ADS valued at $15.5mn. There's no doubt they needed funds, but they announced a dilution from a position of weakness - after poor performance in the phase 2 trial. The market did not appreciate that. While RDHL has a solid business in its Moventik and legacy franchise, most of the euphoria surrounding the stock was from the covid-19 study. The failure of that trial took the stock down, and then there was the dilution - the stock hasn't recovered since, and I do not expect a quick recovery anytime soon.
Financials
RDHL has a market cap of $138mn and a cash balance of $51mn as of the September quarter. They also have a $80mn debt balance. Since then, they have raised an additional $15.5mn, but Research and Development expenses were $5.8 million for the third quarter of 2021, and SG&E was $24mn, so if that trend has continued, their current cash position would be somewhere in the range of $45mn.
The company, being an ADR, does not have insider transaction data available in the US. However, they did make two separate announcements about insider purchases. First was in September and mid-Oct, when the company's board and management together purchased 180,000 ADS. Then, just this month, insiders purchased another 66,000 ADS in the open market.
Besides, the company also raised more funds through a collaboration:
In November 2021, the Company announced that it had entered into a strategic agreement with Kukbo Co. Ltd., a South Korean corporation, for the sale of RedHill's American Depositary Shares (ADSs) in a private placement of up to $10 million, of which the first tranche of $5 million has been paid. As part of the agreement, the Company granted Kukbo a six month right of first offer for a license with respect to one or more of opaganib, RHB-107 (upamostat) and Talicia® for South Korea and other Asian territories.
Bottomline
RDHL is a complicated company with too many things going on at the same time, making it difficult for investors to figure out where to focus. They have their legacy products, they have the covid-19 program, and they have the rest of their pipeline. Taking all of these together, I think it is kind of dull that the market values it so low. RDHL looks like an aimless business with no defining characteristic, and what little it had in stability last year has been lost to the effort with covid-19 therapy. Right now, RDHL looks like a cul-de sac.
This article was written by
Avisol Capital Partners profile picture
Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
Ascendiant Capital Adjusts Price Target on Redhill Biopharma
to $19 From $26, Maintains Buy Rating
LOL i wish. I'll take 50% happily!
https://www.marketscreener.com/quote/stock/REDHILL-BIOPHARMA-LTD-12243230/news/Ascendiant-Capital-Adjusts-Price-Target-on-Redhill-Biopharma-to-19-From-26-Maintains-Buy-Rating-37425993/
Life Sciences Companies Investor Presentations Now Available for On-Demand Viewing
https://finance.yahoo.com/news/life-sciences-companies-investor-presentations-133500214.html
Mon, December 20, 2021, 3:35 PM
Individual and institutional investors as well as advisors are invited to log-on to VirtualInvestorConferences.com to view presentations
NEW YORK, Dec. 20, 2021 /PRNewswire/ -- Virtual Investor Conferences, the leading proprietary investor conference series, today announced that the presentations from the December 16th Life Sciences Virtual Investor Conference are now available for on-demand viewing.
This virtual event showcased live company presentations and interactive discussions focused on the life sciences industry. The company presentations will be available 24/7 for 90 days. Investors, advisors, and analysts may download shareholder materials from the company's "virtual trade booth".
REGISTER OR LOGIN NOW AT: https://bit.ly/3yxak8A
Participating Companies:
Presenting Company
Ticker(s)
RedHill Biopharma Ltd.
There cannot be anything new - they will come with same 70 page deck
Anyone listen? Anything new? Is a replay available?
RedHill Biopharma Announces Additional Insider Buying
Wed, December 15, 2021, 4:15 PM
https://investorshub.advfn.com/secure/post_new.aspx?board_id=26290
RALEIGH, N.C. and TEL-AVIV, Israel, Dec. 15, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that members of its board of directors and senior management, including the Company's Chairman & CEO, Mr. Dror Ben-Asher, collectively purchased approximately an additional 66,000 American Depositary Shares (ADSs) of RedHill since mid-October, in open-market transactions.
Well, it was good while it
lasted, about 30 seconds.
Virtual Conference for Life Sciences Companies Broadcast Live December 16th
Tue, December 14, 2021,
Company executives will share corporate vision and answer audience questions at VirtualInvestorConferences.com
NEW YORK, Dec. 14, 2021 /CNW/ - Virtual Investor Conferences, the leading proprietary investor conference series, announced the agenda for its quarterly event for public and private companies, investors, and industry professionals from around the world. This day-long virtual event will showcase live company presentations and interactive discussions focused on the life sciences industry.
Individual investors, institutional investors, advisors, and analysts are invited to attend. The program opens at 9:15 AM ET on Thursday, December 16th with the first live webcast at 9:30 AM ET.
REGISTER NOW AT: https://bit.ly/3Go96iH
It is recommended that investors pre-register and run the online system check to expedite participation and receive event updates. There is no cost to log-in, attend the live presentations or ask questions.
"We are delighted to highlight today's innovators from the life science sector," said Jason Paltrowitz, Executive Vice President of Corporate Services at OTC Markets Group. "Our Virtual Investor Conferences continue to provide an efficient platform and unique opportunity for these companies to engage to a broader investor base and communicate their strategies."
Agenda and presenting companies:
Eastern
Time (ET)
Presenting Company
Ticker(s)
9:30 AM
RedHill Biopharma Ltd.
(Nasdaq: RDHL)
10:00 AM
RespireRx Pharmaceuticals Inc.
(OTCQB: RSPI)
10:30 AM
Relief Therapeutics Holdings SA
(OTCQB: RLFTF | SIX: RLF)
11:00 AM
VolitionRx Limited
(NYSE AMERICAN: VNRX)
11:30 AM
Mind Cure Health Inc.
(OTCQX: MCURF | CSE: MCUR)
12:00 PM
Alpha Cognition, Inc.
(OTCQB: ACOGF | TSX-V: ACOG)
12:30 PM
Emmaus Life Sciences, Inc
(OTCQX: EMMA)
1:00 PM
Hemostemix Inc.
(OTCQB: HMTXF | TSX-V: HEM)
1:30 PM
Jack Nathan Medical Corp.
(OTCQB: JNHMF | TSX-V: JNH)
2:00 PM
ReShape Lifesciences Inc.
(NASDAQ: RSLS)
2:30 PM
Else Nutrition Holdings Inc.
(OTCQX: BABYF | TSX-V: JNH)
3:00 PM
Salarius Pharmaceuticals, Inc.
(Nasdaq: SLRX)
To facilitate investor relations scheduling and to view a complete calendar of Virtual Investor Conferences, please visit www.virtualinvestorconferences.com.
3.4900 +0.63 (+22.03%)
Pre-Market: 04:44AM EST
RDHL struck Gold?
You are most welcome Scrapiron,
hopefully we will get one day
properly rewarded!
Thanks for keeping us up to date!
RedHill Biopharma's Talicia Recommended For H. Pylori Infection
Vandana Singh
https://finance.yahoo.com/news/redhill-biopharmas-talicia-recommended-h-180528715.html
Thu, December 9, 2021, 8:05 PM
RedHill Biopharma Ltd (NASDAQ: RDHL) has announced the publication of a new study revealing concerning rates of widespread, physician-directed prescribing of clarithromycin-based regimens for H. pylori infection despite rising rates of antibiotic resistance and prior patient macrolide use.
The data were published in the journal Digestive Diseases and Sciences.
The publication notes that over 80% of all prescriptions for H. pylori infection are clarithromycin-based therapies, despite ACG recommendations to avoid clarithromycin triple therapy in patients with any prior macrolide use or in regions where the resistance rate is known to be 15% or above.
"Such failure rates and resistance have not been seen with Talicia," said Dr. Colin W. Howden, Chief of the Division of Gastroenterology, University of Tennessee Health Science Center.
Since it does not contain clarithromycin, Talicia can be prescribed first-line without having to be concerned about local clarithromycin resistance, prior macrolide use, or patient CYP2C19 status," Dr. Colin added.
Talicia is a fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole).
In November 2019, Talicia was approved by the FDA to treat H. pylori infection in adults.
Life Sciences Virtual Investor Conference: Company Executives Present Live December 16th
Thu, December 9, 2021, 7:19 PM
RDHL
https://finance.yahoo.com/news/life-sciences-virtual-investor-conference-171900475.html
Company executives will share corporate vision and answer audience questions at VirtualInvestorConferences.com
NEW YORK, Dec. 9, 2021 /PRNewswire/ -- Virtual Investor Conferences, the leading proprietary investor conference series, announced the agenda for its quarterly event for public and private companies, investors, and industry professionals from around the world. This day-long virtual event will showcase live company presentations and interactive discussions focused on the life sciences industry.
Individual investors, institutional investors, advisors, and analysts are invited to attend. The program opens at 9:15 AM ET on Thursday, December 16th with the first live webcast at 9:30 AM ET.
REGISTER NOW AT: https://bit.ly/3Go96iH
It is recommended that investors pre-register and run the online system check to expedite participation and receive event updates. There is no cost to log-in, attend the live presentations or ask questions.
"We are delighted to highlight today's innovators from the life science sector," said Jason Paltrowitz, Executive Vice President of Corporate Services at OTC Markets Group. "Our Virtual Investor Conferences continue to provide an efficient platform and unique opportunity for these companies to engage to a broader investor base and communicate their strategies."
Agenda and presenting companies:
Eastern
Time (ET)
Presenting Company
Ticker(s)
9:30 AM
RedHill Biopharma Ltd.
(NASDAQ: RDHL)
10:00 AM
Life Sciences Virtual Investor Conference: Company Executives Present Live December 16th
Thu, December 9, 2021, 7:19 PM
RDHL
https://finance.yahoo.com/news/life-sciences-virtual-investor-conference-171900475.html
Company executives will share corporate vision and answer audience questions at VirtualInvestorConferences.com
NEW YORK, Dec. 9, 2021 /PRNewswire/ -- Virtual Investor Conferences, the leading proprietary investor conference series, announced the agenda for its quarterly event for public and private companies, investors, and industry professionals from around the world. This day-long virtual event will showcase live company presentations and interactive discussions focused on the life sciences industry.
Individual investors, institutional investors, advisors, and analysts are invited to attend. The program opens at 9:15 AM ET on Thursday, December 16th with the first live webcast at 9:30 AM ET.
REGISTER NOW AT: https://bit.ly/3Go96iH
It is recommended that investors pre-register and run the online system check to expedite participation and receive event updates. There is no cost to log-in, attend the live presentations or ask questions.
"We are delighted to highlight today's innovators from the life science sector," said Jason Paltrowitz, Executive Vice President of Corporate Services at OTC Markets Group. "Our Virtual Investor Conferences continue to provide an efficient platform and unique opportunity for these companies to engage to a broader investor base and communicate their strategies."
Agenda and presenting companies:
Eastern
Time (ET)
Presenting Company
Ticker(s)
9:30 AM
RedHill Biopharma Ltd.
(NASDAQ: RDHL)
10:00 AM
RedHill Biopharma: Concerning Rates of Clarithromycin Prescribing for H. pylori, Despite Increasing Antibiotic Resistance, Uncovered in New Digestive Diseases & Sciences Publication
https://finance.yahoo.com/news/redhill-biopharma-concerning-rates-clarithromycin-120000119.html
Despite increasing resistance to, and suboptimal H. pylori eradication rates with, clarithromycin, a new study, published in Digestive Diseases and Sciences, indicates that over 80% of all prescriptions for H. pylori infection contain clarithromycin
In addition, this analysis highlighted a nearly 40% failure rate for clarithromycin-based triple therapies in treatment-naïve patients; Study also showed a more than 80% failure rate in CYP2C19 rapid metabolizers, accounting for approximately 30% of Americans
Talicia, an FDA-approved therapy, is intended for first-line H. pylori eradication therapy
RALEIGH, N.C. and TEL-AVIV, Israel, Dec. 9, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the publication in the journal Digestive Diseases and Sciences of a new study entitled "Pitfalls of Physician-Directed Treatment of Helicobacter pylori: Results from Two Phase 3 Clinical Trials and Real-World Prescribing Data", revealing concerning rates of widespread, physician-directed prescribing of clarithromycin-based regimens for patients with persistent H. pylori infection despite rising rates of antibiotic resistance and prior patient macrolide use.
"The failure rate of clarithromycin-based therapy is alarming enough on its own. More alarming still is that more than 80% of all prescriptions for H. pylori infection are clarithromycin-based therapies – despite clear ACG recommendations to avoid clarithromycin triple therapy in patients with any prior macrolide use or in regions where the resistance rate is known to be 15% or above (or where resistance levels are not known)," said Dr. Colin W. Howden, MD, Professor Emeritus, Chief of the Division of Gastroenterology, University of Tennessee Health Science Center. "Such failure rates and resistance have not been seen with Talicia. Since it does not contain clarithromycin, Talicia can be prescribed first-line without having to be concerned about local clarithromycin resistance, prior macrolide use, or patient CYP2C19 status."
This study assessed prescribing patterns and associated cure rates of physician-directed therapy for subjects with persistent H. pylori infection after participation in either of two Phase 3 clinical trials (ERADICATE Hp and ERADICATE Hp2). The study also conducted CYP2C19 genotype analysis of subjects who were prescribed clarithromycin-based triple therapy. The most frequently selected treatments for physician-directed therapy from ERADICATE Hp and Hp2 were clarithromycin-based triple regimens (71.7%). Clarithromycin-based triple therapies across these studies showed eradication rates of approximately 60%, while rapid CYP2C19 metabolizers had eradication rates of less than 20%. This is clinically relevant because roughly one third of Americans have either rapid or ultra-rapid CYP2C19 metabolizer status[1]. Additionally, the study analyzed real world H. pylori retail prescription data, which revealed that the most frequently selected treatments for physician-directed therapy were clarithromycin-based triple regimens, accounting for more than 80% of prescriptions.
"This study highlights the need for a change in prescribing habits for H. pylori given rising resistance and the suboptimal eradication rates seen with clarithromycin-based regimens. This study demonstrated an approximately 60% eradication rate for clarithromycin-based therapies in treatment naïve patients[2], which is consistent with recently published eradication rates[3]," said Dr. June Almenoff, MD, Ph.D., RedHill's Chief Medical Officer. "Conversely, efficacy data from the two Phase 3 studies demonstrated eradication rates of approximately 89% in the ERADICATE Hp mITT population and 90% in the ERADICATE Hp2 adherent population for Talicia in treatment-naïve subjects, identified no primary or acquired resistance to rifabutin and found that cure rates were largely unaffected by CYP2C19 metabolic status."
About Talicia®
Talicia® is the only rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria seen with other antibiotics. The high rates of H. pylori resistance to clarithromycin have led to significant rates of treatment failure with clarithromycin-based therapies and are a strong public health concern, as highlighted by the ACG, FDA and the World Health Organization (WHO) in recent years.
Talicia® is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia® was approved by the U.S. FDA for the treatment of H. pylori infection in adults. In the pivotal Phase 3 study, Talicia® demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). Minimal to zero resistance to rifabutin, a key component of Talicia®, was detected in RedHill's pivotal Phase 3 study. Further, in an analysis of data from this study, it was observed that subjects who were confirmed adherent[4] to their therapy had response rates of 90.3% in the Talicia® arm vs. 64.7% in the active comparator arm[5].
Talicia® is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034 with additional patents and applications pending and granted in various territories worldwide.
About H. pylori
H. pylori is a bacterial infection that affects approximately 35%[6] of the U.S. population, with an estimated two million patients treated annually[7]. Worldwide, more than 50% of the population has
H. pylori infection, which is classified by the WHO as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer[8] and a major risk factor for peptic ulcer disease[9] and gastric mucosa-associated lymphoid tissue (MALT) lymphoma[10]. More than 27,000 Americans are diagnosed with gastric cancer annually[11]. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics – especially clarithromycin – which is still commonly used in standard combination therapies[12].
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[13], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[14], and Aemcolo® for the treatment of travelers' diarrhea in adults[15]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib ( ABC294640), a first-in-class, oral SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), an oral serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102, with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.
About Talicia® (omeprazole magnesium, amoxicillin and rifabutin)
INDICATION AND USAGE
Talicia is a three-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial, indicated for the treatment of Helicobacter pylori infection in adults.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Talicia and other antibacterial drugs, Talicia should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
IMPORTANT SAFETY INFORMATION
Talicia contains omeprazole, a proton pump inhibitor (PPI), amoxicillin, a penicillin-class antibacterial and rifabutin, a rifamycin antibacterial. It is contraindicated in patients with known hypersensitivity to any of these medications, any other components of the formulation, any other beta-lactams or any other rifamycin.
Talicia is contraindicated in patients receiving rilpivirine-containing products.
Talicia is contraindicated in patients receiving delavirdine or voriconazole.
Serious and occasionally fatal hypersensitivity reactions have been reported with omeprazole, amoxicillin and rifabutin.
Severe cutaneous adverse reactions (SCAR) (e.g. Stevens-Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN)) have been reported with rifabutin, amoxicillin, and omeprazole. Additionally, drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with rifabutin.
Acute Tubulointerstitial Nephritis has been observed in patients taking PPIs and penicillins.
Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range from mild diarrhea to fatal colitis.
Talicia may cause fetal harm. Talicia is not recommended for use in pregnancy. Talicia may reduce the efficacy of hormonal contraceptives. An additional non-hormonal method of contraception is recommended when taking Talicia.
Talicia should not be used in patients with hepatic impairment or severe renal impairment.
Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs. These events have occurred as both new onset and exacerbation of existing autoimmune disease.
The most common adverse reactions (≥1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis.
To report SUSPECTED ADVERSE REACTIONS, contact RedHill Biopharma INC. at
1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Full prescribing information for Talicia is available at www.Talicia.com
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®, and Aemcolo® and Movantik®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.
Company contact:
Adi Frish
Chief Corporate & Business Development Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
Media contacts:
U.S.: Bryan Gibbs, Finn Partners
+1 212 529 2236
bryan.gibbs@finnpartners.com
UK: Amber Fennell, Consilium
+44 (0) 7739 658 783
fennell@consilium-comms.com
Category: R&D
[1] Ionova Y, Ashenhurst J, Zhan J et al. CYP2C19 allele frequencies in over 2.2 million direct-to-consumer genetics research participants and the potential implication for prescriptions in a large health system. Clin Transl Sci. 2020;13:1298–1306 https://doi.org/10.1111/cts.12830
[2] mITT population who failed placebo as primary treatment, who entered into physician directed care phase
[3] Argueta, E. A., Alsamman, M. A., Moss, S. F., & D'Agata, E. M. C. (2021). Impact of Antimicrobial Resistance Rates on Eradication of Helicobacter pylori in a US Population. Gastroenterology, 160(6), 2181-2183 e2181. https://doi.org/10.1053/j.gastro.2021.02.014
Malfertheiner, P., Megraud, F., O'Morain, C. A., Atherton, J., Axon, A. T., Bazzoli, F., Gensini, G. F., Gisbert, J. P., Graham, D. Y., Rokkas, T., El-Omar, E. M., Kuipers, E. J., & European Helicobacter Study, G. (2012). Management of Helicobacter pylori infection--the Maastricht IV/ Florence Consensus Report. Gut, 61(5), 646-664. https://doi.org/10.1136/gutjnl-2012-302084
O'Connor, A., Gisbert, J. P., O'Morain, C., & Ladas, S. (2015). Treatment of Helicobacter pylori Infection 2015. Helicobacter, 20 Suppl 1, 54-61. https://doi.org/10.1111/hel.12258
Venerito, M., Krieger, T., Ecker, T., Leandro, G., & Malfertheiner, P. (2013). Meta-analysis of bismuth quadruple therapy versus clarithromycin triple therapy for empiric primary treatment of Helicobacter pylori infection. Digestion, 88(1), 33-45. https://doi.org/10.1159/000350719
[4] Defined as the PK population which included those subjects in the ITT population who had demonstrated presence of any component of investigational drug at visit 3 (approx. day 13) or had undetected levels drawn >250 hours after the last dose.
[5] The pivotal Phase 3 study with Talicia® demonstrated 84% eradication of H. pylori infection with Talicia® vs. 58% in the active comparator arm (ITT analysis, p<0.0001).
[6] Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429.
[7] IQVIA Custom Study for RedHill Biopharma, 2019
[8] Lamb A et al. Role of the Helicobacter pylori–Induced inflammatory response in the development of gastric cancer. J Cell Biochem 2013;114.3:491-497.
[9] NIH – Helicobacter pylori and Cancer, September 2013.
[10] Hu Q et al. Gastric mucosa-associated lymphoid tissue lymphoma and Helicobacter pylori infection: a review of current diagnosis and management. Biomarker research 2016;4.1:15.
[11] National Cancer Institute, Surveillance, Epidemiology, and End Results Program (SEER).
[12] Malfertheiner P. et al. Management of Helicobacter pylori infection - the Maastricht IV/ Florence Consensus Report, Gut 2012;61:646-664; O'Connor A. et al. Treatment of Helicobacter pylori Infection 2015, Helicobacter 20 (S1) 54-61; Venerito M. et al. Meta-analysis of bismuth quadruple therapy versus clarithromycin triple therapy for empiric primary treatment of Helicobacter pylori infection. Digestion 2013;88(1):33-45.
[13] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.
[14] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.
[15] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.
Cision
Cision
View original content:https://www.prnewswire.com/news-releases/redhill-biopharma-concerning-rates-of-clarithromycin-prescribing-for-h-pylori-despite-increasing-antibiotic-resistance-uncovered-in-new-digestive-diseases--sciences-publication-301441040.html
SOURCE RedHill Biopharma Ltd.
shouldn’t we sell more shares at 6 and raise twice as much or at 12 and raise 4 times as much
In hindsight, sure. The decision when is always a
tough one. On one hand RDHL has some cash, on the
other the company has a hefty cash burn amount due
to various trials and activities.
In short your question is good, but more like in the
category of: Could have, should have, would have .
Thanks midas but if we have cash to last a while, shouldn’t we sell more shares at 6 and raise twice as much or at 12 and raise 4 times as much or sell less shares and dilute less? Makes no sense to me but I’m holding anyway - only 4,000 shares
1) why aren’t we much higher?
Disappointment from company lack of performance
coupled with general bio underperformance:
Big-name biotech hedge funds have_been_hammered_ this_ year:
https://www.wsj.com/articles/hedge-funds-suffer-big-losses-on-biotech-rout-11638727155
Quote:
Perceptive Advisors, a prominent biotech hedge fund that manages about $9 billion, lost about 30% this year through November in its main fund, investors say. A hedge fund managed by OrbiMed Partners, which invests more than $18 billion in healthcare in public and private markets, has lost more than 40% this year through November…
…The SPDR S&P Biotech ETF (XBI), an equal-weighted index of biotech stocks, has fallen about 22% so far this year through Friday, and is down 37% from its Feb. 8 peak.
Unquote
2) why did we issue more shares to raise money and cause unecessary dilution?
Companies raise whenever they can, not necessarily when they need.
Am i happy? No, but i still hold my shares!
Listening to the conference call now
As of 9/30/21, we had over $51 million and had $21 million in revenues.
2 questions
1) why aren’t we much higher?
2) why did we issue more shares to raise money and cause unnecessary dilution?
RedHill Biopharma says its experimental oral COVID-19 drugs not affected by Omicron
Dec. 06, 2021 9:00 AM ETRedHill Biopharma Ltd. (RDHL)
By: Dulan Lokuwithana, SA News Editor2 Comments
RedHill Biopharma (NASDAQ:RDHL) announced that the newly detected Omicron variant of the coronavirus is unlikely to impact its experimental COVID-19 therapies, Opaganib and RHB-107.
Opaganib developed for hospitalized patients with the advanced form of the disease, targets the human host cell rather than the virus, and, therefore, it is “not expected to be impacted by spike protein mutations,” the company said.
While COVID-19 pills developed by Pfizer (NYSE:PFE) and Merck (NYSE:MRK) require a 3-5-day period to begin their treatments following the onset of symptoms, Opaganib is started at a median of 11 days following the beginning of symptoms.
In a regulatory update, RedHill (RDHL) said that Phase 2/3 data for Opaganib have been submitted to the European Medicines Agency (EMA) and the FDA with initial feedback from two regulatory agencies expected by the end of the year and January 2022, respectively.
The data submissions have already been made to the UK (MHRA), and the regulatory submissions to several other countries, including South Africa, Russia, and Israel, are also lined up.
Topline data from Part A of its Phase 2/3 study for RHB-107 in non-hospitalized patients is expected in Q1 2022.
Read more on upcoming milestones for RedHill (RDHL) as announced by its management last month.
RedHill Biopharma Reports that Opaganib Mechanism Not Impacted by Viral Spike-Protein Mutations, Including Omicron Mutations
https://finance.yahoo.com/news/redhill-biopharma-reports-opaganib-mechanism-120000685.html
Unique Mode of Action
Opaganib works by targeting the human host cell rather than the virus itself and is therefore not expected to be impacted by spike protein mutations, providing a strong rationale for its potential to address the Omicron SARS-CoV-2 variant, as well as other variants of concern
Regulatory update
Opaganib global Phase 2/3 data packages submitted to European EMA, with initial feedback expected by end of year, to the U.S. FDA with initial feedback expected in January, and to the UK MHRA, with other countries lined up
A number of pending grant applications in the U.S. and abroad with both government bodies and non-government entities
Opaganib designed for underserved hospitalized patient population with advanced disease; Opaganib treatment initiated a median of 11 days from symptom onset in the Phase 2/3 global study, compared to the limited 3-5-day from symptom onset scope of the Pfizer & Merck pills
RHB-107, RedHill's other oral COVID-19 drug candidate, expected to deliver top-line data in Q1/2022 from Part A of its Phase 2/3 study in non-hospitalized patients in the U.S. and South Africa; RHB-107 also not expected to be impacted by spike protein mutations
TEL AVIV, Israel and RALEIGH, N.C., Dec. 6, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that because opaganib's[1] proposed mechanism of action is not impacted by spike protein mutations, opaganib is expected to be unaffected by mutations associated with Omicron and other known variants of concern. The Company also provided an update on the status of its regulatory submissions for opaganib.
Increased hospitalizations in South Africa due to Omicron highlight the urgent need for drugs aimed at moderately severe COVID-19 patients with pneumonia requiring hospital treatment. By focusing on this large group of patients, opaganib, if approved, would target an entirely different and sicker patient population than the Pfizer and Merck oral drug candidates, which showed benefit only in non-hospitalized patients at the earliest stages of symptomatic infection.
Opaganib acts independently of mutations to the viral spike protein. We believe that its unique proposed mechanism of action - targeting a protein in the human cell required by the virus for replication rather than the virus itself - holds significant potential versus Omicron and other existing and emerging variants with mutations to the spike protein. Extensive clinical and non-clinical data support the rationale for accelerating this program, including clinical data from Phase 2 and Phase 2/3 studies, compassionate use experience and strong inhibition against variants of concern, including Delta.
"Omicron is just another reminder that COVID-19 is an endemic virus at this point, and it is not going away. The evolution of this virus will continue as long as it circulates, and we will need to continue to tweak our vaccines and monoclonal antibodies in order to respond to new variants as they arise. Most importantly, this underscores the need for safe and effective anti-viral therapies that will continue to work no matter which variants present themselves. It is vital that focus, time and resources are given to the development of anti-viral therapies that can effectively treat those COVID-19 high risk patients, preferably without concern for variants and mutations," said Kevin Winthrop, MD, MPH, Professor of Infectious Diseases at Oregon Health & Science University. "The post-hoc data from the opaganib Phase 2/3 study in moderate and severe COVID-19 patients is intriguing and suggests the possibility that opaganib might prove itself as an effective anti-viral in this setting. In a subpopulation of patients defined as moderately severe based on their level of baseline oxygen supplementation, mortality was 62% lower in those using opaganib (16% placebo Vs. 6% opaganib). The results suggest a sub-group of patients who would likely benefit from this therapy, and they highlight the need for additional studies in the development of this therapy."
Regulatory & Development Update:
Given the promising clinical results to-date in the moderately severe hospitalized patient population in a large subpopulation analysis of the global Phase 2/3 study, RedHill is vigorously pursuing the development program for opaganib:
Submitted data packages to the U.S. FDA, the European Medicines Agency (EMA) and the UK (MHRA) actively seeking scientific advice on the potential path towards approval of opaganib. The EMA has indicated a rapid procedure timeline, and we expect their advice by end of the year, with preliminary feedback from the FDA expected in January 2022.
Pursuing submission in other countries including South Africa, Russia, Israel, Switzerland, India, Brazil and Colombia.
Discussions and preparation ongoing for a confirmatory study with opaganib in the targeted moderately severe hospitalized patient group, engaging with the FDA, other regulatory bodies as well as other government agencies on the need to further accelerate development of much needed therapeutics, such as opaganib and RHB-107, against Omicron and emerging variants.
A number of pending grant applications in the U.S. and abroad with both government bodies and non-government entities.
"Both opaganib and RHB-107 have unique human cell-targeted mechanisms of action that act independently of mutations at the spike protein. Given the gravity of the threat presented by Omicron, and the likely emergence of other variants, RedHill is pursuing development of these two promising COVID-19 pills as quickly and diligently as possible. We have extensive safety data and, in the case of opaganib, an apparent clinical benefit in reducing mortality, getting patients back onto room air and getting them out of hospital faster," said Gilead Raday, RedHill's Head of R&D "Importantly, opaganib benefited a population of hospitalized patients in moderately severe condition with treatment being initiated a median of 11 days from the onset of symptoms in our Phase 2/3 global study. This distinguishes opaganib as a potential game-changer for advanced COVID-19 patients who are at a significant risk of dying from their condition and already well beyond the 3-5-day from symptom onset scope offered by the Pfizer and Merck anti-viral pills."
Unique Opaganib Proposed Mechanism of Action:
Opaganib is a sphingosine kinase-2 (SK2) inhibitor, a promising and differentiated approach that targets the SK2 human host cell factor rather than the virus itself, working independently of spike protein mutations, such as those associated with Omicron and emerging variants of concern. SARS-CoV-2, the virus which causes COVID-19 disease, is a positive-sense single-stranded RNA (+ssRNA) virus, which account for more than one-third of all known virus genera. These viruses use host factors in various steps of viral infection, such as cell entry and replication - SK2 is one such factor, potentially making it a broad-spectrum antiviral target. SK2 is also active in the modulation of certain pro-inflammatory cytokines, with in vivo studies demonstrating opaganib's potential to ameliorate inflammatory lung disorders and decrease renal fibrosis by reduction of IL-6 and TNF-alpha levels in bronchoalveolar lavage fluids. Thus, inhibition of SK2 may deliver a 2-pronged antiviral and anti-inflammatory effect – a highly desirable mechanism in the case of COVID-19. Moreover, opaganib's targeting of SK2 and not the virus itself, means it is expected to uphold antiviral activity irrespective of the worrisome mutations in the SARS-CoV-2 spike protein and the emergence of new strains, such as Omicron, which may be evasive of direct antiviral antibodies and vaccines.
RHB-107 Mode of Action and Development Status
RHB-107[2], RedHill's other oral COVID-19 drug candidate, is a once-daily oral capsule, given early in the course of the disease, to outpatients. It targets Serine Proteases, which are human enzymes that are involved in facilitating the entry of SARS-CoV-2 into target cells. The cleaving of the spike protein by these host human serine proteases, is a necessary step in viral attachment and entry into the cells, which is independent of the mutations observed in the Omicron variant that are altering the spike-protein antigenic properties.
RHB-107 is currently being evaluated in a Phase 2/3 study in non-hospitalized COVID-19 patients in the U.S. and in South Africa. Recruitment for part A of the study has been completed and top-line results are expected in the first quarter of 2022.
About Opaganib (ABC294640)
Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, with proposed dual anti-inflammatory and antiviral activity. Opaganib is host-targeted and is expected to be effective against emerging viral variants, having already demonstrated strong inhibition against variants of concern, including Delta. Opaganib has also shown anticancer activity and positive preclinical results in renal fibrosis, and also has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.
Opaganib previously delivered positive U.S. Phase 2 data in patients with moderate to severe COVID-19, submitted for peer review and recently published in medRxiv.
Opaganib has also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Patient accrual, treatment and analysis in this study are ongoing.
Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, inhibiting viral replication of all SARS-CoV-2 variants tested to date in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies have demonstrated opaganib's potential to ameliorate inflammatory lung disorders, such as pneumonia, have demonstrated opaganib's potential to decrease renal fibrosis and have shown decreased fatality rates from influenza virus infection and amelioration of Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids[3].
The ongoing clinical studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.
The top-line results from the Company's Phase 2/3 study with opaganib are preliminary in nature. The Company intends to further examine the data from this study in greater detail, along with all the information gathered during this study, including all safety, and secondary outcome measures. Such analysis may result in findings which are new or inconsistent with the top-line data disclosed in this release. As such, investors should not rely on the analyses reported in this release as the final definitive results of the study.
About RHB-107 (upamostat)
RHB-107 is a proprietary, first-in-class, orally-administered antiviral, that targets human serine proteases involved in preparing the spike protein for viral entry into target cells. RHB-107 targets human cell factors involved in preparing the spike protein for viral entry into target cells and is therefore expected to be effective against emerging viral variants with mutations in the spike protein. RHB-107 is being evaluated in a Phase 2/3 study, in the U.S. and South Africa, for treatment of patients with symptomatic COVID-19 who do not require inpatient care. In addition, RHB-107 inhibits several proteases targeting cancer and inflammatory gastrointestinal disease. RHB-107 has undergone several Phase 1 studies and two Phase 2 studies, demonstrating its clinical safety profile in approximately 200 patients. RedHill acquired the exclusive worldwide rights to RHB-107, excluding China, Hong Kong, Taiwan and Macao, from Germany's Heidelberg Pharmaceuticals (FSE: HPHA) (formerly WILEX AG) for all indications.
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[4], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[5], and Aemcolo® for the treatment of travelers' diarrhea in adults[6]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (ABC294640), a first-in-class oral SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), an oral serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 , with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com/ twitter.com/RedHillBio.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk of a regulatory feedback regarding the Phase 2/3 data packages submitted to the regulatory authorities, the risk of a delay in top-line data from Part A of the Phase 2/3 study of once-daily oral RHB-107 in non-hospitalized patients with symptomatic COVID-19, the risk that further analysis of the top-line results of the Phase 2/3 COVID-19 study for opaganib results in findings inconsistent with the data disclosed in this release; that no further COVID-19 studies for opaganib will be commenced, and if commenced, may not be successful, including with respect to moderately severe COVID-19 and patients in earlier stages of COVID-19 on low flow oxygen support; that any additional studies for opaganib in COVID-19 patients, even if successful, will not be sufficient for regulatory applications, including emergency use or marketing applications, that the Phase 2/3 COVID-19 study for RHB-107 may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib and RHB-107 will be required by regulatory authorities to support such potential applications and the use or marketing of opaganib or RHB-107 for COVID-19 patients, that opaganib and RHB-107 will not be effective against emerging viral variants, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.
Company contact:
Adi Frish
Chief Corporate & Business Development Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
Media contacts:
U.S.: Bryan Gibbs, Finn Partners
+1 212 529 2236
bryan.gibbs@finnpartners.com
UK: Amber Fennell, Consilium
+44 (0) 7739 658 783
fennell@consilium-comms.com
Category: R&D
[1] Opaganib is an investigational new drug, not available for commercial distribution.
[2] RHB-107 is an investigational new drug, not available for commercial distribution.
[3] Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.
[4] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.
[5] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.
[6] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.
SOURCE RedHill Biopharma Ltd.
RedHill Bio gains 6% after Talicia shows efficacy in eradicating H. pylori infection
Dec. 02, 2021 7:41 AM ETRedHill Biopharma Ltd. (RDHL)
By: Mamta Mayani, SA News Editor
RedHill Biopharma (NASDAQ:RDHL) announces the publication of a new study in the journal GastroHep, showing the high efficacy of Talicia in eradicating H. pylori irrespective of patient BMI and level of obesity in clinical trials.
RDHL shares up 6.3% premarket at $2.89.
This new publication, describing a post-hoc analysis of data from 269 patients from the ERADICATE Hp and ERADICATE Hp2 Phase 3 clinical trials showed that Talicia maintained high efficacy across all BMI groups compared to the active comparator including in obese and severely obese patients (P<0.0001).
Patients with a BMI between 30-40 kg/m2 and those with BMI >40kg/m treated with Talicia achieved eradication rates of ~90% (88.1% and 90.9% respectively) versus active comparator rates of 62.9% and 31.8% respectively – the active comparator demonstrated nearly 50% lower efficacy in the severely obese group.
No cases of rifabutin resistance were identified in this study.
Generally, no differences were identified in the safety of Talicia across BMI groups, consistent with its overall safety profile.
H. pylori is a bacterial infection that affects ~35% of the U.S. population
RedHill Biopharma Data Published in GastroHep Shows Consistent Efficacy of Talicia Irrespective of Patient BMI
https://finance.yahoo.com/news/redhill-biopharma-data-published-gastrohep-120000559.html
High Body Mass Index and obesity are known risk factors for H. Pylori eradication treatment failure; Newly published data in GastroHep shows high eradication rates for Talicia® across BMI groups
Data from a post-hoc analysis showed H. pylori eradication rates with Talicia of 88.1% and 90.9% in patients with BMI> 30/<40kg/m2 and in patients with BMI>40 kg/m2, respectively, versus active comparator rates of 62.9% and 31.8% respectively - an almost 50% difference in efficacy from the active comparator in the severely obese group
Talicia, an FDA approved therapy, may be used as first-line H. pylori eradication therapy
TEL-AVIV, Israel and RALEIGH, N.C., Dec. 2, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announces the publication of a new study entitled "Helicobacter pylori Eradication by Low-Dose Rifabutin Triple Therapy (Talicia®) is Unaffected by High Body Mass Index" in the journal GastroHep, showing the high efficacy of Talicia in eradicating H. pylori irrespective of patient BMI and level of obesity in clinical trials.
This new publication, describing a post-hoc analysis of data from 269 patients from the ERADICATE Hp and ERADICATE Hp2 Phase 3 clinical trials who had BMI >30 kg/m2, showed that Talicia maintained high efficacy across all BMI groups compared to the active comparator including in obese and severely obese patients (P<0.0001). Patients with a BMI between 30-40 kg/m2 and those with BMI >40kg/m treated with Talicia achieved eradication rates of approximately 90% (88.1% and 90.9% respectively) versus active comparator rates of 62.9% and 31.8% respectively – the active comparator demonstrated nearly 50% lower efficacy in the severely obese group.
"High BMI and obesity are known risk factors for H. Pylori eradication treatment failure[1]. Data from previous studies[2] have shown that the failure rate of clarithromycin triple therapy can increase by nearly 300% in patients with high BMI, from nearly 15% in patients with BMIs<25 kg/m2 to 45% in subjects with BMIs≥25 kg/m2," said Prof. John Yung-Chong Kao, MD, Professor of Internal Medicine, Division of Gastroenterology, University of Michigan, and lead author of the paper. "With more than 70% of American adults being overweight or obese, it is important to understand the influence of patient BMI on H. pylori eradication treatment success. These data support that low-dose rifabutin-containing therapy such as Talicia can be considered as a first line therapy to treat H. pylori infection particularly in patients with high BMI."
No cases of rifabutin resistance were identified in this study, compared to a pooled clarithromycin resistance rate of more than 17% seen across all BMI groups, which highlights the potential risk of empirically prescribing clarithromycin-containing regimens for the treatment of H. pylori. Generally, no differences were identified in the safety of Talicia across BMI groups, consistent with its overall safety profile.
"The obese population experiences more infections and thus has more antibiotic exposure than the general population, potentially leading to higher rates of antibiotic-resistant organisms," said Dr. June Almenoff, MD, Ph.D., RedHill's Chief Medical Officer." Given the medical risks associated with obesity, it is especially important to use highly effective treatments such as Talicia, to provide patients with a high probability of cure with first-line treatment."
RedHill Biopharma's Movantik® Added as Preferred and Unrestricted Brand To Major National Medicare Formulary Serving Millions of Americans
https://finance.yahoo.com/news/redhill-biopharmas-movantik-added-preferred-122200874.html
Movantik® approved for inclusion as preferred and unrestricted brand on a major National Medicare Part D formulary serving more than 10 million Americans as of January 1, 2022
Movantik's total commercial coverage extends to 152 million American patients' lives and will grow to 46 million Medicare lives and will increase to over 94% coverage of Medicare Part D lives
Movantik is the U.S. market-leading oral peripherally acting mu-opioid receptor antagonist (PAMORA), approved to treat opioid-induced constipation in adults with chronic non-cancer pain
TEL AVIV, Israel and RALEIGH, N.C., Dec. 1, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that one of America's largest payors, serving more than 10 million Americans through multiple Medicare plans, has approved the inclusion of Movantik® (naloxegol), a peripherally acting mu-opioid receptor antagonist (PAMORA) for opioid-induced constipation, as a preferred and unrestricted brand on its National Medicare Part D formulary starting January 1, 2022.
"It is important for optimal chronic pain treatment that patients are able to manage the debilitating constipation that often accompanies opioid therapy and have access to treatments such as Movantik," said Rick Scruggs, RedHill's Chief Commercial Officer. "This important new listing for Movantik, the market-leading PAMORA for opioid-induced constipation, as a preferred and unrestricted brand on a major National Medicare Part D formulary provides that access to more than 10 million more Americans covered by this formulary. Movantik now has coverage of 90% of U.S. commercial lives and will increase to over 94% coverage of Medicare Part D lives, as we continue our efforts to increase patient access to Movantik."
About Movantik® (naloxegol)
Movantik® is an opioid antagonist indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.
Important Safety Information About Movantik
Movantik® (naloxegol) is contraindicated in:
Patients with known or suspected gastrointestinal (GI) obstruction and patients at risk of recurrent obstruction, due to the potential for GI perforation.
Patients receiving strong CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole) because these medications can significantly increase exposure to naloxegol which may precipitate opioid withdrawal symptoms.
Patients with a known serious or severe hypersensitivity reaction to Movantik or any of its excipients.
Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, irritability, and yawning, occurred in patients treated with Movantik. Patients receiving methadone as therapy for their pain condition were observed in the clinical trials to have a higher frequency of GI adverse reactions that may have been related to opioid withdrawal than patients receiving other opioids. Patients with disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal or reduced analgesia. These patients (e.g., multiple sclerosis, recent brain injury, Alzheimer's disease, and uncontrolled epilepsy) were not enrolled in the clinical studies. Take into account the overall risk-benefit profile when using Movantik in such patients. Monitor for symptoms of opioid withdrawal when using Movantik in such patients.
Severe abdominal pain and/or diarrhea have been reported, generally within a few days of initiation of Movantik. Monitor and discontinue if severe symptoms occur. Consider restarting Movantik at 12.5 mg once daily.
Cases of GI perforation have been reported with the use of peripherally acting opioid antagonists, including Movantik. Postmarketing cases of GI perforation, including fatal cases, were reported when Movantik was used in patients at risk of GI perforation (e.g., infiltrative gastrointestinal tract malignancy, recent gastrointestinal tract surgery, diverticular disease including diverticulitis, ischemic colitis, or concomitantly treated with bevacizumab). Monitor for severe, persistent, or worsening abdominal pain; discontinue if this symptom develops.
The most common adverse reactions with Movantik as compared to placebo in clinical trials were: Abdominal pain (21% vs 7%), diarrhea (9% vs 5%), nausea (8% vs 5%), flatulence (6% vs 3%), vomiting (5% vs 4%), headache (4% vs 3%), and hyperhidrosis (3% vs <1%).
Movantik (naloxegol) is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.
Click here for the Medication Guide and full Prescribing Information for Movantik.
You are encouraged to report Adverse Reactions to RedHill Biopharma Inc. at 1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
MOVANTIK is a registered trademark of the AstraZeneca group of companies.
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NCI
BARDA
U.S. Department of Defense
FDA Office of Orphan Products Development
Top-line data from the 270-patient global Phase 2/3 COVID-19 study expected Q1/2021
Top-line data from the 40-patient U.S. Phase 2 study of opaganib in severe COVID-19 expected in the coming days; this non-powered study was designed to evaluate safety and potential identification of preliminary efficacy signals in support of the global Phase 2/3 study of opaganib
(Posted 12/22/2020)
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[1] https://www.redhillbio.com/RedHill/Templates/showpage.asp?DBID=1&LNGID=1&TMID=178&FID=1358&PID=0&IID=1899
[2] https://www.redhillbio.com/RedHill/Templates/showpage.asp?DBID=1&LNGID=1&TMID=178&FID=2432&PID=0&IID=17299
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02-07-2021
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