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Ha Ha... best answer yet,
In other words in the entire cosmos using the best "science" known to man it is immeasurable like a vapor, faint smell or flash of insight.
I sure Mako wishes that was the simple truth. I am afraid the reality may prove different.
GLTA,Farrell
The good news is the bar for success is incredibly low. Brilacidin only has to be 2% better than Remdesivir for it to be the antiviral drug of choice for covid.
We should know the phase2 results very soon.
GLTA,
Farrell
That begs the question of how do you you would accurately determine naked shorts since:
A. Naked short selling is illegal. If we could measure naked shorting it seems reasonable we could prosecute and jail the offenders, but legal action seems infrequent at best.
B. The most efficient naked shorts collude with conspirators internationally to evade detection. Although Mako was recently accused of this in the Mako Research vs Abeona Therapeutics legal action, it is my understanding it is difficult to prove.
How would you suggest we measure the illegal naked shorts?
This is pertinent to IPIX since IPIX and Mako were involved in a legal action.
GLTA,Farrell
Nice thread. It is interesting to review the FDA online documents, but they can be inconsistent and confusing.
It is not confusing that the FDA has approved a number of covid treatments and vaccines for compassionate use.
We are fortunate to have a practical example of how the FDA awards compassionate use as well as extended compassionate and emergency use for a covid antiviral medication, remdesivir
Remdesivir was initially used for compassionate use in Jan of 2020.
Then in May of 2020 remdesivir was approved for emergency use after an interim review of its adaptive phase2-3 trial suggested some benefit.
"... the National Institute of Allergy and Infectious Diseases (NIAID) double-blinded placebo trial NCT04280705, reported that remdesivir was superior to placebo in speeding up the recovery time in COVID-19 patients [34]...However, from these preliminary data, the Food and Drug Administration (FDA) on 1 May 2020, approved its emergency use for patients at all ages requiring or not requiring invasive ventilation or ECMO [4]. Consequently, the European Medicines Agency (EMA) on 11 May 2020 revised the recommendations for compassionate use of remdesivir by extending the inclusion criteria with the addition of patients who do not require invasive ventilation to be treated for a period of 5 days through 10 days
https://joppp.biomedcentral.com/articles/10.1186/s40545-020-00258-8
If Brilacidin's phase 2 clinical trial shows substantial benefit in the moderate to severe covid patients it will be the only antiviral to demonstrate such efficacy and will have a virtual lock on the pathway to emergency use utilization and likely approval.
Of course the skepticism regarding Remdesivir's effectiveness proved well founded as subsequent studies by WHO and others questioned not only its efficacy, but irregularities to its path to approval.
https://www.science.org/content/article/very-very-bad-look-remdesivir-first-fda-approved-covid-19-drug
https://www.covid19treatmentguidelines.nih.gov/management/clinical-management/hospitalized-adults--therapeutic-management/
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2781959
The current NIH Covid 19 treatment guidelines from Aug 2021 state:
"Rationale for the Panel’s Assessment That There Is Insufficient Evidence to Recommend Either for or Against the Use of Remdesivir"
We should know the Brilacidin results very soon.
GLTA, Farrell
A terrific phase 2 for Brilacidin will be a career changer for many if the results are positive.
Glta,Farrell
Evonik is an international company with several production facilities in the USA:
Allentown, Pennsylvania
Function: Office, Research & Development
Birmingham, Alabama
Function: Production, Research & Development
Blair, Nebraska
Function: Production
Calvert City, Kentucky
Function: Production
Charleston, South Carolina
Function: Production
Chester, Pennsylvania
Function: Production
Deer Park, Texas
Function: Production
Etowah, Tennessee
Function: Production
Garyville, Louisiana
Function: Production
Greensboro, North Carolina
Function: Office, Production, Research & Development
Havre de Grace, Maryland
Function: Production, Research & Development
Hopewell, Virginia
Function: Production
Horsham, Pennsylvania
Function: Office, Research & Development
Janesville, Wisconsin
Function: Production
Lafayette, Indiana
Function: Production, Research & Development
Los Angeles, California
Function: Production
Mapelton, Illinois
Function: Production
Milton, Wisconsin
Function: Production
Mobile, Alabama
Function: Office, Production
Parisppany, New Jersey
Function: Regional Headquarters Evonik Region North America
Pasadena, Texas
Function: Production
Piscataway, New Jersey
Function: Research & Development
Reserve, Louisiana
Function: Production
Richmond, Virginia
Function: Office, Research & Development
Waterford, New York
Function: Production
Weston, Michigan
Function: Production
Wichita, Kansas
Function: Production
Regional Website
North America
https://corporate.evonik.com/en/company/locations/north-america
Leo is letting the interested parties know he can go it alone if he needs to. The stock options give him the ability to attract top notch administrative talent to manage Brilacidins success.
Does Leo want to go it alone or is it a negotiating strategy? We should know very soon.
Glta,
Farrell
Another excellent point.
GLTA, Farrell
It is a bit of corporate house cleaning before the well heeled visitors arrive for a profitable visit.
Expect more news soon.
I agree with your perceptive comments.
"The company is expecting stellar results. There may already be a contingent offer on the table for either partnering or full company buyout. If full buyout is on the table, then the purchasing company would want and need to know what the full outlay will be since all the shares would need to be acknowledged prior to final purchase price/payment was announced.
Just my reading of the “Setting the Table” prior to a huge announcement is my opinion. Hopefully for all the Longs on this board, we see it come to fruition."
GLTA, Farrell
Expanded access and compassionate use tab now on IPIX web-site.
http://www.ipharminc.com/expanded-access-and-compassionate-use
Good luck,
Farrell
Nice review. The only point I would add is some severe ill covid patients can not respond to the infection and have a persistent viremia. Your point about the anti-inflammatory effects of brilacidin are well taken. The antiviral and anti-inflammatory effects of Brilacidin make it unique.
Glta, Farrell
Regeneron's antibody treatment flunked its treatment for moderate to severe covid( as did every over antiviral).
Yes, it is an emergency.
Glta, Farrell
Just remember there is absolutely no evidence hedge funds are manipulating IPIX, absolutely none.
Glta,Farrell
My guess is the EUA request will be rejected. Then Merck will complete the current study plus perform additional animal studies.
The last thing the FDA and politicians want is to be a part of the next thalidomide disaster.
Glta,Farrell
Thanks for posting. Moderators, this post should be placed at the top.
GLTA,
Farrell
Mutagenic effects include DNA damage which could result in increased rates of malignancy later in life.
Birth defects can be mitigated with contraception. Unfortunately many women use contraception intermittently and do not know they are pregnant the first few weeks of pregnancy,the period where birth defects are most likely to occur.
Glta,
Farrell
Scientific report outlines the risk of gene mutations with Molnupiravir.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8344773/pdf/jiab363.pdf
"This leads to the conclusion
that treatment with molnupiravir will lead to mutations in host DNA in dividing cells.
Using negative results to justify this risk as being unimportant is to create a blind
spot for potential long term harm. Until a better understanding of treatment with
molnupiravir is achieved, we would argue that its use should be limited to people
with co-factor risks for COVID who are likely to receive the greatest benefit while
being exposed to the unknown long term risks of exposure to this mutageupiravir explained"
GLTA, Farrell
"Merck isn’t simply going to get a pass on this from the FDA."
Zero hedge expressed serious concerns about Molnupiravir.
https://www.zerohedge.com/news/2021-10-01/mercks-therapeutics-waiting-wings-faucis-removal
"Today news of Merck's Molnupiravir is dominating the narrative. In dramatic fashion they are stopping the trial recruitment and plan to file an EUA. While this is fantastic news people can’t be blinded by the Merck aura and have to dig into the news to truly understand the ramifications. This is a drug with known mutagenicity. Ironically Merck’s inclusion criteria in ALL their clinical trials required participants to not have sex. This includes the clinical trial for prophylaxis. Perhaps they want to avoid the potential of birth defects so this drug is clearly not going to appeal to anyone building a family or engaging in intercourse.
The drug is using the virus’s propensity to mutate against itself by tricking the replication machinery to pump out reproduction errors until the virally infected cell collapses. The last thing the FDA wants to do is approve a drug that brings the rise of a new class of variants. It's unclear if Merck tested patients for new variants that are more likely to rise up in patients who have the longest active infections. Merck isn’t simply going to get a pass on this from the FDA. Based on the commentary in the Merck press release it's unclear if Merck even knows if their drug is safe. Essentially they talk about the incidence of drug-related adverse events as the same, but didn’t provide any color on what these events were.
"The euphoria from this news announcement isn’t looking at the fine print of the trial design of the study. Recruitment required at least one underlying medical condition like obesity, old age (>60 years), diabetes, or heart disease. Looking at this patient population was needed to obtain statistical significance because too many with no underlying conditions just get better on their own. The trial could have been a failure otherwise. Another factor contributing to Merck's success is a smaller than expected stratification of Delta variant infections. Only 40% of the clinical trial had Delta variant patients. People need to consider that a majority of the data was from the alpha variant which means that if Merck doesn't segregate the data by variant they are trying to pull the wool over our eyes to hide how weak the data really is."
GLTA,
Farrell
Thanks for posting. Interesting data which clearly outlines the deficiencies of current covid vaccines. Many studies use medicare data.
Another reason to increase the development of therapeutics like Brilacidin.
GLTA,
Farrell
Here is the whole quote with 2 additional reports.
"Based on an interim analysis of data from the phase 2, dose-finding portion (Part 1) of 2 ongoing phase 2/3 trials evaluating molnupiravir, Merck and Ridgeback Biotherapeutics have decided to halt the MOVe-IN study for hospitalized COVID-19 patients and proceed with the phase 3 portion (Part 2) of the MOVe-OUT study in outpatients with COVID-19"
https://www.empr.com/home/news/molnupiravir-merck-ridgeback-oral-antiviral-investigational-covid-19-treatment/
The pill known as molnupiravir reduced virus levels in patients during a mid-stage study but didn’t show a meaningful benefit in preventing hospitalizations and deaths, the Kenilworth, New Jersey-based company said in a statement. It decided to discontinue its development for the sickest patients, those hospitalized with the infection, after the trial showed it was unlikely to help them.
https://www.bloomberg.com/news/articles/2021-04-15/merck-setback-limits-study-of-covid-pill-to-treat-milder-disease
Merck MRK 8.37% & Co. and its partner Ridgeback Biotherapeutics LP said they are stopping a trial of their experimental Covid-19 drug after it failed to help hospitalized patients, delivering another setback to doctors seeking treatments to use for the disease.
https://www.wsj.com/articles/merck-partner-halt-covid-19-treatment-trial-for-hospitalized-patients-11618483561
This portion of the quote is incorrect.
...after the FDA asked for additional information.
Merck released the stories about MK7110 the oncoimmune anti-inflammatory drug and EIDD-2810 about the same time and the announcements were in the same articles.
Thanks for the correction.
Farrell
A scientific article also demonstrated mammalian cell DNA toxicity to molnupiravir which could induce birth defects or cancer in the host.
"SARS-CoV2 infection results in an age-related acute respiratory disease spectrum that can be life-threatening, especially in the elderly and individuals with select underlying comorbidies [14]. rNHC (initial metabolite of molnupiravir} has the potential to have therapeutic benefit in this setting. However, there are risks for the host in that the same mutagenic activity that impacts viral replication has the potential for incorporation and mutagenesis of host DNA. This risk can be inferred based on the common intermediate of the ribonucleoside diphosphate shared in the synthesis of both ribonucleoside triphosphates and 2'-deoxyribonucleoside triphosphates. The concern would be that mutations in host DNA could contribute to the development of cancer, or cause birth defects either in a developing fetus or through incorporation into sperm precursor cells. We take this as evidence that in exposing the viral population to mutagenesis in its RNA form, the host is likely to be exposed in its DNA form. It seems unlikely that a short course of therapy would spare the host from this exposure because both RNA precursors that affect the virus and DNA precursors that would affect the host pass through the common ribonucleoside diphosphate intermediate.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8136050/
GLTA,
Farrell
That is correct. No covid antiviral has been found to be successful treating moderate to severe hospitalized covid patients.
Anther reason brilacidin could be unique.
farrell
In addition concerns about safety Ridgeback has been accused of manipulating safety data as well as government safety for the advancement of Molnupiravir.
"The Bright allegation addressed by Benford's email centers on a so far unsuccessful effort by Florida-based Ridgeback Biotherapeutics to win new federal funding to develop EIDD-2801, a version of a 4-decade-old antiviral drug, into a treatment for COVID-19. Although the drug has shown potential against the coronavirus that causes the disease, Bright had opposed providing an immediate large funding boost. He argued the drug had already received substantial government support, and some earlier studies suggested EIDD-2801 could cause harmful genetic mutations. In his complaint, Bright suggests Kadlec attempted to help Ridgeback sidestep a government contracting process that is supposed to be guided by science. In one email to BARDA, a Ridgeback executive wrote that Kadlec was "personally" pushing the company "to move fast, but we can't without this authorization" for funding."
https://www.science.org/news/2020/05/emails-offer-look-whistleblower-charges-cronyism-behind-potential-covid-19-drug
https://www.washingtonpost.com/business/2020/06/11/coronavirus-drug-ridgeback-biotherapeutics/
Plus a shadow of birth defects as well as genetic damage hangs over this class of drug and Molnupiravir itself.
This is the controversy that led to Rick ?Bright leaving the government
" EIDD-2801 {Merck's Molnupiravir} has been viewed as a potential competitor to remdesivir, although a contentious one, because similar compounds are mutagenic in animal studies, meaning they produce birth defects. Rick Bright, who was removed from his position as head of the US Biomedical Advanced Research and Development Authority (BARDA) in April, was reluctant to provide funding for the drug for this reason, according to an 89-page whistleblower complaint Bright filed after being fired. Merck’s investment in EIDD-2801 can be seen as a vote of confidence in the compound.
Bright’s concerns began in November 2019, more than one month before China disclosed the first COVID-19 cases in Wuhan — ScienceMag has that story:
Raymond Schinazi, an Emory University chemist who has extensively studied the active ingredient in EIDD-2801 but has no connection to DRIVE, notes that his former pharmaceutical company, Pharmasset, abandoned it in 2003 after discovering its mutagenic properties. Schinazi says the small chemical tweaks made to increase the ingredient’s bioavailability and transform it into EIDD-2801 are unlikely to change its mutagenicity. “Thank goodness someone is raising the red flag,” about EIDD-2801, Schinazi says. “You don’t develop a drug that’s mutagenic. Period.”
" Merck’s Research Labs President Roger Perlmutter addressed the lingering questions about the drug’s mutagenic side-effects during the earnings call and explained what the company is doing to address safety concerns, a transcript of which is available at this link.
First of all, for the MK-4482, as you know, the compound is Ames positive. That’s, in a way, not unexpected given its mechanism of action. It is a cytosine analog so that — one could expect to see those kinds of things. The question is, does the compound have mutagenic activity that’s meaningful in mammalian cells and what do we want to do about this. Ordinarily, of course, we don’t want to take mutagens forward into clinical practice, although it has been done where the benefit/risk profile makes sense"
What does it mean to be Ames positive?:
The Ames test is a widely employed method... it is a biological assay to assess the mutagenic potential of chemical compounds.[1] A positive test indicates that the chemical is mutagenic and therefore may act as a carcinogen, because cancer is often linked to mutation. The test serves as a quick and convenient assay to estimate the carcinogenic potential of a compound...
THe positive Ames test and documented birth defects in similar compounds as document by Dr Bright must be thoroughly addressed.
https://bgr.com/2020/07/31/coronavirus-cure-merck-mk-4482-eidd-2801-rick-bright-controversy
https://en.wikipedia.org/wiki/Ames_test
GLTA Farrel
from post 351726
Ridgeback's Molnupiravir failed its cliniacal trial for hospitalized patients with moderate to severe covid.It was halted by Merck after the FDA asked for additional information.
https://www.empr.com/home/news/molnupiravir-merck-ridgeback-oral-antiviral-investigational-covid-19-treatment/
The current possible indications for Molnupiravir will be limited to prophylaxsis and early mild to moderate non hospitalized covid.
https://www.merck.com/news/merck-and-ridgebacks-investigational-oral-antiviral-molnupiravir-reduced-the-risk-of-hospitalization-or-death-by-approximately-50-percent-compared-to-placebo-for-patients-with-mild-or-moderat/
Brilacidin's clinical trial is for hospitalized patients with moderate to severe covid...
the trial Molnupiravir failed.
GLTA,
Farrell
The Israeli data shows a different story.
"Yet, despite the wide vaccination campaign and its initial dramatic impact, since mid-June, a
new surge has been observed in several highly-vaccinated countries, including Israel. This
increased infection rate, and especially the increased rate of BTI, can be attributed to two
separate factors: waning of the vaccine induced immune response, and/or inherently lower
immune response against the Delta variant (B.1.617.2)15–17, which became the dominant variant
during the current surge. "
Most of the new infections were in the vaccinated.
Crossing this
dataset with vaccination data, we identified in total 1,910 infections of unvaccinated, 9,734 BTI
of 2-dose-vaccinated and 245 BTI of booster-vaccine.
https://www.deseret.com/coronavirus/2021/7/20/22584134/whats-going-on-in-israels-outbreak-among-vaccinated-people
The English data also confirms double vaccination does not eliminat the risk of hospitalization and death with the delta variant:
https://www.msn.com/en-gb/health/medical/nearly-30percent-of-those-dying-with-delta-variant-of-covid-are-double-vaccinated/ar-AAL1RQE
The one in 5000 rate of break through infections reported by the New York Times is not consistent with rates of hospitalization among the vaccinated with the delta variant in the US.It is not consistent with international reports. It ignores the fact with delta USA and international studies show as high of 40% of the new covid infections and 15-20% of the deaths occur in the vaccinated
The author of the study quoted by the NYT has made assumptions that have been widely criticized.
https://slate.com/technology/2021/09/breakthrough-infections-one-in-five-thousand-nonsense.html
"I think those are numbers that are manipulated that don't take into the context of everyone who's asymptomatic," said {Dr}Lindquist.
https://www.kptv.com/news/doctors-in-oregon-and-washington-cast-some-doubt-on-new-york-times-breakthrough-case-report/article_4c30c944-11c1-11ec-85bd-cb80ae09184a.html
"So why does the one-in-5,000 figure seem implausible? Methodologically, it’s because the CDC stopped tracking “mild” breakthrough infections months ago and many vaccinated people probably aren’t bothering to get tested anymore."
https://hotair.com/allahpundit/2021/09/07/odds-of-a-breakthrough-infection-just-one-in-5000-n414199
Last from MIT:
Breakthrough infections are usually mild or asymptomatic. But there’s a lot we still don’t know. For example, because the CDC is now tracking only breakthrough cases requiring hospitalization, we don’t know how often mild, breakthrough infections can result in symptoms of long COVID, though individual cases have been reported.
What we do know is that breakthrough infections with the Delta variant are more likely to be transmitted to others. A study of vaccine breakthrough in more than 100 Indian healthcare workers showed that those who became infected with the Delta variant had higher respiratory viral loads compared to those with non-Delta infections. The latter were unlikely to transmit the virus to anyone else (average cluster size 1.1), while those infected with the Delta variant transmitted the virus, on average, to more than two of their coworkers (average cluster size 3.3).
Real-world data also demonstrates the ease with which vaccinated people can spread the Delta variant. For example, two large clusters in Singapore began with fully vaccinated individuals who had only mild, cold-like symptoms: A fully vaccinated 46-year-old nurse at Tan Tock Seng Hospital was at the center of a cluster that swelled to 40 cases. A cluster of more than 100 began with an 88-year-old, fully-vaccinated janitor at Changi Airport. In both of these clusters and others in the Singapore outbreak, the virus was passed to, and from, both unvaccinated and vaccinated individuals. This can be clearly seen in a visualization of clusters comprising 897 cases during a two-month period.
https://medical.mit.edu/covid-19-updates/2021/07/deltas-here
GLTA,Farrell
Hopefully we will get better data regarding delta covid infections.
IPIX might be better off employing lobbyists than funding more studies. It is hard to compete with Big pharma and their connections.
It is puzzling such a promising antiviral as Brilacidin has to squeak so slowly through the clinical studies.
Where is the money all the politicians have promised?
GLTA,
Farrell
I agree.
"It could easily be interpreted to say that this thing (pandemic / virus) will go through society at its own pace, infecting both the vaccinated and unvaccinated the same way
initially (though lower chance of being infected if vaccinated). I do believe vaccination will save people from severe disease, but that's about all one can say for SARS2-delta infection, at least based on this study. Would like to see more data on SARS2-delta hospitalizations and severe disease based on vaccination status.
Some experts, including UK's Oxford Vaccine Group, have stated the only end to the pandemic and achieve herd immunity will be when the unvaccinated and vaccinated have been infected and achieve "natural immunity"
https://www.theguardian.com/world/2021/aug/10/delta-variant-renders-herd-immunity-from-covid-mythical
Others question the wisdom of vaccinating children.
https://khn.org/news/article/covid-vaccination-children-rare-side-effects-myocarditis-experts-caution/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8437699/
I agree there is little US data on delta complications and vaccine complications. The best data has come from the UK and Israel.
Unfortunately the vaccines do not work as well as we had hoped against the delta variant. As long as the vaccinated can catch covid 19 and spread it there is little hope for herd immunity. It is clear vaccination is a benefit to the elderly and high risk individuals. It is less clear what benefit will come from vaccinating healthy children and young adults.
With those observations developing therapeutics should be a high priority.
Hopefully Brilacidin will prove useful against covid19.
GLTA,
Farrell
Immunocompromised patients have been reported to have persistent covid viremia for months.
Another reason Brilacidin is needed for covid.
file:///C:/Users/djones/AppData/Local/Temp/viruses-13-01025-v2.pdf
https://academic.oup.com/ofid/advance-article/doi/10.1093/ofid/ofab217/6257145
GLTA,Farrell
Even better news is Brilacidin for Covid19 has past 2 FDA safety checks in its Phase 2 clinical trial.
Brilacidin's safety is not an issue.
GLTA,
Farrell
Terrific review.Thanks for posting.
GLTA, Farrell
Then we can agree drive through vaccine administration is a horrible idea.
Glta, Farrell
Thanks for sharing the information. I am hoping for a complete recovery. Perhaps more good news soon.
GLTA,Farrell
Anaphylaxis is a life threatening allergic reaction. If it is not treated immediately it can be fatal. It is not a trivial condition.
"Anaphylaxis is a severe, potentially life-threatening allergic reaction. It can occur within seconds or minutes of exposure to something you're allergic to, such as peanuts or bee stings.
Anaphylaxis causes your immune system to release a flood of chemicals that can cause you to go into shock — your blood pressure drops suddenly and your airways narrow, blocking breathing. Signs and symptoms include a rapid, weak pulse; a skin rash; and nausea and vomiting. Common triggers include certain foods, some medications, insect venom and latex.
Anaphylaxis requires an injection of epinephrine and a follow-up trip to an emergency room. If you don't have epinephrine, you need to go to an emergency room immediately. If anaphylaxis isn't treated right away, it can be fatal."
Glta,
Farrell
https://www.mayoclinic.org/diseases-conditions/anaphylaxis/symptoms-causes/syc-20351468
New vaccine resistant variant Covid reported in US,R.1
GLTA.
Farrell
https://www.medscape.com/viewarticle/959332?uac=144876AG&faf=1&sso=true&impID=3662651&src=WNL_trdalrt_210924_MSCPEDIT_covid
"Deadline, citing a CDC report, said 26 residents and 20 workers tested positive for COVID-19 at a skilled care nursing home. The facility has 83 residents and 116 employees.
On March 1, 28 specimens that had been subjected to whole genome sequencing were found to have "mutations aligning with the R.1 lineage," Deadline said.
About 90% of the facility's residents and 52% of the staff had received two COVID vaccine doses, the CDC said. Because of the high vaccination rate, the finding raises concerns about "reduced protective immunity" in relation to the R.1 variant, the CDC said.
However, the nursing home case appears to show that the vaccine keeps most people from getting extremely sick, the CDC said. The vaccine was 86.5% protective against symptomatic illness among residents and 87.1% protective for employees.
Compared with unvaccinated persons, vaccinated persons had reduced risk for SARS-CoV-2 infection and symptomatic COVID-19," the CDC said. The vaccination of nursing home residents and health care workers "is essential to reduce the risk for symptomatic COVID-19, as is continued focus on infection prevention and control practices," the CDC said."
If IPIX begins a clinical trial for the Brilacidin inhaler,it would come after Brilacidin's efficacy has been shown for Covid19.At that time IPIX or its partner should have adequate funds to expedite the trial.
I doubt it would take 20 months.
Remdesivir completed their trial for an inhaler for covid in 8 mos
https://clinicaltrials.gov/ct2/show/NCT04539262
GLTA Farrell
At the hospital or home either could be good news. Receiving Brilacidin means the patient had exhausted all other treatment possibilities.
"Expanded Access was implemented by the FDA and Congress to address physician applications for access to potentially lifesaving drugs, prior to FDA approval, for patients in their care when available treatment options have failed. Following receipt of such requests, the Company has supplied Brilacidin to relevant hospitals for individual patient use, with the FDA granting the treating physician permission for the emergency administration of Brilacidin."
GLTA Farrell
I am also excited about the in vitro
success against adenovirus. Even though adenovirus infections are rarely dangerous infections, they are a common cause of upper respiratory infection and can result in adverse economic effect due to lost work time.
No pharmaceuticals have ever been effective against adenovirus except in the severely immunocomprimised where IV ribavirin has been used.Pharmaceutical companies may have an interest in a better treatment for this common infection.
Ipix has recognized the potential for Brilacidin as an antibiotic inhaler and has discussed the possibility of developing an inhaler for the treatment of human diseases. A number of disorders could possibly be studied :bacterial pulmonary disorders such as bronchitis bronchiectasis, emphysema as well as cystic fibrosis perhaps even sinusitis; viral disorders like coronavirus and adenovirus. In addition Brilacidin's anti-inflammatory capabilities may prove effective against asthma and other inflammatory pulmonary disorders.
If those disorders can be improved by Brilacidin the economic potential would be significant.
In addition adenoviruses are non-enveloped DNA viruses. The previous viruses Brilacidin has shown in vitro sensitivty to have been enveloped RNA viruses. At this point we will have to wait until the mechanism of action is determined, but it may be an additional mechanism not previously not associated with Brilacidin.
The importance of this finding is Brilacidin may be effective against many more viruses than originally thought possible.
List of DNA viruses and human disease:
https://www.sciencedirect.com/topics/biochemistry-genetics-and-molecular-biology/dna-virus
List of non-enveloped and enveloped viruses:
https://en.wikipedia.org/wiki/Viral_envelope
It was a great update today. Remdesivir received a designation of expanded compassionate use after its phase 2 results which led to its adaptive expedited phase 3 trial with EUA after the phase 3 interim report.
Could Brilacidin be on the same track? We will know more in a few weeks.
GLTA,
Farrell
Most of your questions would be have to be answered by the clinical trial.
The hope would be the nasal spray would kill the virus on contact and reduce the symptoms of infection.The dose and frequency would be studied in the trial.
Intranasal systemic absorption is a possibility. For example insulin is a short peptide and has been approved for intranasal use.
It is unlikely the nasal application would be effective for patients with moderate to severe Covid. If it proves to be effective it would be in patients exposed to covid,high risk patients or patients with early infection to prevent progression.
Adenoviral infection generally causes mild infections, but have an enormous economic impact in terms of days off work and productivity.An effective treatment which returned patients to work would be very valuable in my opinion.
GLTA,
Farrell
Brilacidin inhaler needed for Adenovirus. IMO a certain additional clinical trial for a valuable indication:
From CDC
https://www.cdc.gov/adenovirus/about/symptoms.html
Adenoviruses can cause a wide range of illnesses such as:
common cold or flu-like symptoms
fever
sore throat
acute bronchitis (inflammation of the airways of the lungs, sometimes called a “chest cold”)
pneumonia (infection of the lungs)
pink eye (conjunctivitis)
acute gastroenteritis (inflammation of the stomach or intestines causing diarrhea, vomiting, nausea and stomach pain)
Less common symptoms of adenovirus infection include
bladder inflammation or infection
neurologic disease (conditions that affect the brain and spinal cord)
Adenoviruses can cause mild to severe illness, though serious illness is less common. People with weakened immune systems, or existing respiratory or cardiac disease, are at higher risk of developing severe illness from an adenovirus infection.