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I hope you are right. I would be delighted if the Brilacidin for Covid 19 results are so positive it would get an immediate pass to an EUA.
Pfizer on the other hand may be hesitant to submit another drug for an early EUA after Merck's experience.
Merck partnered with Oncoimmune for their graft vs host drug for Covid 19 and surprisingly got rejected. Then,in spite of a good Covid 19 anti-inflammatory study; they pulled the drug.
Then you couple that with Cytodyn's experience it appears the FDA is becoming less welcoming.
GLTA,
Farrell
https://www.fiercebiotech.com/biotech/fda-tells-merck-told-to-show-more-data-for-its-oncoimmune-covid-drug-as-eua-pushed-back
https://www.merck.com/news/merck-to-discontinue-development-of-mk-7110-for-covid-19/
https://www.biospace.com/article/releases/oncoimmune-s-saccovid-cd24fc-exhibits-superb-therapeutic-efficacy-a-potential-breakthrough-in-treating-severe-and-critical-covid-19/
Kevetrin is a P53 drug. Unless the tumor genetic profile testing also showed a P53 mutation it is unlikely to be effective.
Many cancers have multiple genetic mutations. P53 mutations are not uncommon in non small cell lung cancer.
https://cancerci.biomedcentral.com/articles/10.1186/s12935-019-0910-2
Hopefully IPIX will have the resources to study Kevetrin completely some day.
GLTA Farrell
It will be interesting to see if Sotrvimab is the first monoclonal antibody approved for mild to moderate Covid19. Most of the other monoclonals are now seeking approval for prophylaxisis in high risk patients since they were unable to show efficacy in the mild,moderate or severely ill Covid 19 patients.
Sotrovimab had some very positive attributes. It was effective at a low dose,it appears to be reasonably safe with good pharmocokinetics.
You can look at statistics in different ways. The authors summary showed statistical validity:
... interim study results demonstrated an 85% (p=0.002) reduction in hospitalization for more than 24 hours or death in those receiving sotrovimab compared to placebo.
Another way to look at the results was they treated 583 high risk patients to prevent 1 death and 18 hospitalizations {21-3}.
While that would probably warrant approval in the US, Japan or EU. I am not sure that other countries would find that calculation enough of a value to extend treatment to the high risk individuals.
The other monoclonal antiboies for Covid failed to show good results when large numbers of patients were treated.
We will have to wait until Sotrovimab completes its studies.
GLTA Farrell
The employees of the CDC should be the best informed group in the world to decide the value of Covid vaccination.
Why isn't their vaccination rate a 100%?
During the hearings one of the panel discussed the efforts of the CDC to increase the vaccination rates. Do they believe they can further educate this group? Why is that necessary?
Some of the answers are there are real concerns about the value of the vaccine especially to the young and healthy.There are concerns the vaccine was rushed through testing.Concerns regarding the long term side effects. Concerns that previous MRNA vaccines not only failed animal testing ,but result in the deaths of most of the animals.
That being said I took the vaccine because I felt my exposure to the the public and other factors put me and my family at a higher risk of infection.
Everyone's situation is different and many very well informed and educated individuals have made the decision to not take the vaccine.
GLTA,
Farrell
Sotrovimab is a monoclonal antibody which attaches to the Spike protein of the Coronavirus.
This is the same site of attachment as the other Covid 19 monoclonal antibodies, baricitinib, bamlanivimab,as well as Regeneron's antibiotic cocktail of casirivimab and imdevimab; all have been given an EUAs but have not approved as Covid 19 therapeutics.
The other monoclonal antibodies for Covid all block viral entry into the human cells to prevent infection. Sotrovimab also blocks viral cell entry, but its mechanism is defined in a more detailed manner:
"Sotrovimab inhibits an undefined step that occurs after virus attachment and prior to fusion of the viral and cell membranes."
"Sotrovimab is a recombinant human IgG1-kappa mAb that binds to a conserved epitope on the spike protein receptor binding domain of SARS-CoV-2 with a dissociation constant KD = 0.21 nM) but does not compete with human ACE2 receptor binding (IC50 value >33.6 nM [5 µg/mL]). Sotrovimab inhibits an undefined step that occurs after virus attachment and prior to fusion of the viral and cell membranes. The Fc domain of sotrovimab includes M428L and N434S amino acid substitutions (LS modification) that extend antibody half-life, but do not impact wild-type Fc-mediated effector functions in cell culture."
The FDA seems concerned Sotrovimab will share so of the other Covid 19 monoclonal antibody side effects and listed them in the physicians insert as a warning to doctors treating Covid19 patients.
"5.2 Clinical Worsening After SARS-CoV-2 Monoclonal Antibody AdministrationClinical worsening of COVID-19 after administration of SARS-CoV-2 monoclonal antibody treatment has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrythmia (e.g., atrial fibrillation, tachycardia, bradycardia), fatigue, and altered mental status. Some of these events required hospitalization. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of
Covid19"
GLTA, Farrell
Sotrovimab FDA letter to providers:
1. Benefit of treatment with sotrovimab has not been observed in patients hospitalized due to COVID-19. SARS-CoV-2 monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.
2.Sotrovimab is not authorized for use in patients: owho are hospitalized due to COVID-19, OR owho require oxygen therapy due to COVID-19, OR owho require an increase in baseline oxygen flow rate due to COVID-19 (in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity).
3. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive care. Infusion-related reactions, occurring during theinfusion andup to 24 hours after the infusion, have been observed with administration of sotrovimab. These reactions may be severe or life threatening. Signs and symptoms of infusion-related reactions may include: ?fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g., atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vaso-vagal reactions (e.g., pre-syncope, syncope), dizziness, and diaphoresis.Consider slowing or stopping the infusion and administer appropriate medications and/or supportive care if an infusion-related reaction occurs. Hypersensitivity reactions occurring more than 24 hours after the infusion have also been reported with the use of SARS-CoV-2 monoclonal antibodies under Emergency Use Authorization.
4.Clinical Worsening After SARS-CoV-2 Monoclonal Antibody Administration Clinical worsening of COVID-19 after administration of SARS-CoV-2 monoclonal antibody treatment has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrythmia (e.g., atrial fibrillation, tachycardia, bradycardia), fatigue, and altered mental status. Some of these events required hospitalization. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19.
https://www.fda.gov/media/149534/download
GLTA Farrell
I believe you are on the right path. The normal course would be to wait until all the data is completely reviewed,but these are not normal times, here or abroad.
According to the CDC 438 individuals died from Covid last week in the US. 50% of the population is vaccinated,but the vaccination rates are dropping sharply. Tens of thousands are dying abroad.
https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.html
I think the Remdeivir model and timeline still applies since another Covid antiviral has not been approved and additional experience with Remdesivir has not confirmed the early enthusiasm.
Remdesivir was given on a compassionate use basis at the very beginning of the US infections in January 2020. This is before any of the clinical trials were finished, but based on studies done for Ebola, SARS and MERs.
https://www.nejm.org/doi/full/10.1056/NEJMoa2007016
In March of 2020 Gilead began an expanded compassionate use program. The first Redesivir Covid 19 trial was begun in China , but suspended. The adaptive phase 2-3 trial was begun on 2/21/2020 and first results posted on 9/25/2020
EUA was granted on May 1,2020 and approval by the FDA was given on 10/25/2020.
IMO that gives a timeline on how Brilacidin may progress.
If the phase 2 Brilacidin trial is very positive. I believe expanded compassionate use could be begin soon. To be quickly followed by an announcement of a phase 3 study with grants and possible partnership. If the phase 3 study shows promise at the first interim report we could see an EUA. Formal FDA approval would be given after the phase 3 trial is completed.
If the phase 2 trial shows modest results, ie better than Remdesivir, we could still see the course accelerated.
Time will tell.
Good luck to all,
Farrell
In addition to being unemployed and open to endless law suits the CEO could receive up to 5 years for lying to Congress.
Too bad they can not get to their overseers eg Citadel and others.
GLTA,
Farrell
Another great post
Thanks
GLTA,
Farrell
I think you are close for the 120. They seem to want to complete a few extra just in case they are needed.
GLTA, Farrell
Precision vaccinations provides a good summary of Covid medicines as well as updates.
Thanks for the reminder.
https://www.precisionvaccinations.com/vaccines/brilacidin-covid-19-therapeutic
GLTA,Farrell
One additional PR should have been added:
"data from a leading Public Health Research Institute (PHRI) showing Brilacidin inhibits SARS-CoV-2, the novel coronavirus responsible for COVID-19, in a human cell line. Brilacidin, in comparison to vehicle control, exhibited an inhibitory effect on SARS-CoV-2 in a dose-dependent manner—an average 29 percent inhibition at 0.1ug/ml (the lowest concentration) to an 85 percent inhibition at 100ug/ml (the highest concentration)."
http://www.ipharminc.com/press-release/2020/5/26/innovation-pharmaceuticals-receives-data-from-public-health-research-institute-showing-brilacidin-inhibits-sars-cov-2-covid-19-in-a-human-cell-line
GLTA Farrell
This PR I believe is the first mention of the PHRI and its plans to research Brilacidin.
http://www.ipharminc.com/press-release/2020/5/5/inhibitory-effect-of-innovation-pharmaceuticals-brilacidin-on-sars-cov-2-covid-19-in-primary-human-immune-cells-to-be-studied-at-leading-public-health-research-institute
"This new research is separate from the previously announced antiviral studies being conducted at a U.S. Regional Biocontainment Laboratory (RBL), which over the weekend informed us that the next phase of Brilacidin testing has commenced.
Scientists at the Public Health Research Institute plan to evaluate Brilacidin’s inhibitory effect on SARS-CoV-2 viral replication in primary immune mediators (peripheral blood mononuclear cells, T cells, B cells, monocytes, macrophages) obtained from both young and old donors to assess age-dependent host responses to the novel coronavirus. Brilacidin drug substance has been received by the Institute and is now available for testing."
The PHRI was founded in New York City as a research health center. It later became affiliated with Rutger University.
https://phri.njms.rutgers.edu/
The PHRI has a relationship with the " Bio-Safety Level 3 (BSL3) vivarium and laboratory spaces dedicated to study infectious diseases and highly transmissible pathogenic agents".
https://phri.njms.rutgers.edu/programs-and-resources/bls3-vivarium-facility/
The Rutgers BSL3 lab is one of the national NIH affiliated Biodefense labs.
https://phri.njms.rutgers.edu/programs-and-resources/rutgers-biocontainment-laboratory/
Thersa Chang PHD from the Rutgers PHRI contributed to the article published in Viuses which outlined Brilacidin's anti Covid research
https://phri.njms.rutgers.edu/faculty-and-research/faculty/theresa-chang/
Thersa Chang has published research outling defensins immune modulation attributes.
https://pubmed.ncbi.nlm.nih.gov/29501617/
Ding, J.; Chou, Y.Y.; Chang, T.L. Defensins in viral infections.J. Innate Immun.2009,1, 413–420.
Klotman, M.E.; Chang, T.L. Defensins in innate antiviral immunity.Nat. Rev. Immunol.2006,6, 447–456. [CrossRef] [PubMe
She is also credited with being an important contributor to the Viruses article including performing some of the experiments T.L.C.
Author Contributions:Conceptualization, A.B., A.N., T.L.C., W.K.W., and J.A.H.; Methodology,A.B., W.K.W., J.A.H.; A.B., K.R., N.B., F.A., and T.L.C. conducted experiments; Visualization, Formalanalysis, Data curation, A.B., A.N., W.K.W., T.L.C., and J.A.H.; Writing—original draft preparation,A.B., A.N., W.K.W., and J.A.H.; Writing—review and editing, A.B., A.N., W.K.W., and J.A.H.; Projectadministration, A.N., W.K.W., and J.A.H.; Funding acquisition, A.N., W.K.W., and J.A.H. All authorshave read and agreed to the published version of the manuscript.
GLTA, Farrell
Here's TD Ameritrade list by sticker. ERHE trading is restricted to sales only,no buys.
Late buying kicking in. It is now green.
Which brokerages allow unrestricted trading?
https://www.tdameritrade.com/retail-en_us/resources/pdf/cesecuritylist.pdf
TD Ameritrade began the same restriction today.
GTA Farrell
Spoken like a clairyoant, prophet or seer showing us the future.
If the Phase 2 study shows Brilacidin is effective my bet that is exactly what will happen not only in India, but Brazil,Japan and wherever the mutations devastate and ravage .
"A prophet is a teacher of known truth; a seer is a perceiver of hidden truth, a revelator is a bearer of new truth. In the widest sense, the one most commonly used, the title 'prophet' includes the other titles and makes of the prophet, a teacher, perceiver, and bearer of truth."
"I'm sure IPIX is on the horn right now with Indian Health Ministry and all the top Indian Pharmas"
GLTA,
Farrell
The Indian variant represents a mutation on the Corona virus S protein which attaches the virus to human cells. This is of great concern because A number of Covid treatments,eg Lilly's Bamlanivimab and Regeneron's antibody as well as convalescent serum, mechanism of action is to bind to the S protein to prevent attachment to the cells.
This may reduce the effectiveness not only of therapeutics but also vaccines
Pfizer or Moderna shots. In these studies, the antibodies could still neutralize the B.1.617 variant, but the potency of the antibodies dropped by about sevenfold on average, the authors reported.Although early studies show they can still prevent infection.
The Astra Zenica vaccine is less likely to prevent infection but
"preliminary evidence suggests this vaccine will also be able to prevent severe cases and deaths, said Rakesh Mishra, adviser to the Centre for Cellular & Molecular Biology in Hyderabad, India.
https://www.npr.org/sections/goatsandsoda/2021/05/12/995855343/will-covid-19-vaccines-still-work-against-the-variant-from-india
"B.1.617.1 has been called the “Indian double mutant”, but this term is misleading as it has around 15 mutations compared with older variants. “Double mutant” refers to the fact that it has two mutations of particular concern in the outer spike protein of the virus. These two mutations, known as L452R and E484Q, might make antibodies to older variants or existing vaccines less effective..."
"Some B.1.617.1 viruses have an additional mutation called V382L in the spike protein. This is what is meant by the term “triple mutant”."
https://www.newscientist.com/definition/indian-covid-19-variant-b-1-617/
Thanks for posting the WHO update on the Indian variant.
Alarming points:
1."Earlier this week, the WHO declared B.1.617-which counts three so-called sub-lineages with slightly different mutations and characteristics-a "variant of concern"."
2. " it appears to be transmitting more easily than the original virus, pointing to the "rapid increases in prevalence in multiple countries".
3 "the variant was more resistant to treatment with the monoclonal antibody Bamlanivimab, and also highlighted early lab studies indicating "limited reduction in neutralization by antibodies".
4" "real-world impacts" on the effectiveness of vaccines against the variant "may be limited".
5.The World Health Organization said on Wednesday a variant of COVID-19 behind the acceleration of India's explosive outbreak has been found in dozens of countries all over the world.
Brilacidin's potential triple mechanism of action would provide additional protection against Corona virus mutations if it is proven effective.
GLTA,
Farrell
Its the catch 22 of government regulations and FDA oversight. IPIX is not to blame in the study design.
Remdesivir does not work to lower Covid19 mortality or complications.
In spite of this Remdesivir was the only antiviral approved by the FDA for Covid19 and is a part of virtually every Covid 19 study{which was one of the best arguments against approving it}.
Remdesivir is considered the "standard of care" at many hospitals.
It is unethical not to provide the standard of care in Covid19 studies.
As a result Covid 19 antiviral studies in the US are currently using Remdesivir and not a placebo in clinical trials.
How can one tell if another antiviral eg Brilacidin is superior to Remdesiviir without a placebo?
Well if the Brilacidin treatment arm substantially lowers mortality or complications then one could reasonably assume Brilacidin is effective against Covid19 {remember Remdesivir does not work}.
At this point there has been no definition of the SOC in the Brilacidin phase 2 study except as defined in the local facility. It is possible Remdesivir will only be used in the US hospitals, and it appears those numbers may be small.
So that will add to the mystery.
It will be up to the wisdom of the FDA to design the phase 3 study. Will the phase 3 study include a placebo control arm without Remdesivir...
We will have to wait and see. My guess is it will not be necessary, but who knows?
GLTA, Farrell
In contrast Brilacidin may have 3 antiviral mechanisms of action. In addition it is a proven broad spectrum antibiotic and it has anti-inflammatory properties.
Brilacidin starts killing Covid 19 in the serum shortly after infusion. It does not require conversion to an active form like Remdesivir and Pfizers PF 07321332..Brilacidin is the only antiviral being studied which is viruidal. It attaches to the viral coat and destroys the virus shortly after contact.
The Pfizer drug is a prodrug, like Remdesivir, and has to be activated to its effective form.
In addition testing at the RBL demonstrated that Brilacidin prevents viral attachment to the cells.Computer simulations showed it may deactivate the virus's main protease.
Bliacidin has a number of anti-inflammatory properties which may limit the Covid 19 inflammatory cascade which leads to many complications including pulmonary failure.
It broad spectrum antibiotic may reduce the secondary infection rate in hospitalized patients which has been reported as high as 8%
Brilacidin has been successful in all of its previous studies. The Phase 2 study is soon to be fully enrolled.
GLTA,Farrell
The Pfizer Covid19 drug is a protease inhibitor. All the protease inhibitors tested to date have failed to show efficacy against Covid19.
These include the antiviral drugs. lopinavir, ritonavir, darunavir andcobicistat have been shown in clinical trials to not be effective against Covid19.
The current FDA recommendation is to not use any protease inhibitor against Covid19 in any patient:
"Recommendations
The COVID-19 Treatment Guidelines Panel (the Panel) recommends against the use of lopinavir/ritonavir and other HIV protease inhibitors for the treatment of COVID-19 in hospitalized patients (AI).
The Panel recommends against the use of lopinavir/ritonavir and other HIV protease inhibitors for the treatment of COVID-19 in nonhospitalized patients (AIII)."
https://www.covid19treatmentguidelines.nih.gov/antiviral-therapy/lopinavir-ritonavir-and-other-hiv-protease-inhibitors/
In addition lopinavir and ritonavir have significant cardiac and hepatotoxicity
The Pfiizer study is a phase 1 ascending dose trial in 60 healthy volunteers. This is the first time the drug has been used in humans.
https://clinicaltrials.gov/ct2/show/study/NCT04756531#contacts
Wonderful summary.The scene is being set for Brilacidin to enter every treatment regimen for not only Covid19, but many other viral disorders.
The lack of an effective antiviral treatment for Covid 19 may soon be over. With the poor results for other Covid19 antiviral treatments Brilacidin will move to the front of the line with postive Phase 2 results.
GLTA Farrell
I agree I have noted a change in trading over the last week.
I expect more strength as we move closer to the trial end and subsequent review.
GLTA,
Farrell
IPIX is not on the restricted trading list. Buying and selling IPIX is not limited by TD Ameritrade.
The list of restricted stocks:
https://www.tdameritrade.com/retail-en_us/resources/pdf/cesecuritylist.pdf
GLTA,
Farrell
I have received a similar email from TD Ameritrade. Fortunately IPIX is not on the exclusion "{Caveat Emptor"}list:
"The U.S. Securities and Exchange Commission ("SEC) recently approved amendments to rules regarding investor protections when trading in Over the Counter ("OTC") securities. One potential impact of these rule changes is that when current information regarding issuers' financials is not available, and/or quotations are also unavailable, such securities may be designated as Caveat Emptor ("buyer beware"). These changes have the potential to create conditions where the security is difficult to sell or trade.
Effective May 25, 2021, TD Ameritrade will restrict orders in Caveat Emptor-designated securities to liquidation only. Only closing orders will be accepted after this time and existing orders to open new positions will be canceled..."
GLTA,
Farrell
Section 1.17 and 1.66 seems to secure IPIX rights to any manipulation of the final product. My interpretation is IPIX's rights {including the royality} are secure as long as the final compound contains patented Brilacidin.
1.17 “Compound” means IPI’s proprietary molecule known as Brilacidin in the chemical structure set forth in Exhibit B, including any back-up compounds and analogues (including, prodrugs, metabolites, complexes, degradants, impurities, mixtures and other combinations) their salts, solvates, hydrates, stereoisomers, crystalline and amorphous forms, owned or Controlled by IPI as of the Effective Date or during the Term.
1.66 “Product” means any pharmaceutical product using the Formulation containing the Compound (alone or in combinations with other active pharmaceutical ingredients) in the Indication.
Section 8 covers IPIX's responsibilities to maintain and enforce its patents for Brilacidin in Alfa Sigmas territory. As long as the patents are current the 6% royality applies regardless of how Alpha Sigma compounds the Brilacidn preparation.
Nothing in the document implies Alpha Sigma's royalty to IPIX will reduced for any compound that contains patented Brilacidin.
"They've apparently developed their own compound that USES Brilacidin. Might that not lower the royalty to 2%? "
GLTA Farrell
My intuition tells me Alpha Sigma want to get their trail under way because the Brilacidin oral medication trial for ulcerative colitis is projected to start soon. They could be concerned the oral formulation will work so well the rectal preparation will be superfluous.
Glta,Farrell
Why would you think Brilacidin's safety would be an issue in this trial when it has not been a significant problem in any previous trial?
Imagine your mom presents to the hospital with an oxygen level of 88; respirations 28 a minute. Her doctor just told you her Covid swab was positive. He stated a new medicine was approved for Covid 19 which has been shown to reduce mortality and complications, but it may cause transient tingling and BP elevations?
What would you do?
Genuinely keen to hear!!!
GLTA,Farrell
That's your opinion. My opinion is an antiviral which is active against Covid,even to a mild degree, will be an important part of any treatment regimen for Covid 19.Currently none of the antivirals studied against Covid19 have shown reproducible results in lowering the mortality or complications of Covid19.
It appears we will know the results of the Phase 2 trial sooner than we thought.
Then of course the risk of being long is reduced by the potential of Brilacidin being a pan viral agent, a unique treatment for inflammatory bowel disease as well as a means of reducing the pain and irritation suffered by patients receiving cis platinum and radiation for head and neck cancer.
All of the above are reasons I bought more shares yesterday.
Glta,
Farrell
First glance of 10q is terrific. Progress on IBD and Covid19 affirms the reasons I continue to invest in IPIX.
I bought shares yesterday.
Busy all day today. Will deep dissect 10 Q later
GLTA Farrell
Terrific post. Its good to return to reality.
Good luck,
Farrell
"...make the Brilacidin a most potent drug against SARS-CoV-2 than the known antiviral drugs."
Quite a quote and in a prestigious journal, no less.
Thanks for posting\,
Farrell
"Bio-computational designed Brilacidin is a synthetic non-peptide defensin mimic drug that destabilises the viral membrane by its amphipathic & hydrophobic nature, and its immunomodulatory property influence the expression of IL-1ß, IL-6, TNF-a cytokines, and cAMP& PDE4/PDE3 pathways which are associated with bronchodilator and anti-inflammatory effects of COVID-19 disease. The smaller size, more effective antimicrobial activity, bioavailability, low enzymatic degradation and toxicity, natural and low-cost production make the Brilacidin a most potent drug against SARS-CoV-2 than the known antiviral drugs."
Good thought. The first thing that came to my mind was a statistical blip due to differences in SOC at different hospitals, but who knows.
GLTA,
Farrell
If you had been paying attention you would realize all the antiviral being tested for moderate to severely ill Covid19 patients have failed to reduce mortality or complications of Covid 19. These medications include Remdesivir, Favipiravir, Molunpiravir,Regeneron's and Lilly's monoclonal antibodies and others.
Now many of these medications are being tested in the mild Covid patients to see if they reduce the chance of progression to moderate or severe disease.
Will the Pfizer pill for Covid19 be effective when other IV protease inhibitors, lopinavir and ritonavir, have completely failed?
Brilacidin is being tested for the as a Covid 19 antiviral for the moderate to severe disease patients. If it is successful it will have virtually no competition. Most moderately to severely ill patients ideally should have a antiviral as a part of their therapeutic regimen.
As you should know Brilacidin has advantages over all the antivirals studied to date. It is the only virucidal antiviral. It begins killing Covid in the serum, extracellular space and inside the cells on contact. Its is active immediately where many of the other drugs such as Remdesivir have to be converted to an active form inside the cells. It is the only well documented anti-inflammatory antiviral. Brilacidin may possess a triple antiviral mechanism of action. It shreds the viral capsid, prevents viral cellular attachment and may be active against the main protease to prevent viral reproduction. It is a broad spectrum antibiotic with activity against most Gram positive bacteria including MRSA as well as some gram negative bacteria which will reduce the chance of secondary infections such as pneumonia and septicemia in these ill patients.
It should be obvious that the vaccines are never going to be 100% effective, Covid mutates frquently reducing the effectiveness of the vaccines and millions of individuals will never take the vaccines.
It is also obvious Covid19 with its deaths and side effects is not going away even with vaccines and preventative treatments.
Unfortunately a market for an effective Covid19 antiviral is going to be needed because death and morbidity from Covid is going to be with us .
GLTA Farrell
The best known protease inhibitors for Covid19 are Lopinavir and Ritonavir they failed a well done clinical trial for Covid19. Most approved protease inhibitors are used for AIDS.
"In patients admitted to hospital with COVID-19, lopinavir–ritonavir was not associated with reductions in 28-day mortality, duration of hospital stay, or risk of progressing to invasive mechanical ventilation or death. These findings do not support the use of lopinavir–ritonavir for treatment of patients admitted to hospital with COVID-19."
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32013-4/fulltext
GLTA Farrell
I agree. I look for more help if the Phase2 trial produces positive results.
Grants, partnership offers, expedited trials, EUA or at least expanded compassionate use. I hope we can do something for India soon.
Just a few weeks away.
GLTA,Farrell
News 50% enrollment achieved.
GLTA,Farrell
Thanks for posting. I missed that nugget in the 10q.
Of course more benefits for the BOD means more responsibility and time.
What could that mean?
GLTA,
Farrell
So far the "India connection" brings up more questions than answers.
I could speculate all day , but if you know something now is the time to come clean.
Help us out.
GLTA,Farrell
Many individuals across the country are concerned about the side effects of the vaccines and the economic effects of mitigation. Are you stating Michigan is more concerned than other states? My guess is vaccine rates in Michigan will be in the middle of the other states in vaccine rates. We will see if any one can dig out up to date
state statistics.
Glta, Farrell