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.

FWIW a golden cross today appeared on the ERHE stock chart. Its significance on a double zero stock is up for debate.

What's not debatable is the 8K 's effect on the stock which has cardioverted ERHE back to life. It is still sick ,but breathing.

Anyone willing to speculate about what a deal for EEZ block 4 would do for the stock?

Good luck,

Farrell

We are both speculating because we do not have data from the trial yet,but the Lancet study should be similar to the Brilacidin for Covid in many ways.

https://www.thelancet.com/action/showFullTableHTML?isHtml=true&tableId=tbl1&pii=S1473-3099%2821%2900485-0

From the Lancet study you can see general trends which should be similar to the brilacidin for covid study:

Average age was about..... 64

Males were more affected than females..... greater than 2 to 1

Coexisting conditions ....73 percent had 1 to 3 coexisting medical problems

Take another look at the numbers from the Lancet trial:

Obesity 278 (34%) 138 (34%) 140 (34%)
Chronic cardiac disease 229 (28%) 111 (27%) 118 (28%)
Diabetes 217 (26%) 104 (26%) 113 (27%)
Chronic pulmonary disease 146 (18%) 71 (17%) 75 (18%)
Chronic kidney disease stage 1 to 3 51 (6%) 19 (5%) 32 (8%)
Auto-inflammatory disease 41 (5%) 17 (4%) 24 (6%)
Malignant haemopathy 35 (5%) 16 (4%) 19 (5%)
Chronic neurological disorder including dementia 34 (4%) 18 (4%) 16 (4%)
Mild liver disease 30 (4%) 15 (4%) 15 (4%)
Active malignant neoplasm 28 (3%) 13 (3%) 15 (4%)
Transplantation 11 (1%) 2 (<1%) 9 (2%)
Asplenia 4 (<1%) 1 (<1%) 3 (1%)
AIDS/HIV not on ART

Those are obviously serious coexisting conditions.

It is clear patients with significant but stable medical problems were included in the Lancet trial.

Another point is the coexisting conditions in the predominantly Russian study population should be much higher in the western Europeans in the Lancet study. The average life expectancy in Russia is 72.6 years Belgium is 81.6 years.Russians are in poorer health.

The Lancet study data suggests most people in the brilacidin study will also have coexisting conditions.It is also clear in the brilacidin trial patients with many medical conditions will not be excluded if they are medically stable. Managing the coexisting conditions is inherent to the trial.

GLTA,

Farrell

If this isn't seriously ill, what is?

From your post:

"Inclusion criteria...

Currently hospitalized and requiring medical care for COVID-19.

Moderate OR severe COVID-19, defined by respiratory function at screening, as below:

Moderate, meets at least one of the following criteria:
Peripheral oxygen saturation SpO2 > 93% on room air;
Respiratory rate ≥ 20 to < 30 breaths per minute.

Severe, meets at least one of the following criteria:
Peripheral oxygen saturation SpO2 ≤ 93% on room air OR arterial oxygen partial pressure (PaO2) / fraction of inspired oxygen (FiO2) < 300mmHg (1mmHg=0.133kPa) [corrective formulation should be used for higher altitude regions (over 1000m)];
Respiratory rate ≥ 30 breaths per minute"

...most were older with significant comorbities."

Patients with mild to moderate renal and hepatic disease were allowed in the trial even though they are at risk of becoming worse with Covid 19.

Hypertensive patients with controlled BP on medication were allowed in the trial.

Only patients with severe uncontrolled hypertension are excluded:

"Hypertensive urgency (e.g., SBP >220 mmHg or DBP >120 mmHg) or hypertensive emergency within the last 72 hours..."

In other words stroke level hypertension was excluded

No exclusion listed for the following:
cancer patients, heart disease, asthma, Chronic obstructive pulmonary disease, epilepsy,diabetes, AIDS not requiring treatment,neurologic disorders,dementia, hematologic disorders, gastrointestinal disorders and most other chronic disorders which were well controlled.

Most of the rest of the exclusions are easily understandable

Individuals on ventilators and ECMO are excluded
Requiring systemic anti-infective therapy for suspected or confirmed active bacterial/fungal/viral systemic infection other than COVID-19.
Any serious medical or psychiatric condition or test abnormality(ies) that, in the investigator's judgment, puts the participant at significant risk, could confound the study results, or may interfere significantly with the subject's safe participation in and completion of the study.
Pregnancy or breast-feeding, or positive urine or serum pregnancy test in a pre-dose assessment.
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception throughout the study and for up to 30 days after stopping treatment.

This study of other antiviral Covid treatments was discussed recently on the board. It is a good example of patients allowed in covid clinical trials:

https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00485-0/fulltext#coronavirus-linkback-header

Obesity 278 (34%) 138 (34%) 140 (34%)
Chronic cardiac disease 229 (28%) 111 (27%) 118 (28%)
Diabetes 217 (26%) 104 (26%) 113 (27%)
Chronic pulmonary disease 146 (18%) 71 (17%) 75 (18%)
Chronic kidney disease stage 1 to 3 51 (6%) 19 (5%) 32 (8%)
Auto-inflammatory disease 41 (5%) 17 (4%) 24 (6%)
Malignant haemopathy 35 (5%) 16 (4%) 19 (5%)
Chronic neurological disorder including dementia 34 (4%) 18 (4%) 16 (4%)
Mild liver disease 30 (4%) 15 (4%) 15 (4%)
Active malignant neoplasm 28 (3%) 13 (3%) 15 (4%)
Transplantation 11 (1%) 2 (<1%) 9 (2%)
Asplenia 4 (<1%) 1 (<1%) 3 (1%)
AIDS/HIV not on ART
Most moderately to severe covid patiets are older and many have other significant disease.


GLTA,

Farrell

One of the most common problems in foreign clinical trials are computer issues. Each hospital computer software may be different, all the data has to be converted to the software system used by the CRO or data managers. The conversion can be very time consuming.

Another issue is incomplete data. All the patients in the trial were seriously ill most were older with significant comorbities. It was important for the medical staff to manage their problems whether it was ischemic heart disease, liver and kidney problems,cancer. emphysema,asthma etc. That may mean a test may not have been done in the needed time frame or it was done but not recorded. Remember the primary responsibility for the hospital and its medical staff is to care for each individual patient ,the study will always be second.

Covid infections in chronically ill patients can not be treated like they are stamping out identical car parts,they are all going to be different and require individual intensive medical
attention to their pre existing as well as the acquired medical problems from Covid.

The other issue is IPIX is a small company with limited resources. It is not going to be able to complete a study the same way Gilead or Regeneron can.

The good news is we are getting closer to receiving the data.

I am looking forward to reviewing the final result.

Good luck,
Farrell

Thanks for posting. This article is very important.

This study and its sister study showed none of the drugs studied, Remdesivir,lopinavir/ritonavir, lopinavir/ritonavir–IFN–ß-1a [–IFN–ß-1a is an interferon} and hydroxychloroquine had a significant benefit against moderate to severe Covid19.

https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00485-0/fulltext#coronavirus-linkback-header

https://www.clinicalmicrobiologyandinfection.com/article/S1198-743X(21)00259-7/fulltext

At this point over 18 months after the beginning of the Covid 19 epidemic we do not have a proven antiviral for patients with moderate to severe Covid 19.

In addition vaccinations have shown their limitations. While it is clear vaccines limit severe illness and death , it is also clear the break through infections mean the vaccinated can not only become sick and die ,but can further spread Covid. The goal of having herd immunity from vaccines is now more difficult to obtain.

Plus the CDC is being criticized for not making the complications of Covid and the vaccines available to the public or others in the health care system.Many suggest looking to England and Israel for more insight into the delta variant surge and vaccinations.

https://www.washingtonpost.com/health/2021/08/18/cdc-data-delay-delta-variant/

https://www.cnbc.com/2021/08/12/herd-immunity-is-mythical-with-the-covid-delta-variant-experts-say.html

It is not surprising the government is focusing on antiviral research.

https://www.hhs.gov/about/news/2021/06/17/biden-administration-invest-3-billion-american-rescue-plan-as-part-covid-19-antiviral-development-strategy.html

Hopefully Brilacidin's phase 2 study will show it is effective against Covid 19.

GLTA,

Farrell

At that point IPIX is on to Ulcerative Colitis which I am very excited about. The phase 2 study of Brilacidin for Ulcerative Proctitis was fantastic even though the number of patients was small.

The Oral Mucosiditis phase 3 study is planned for 2022.
"Additional work tied to starting, in 2022, a planned Phase 3 study of Brilacidin in Oral Mucositis is also in progress. We aim to maintain momentum across our clinical programs.”

IPIX has announced the stage 2 Ulcerative Colitis oral Brilacidin study should start in the next few months:

"Development work related to the formulation and manufacture of Brilacidin in capsule form is underway to support our Phase 2 trial in Ulcerative Colitis planned to commence this year."

In addition Alfasigma is making plans to study Brilacidin for Ulcerative Proctitis:

"Also in the pipeline, Alfasigma S.p.A. (“Alfasigma”)—the licensee of worldwide rights to develop, manufacture and commercialize rectally-administered Brilacidin for treatment of Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS)—notified the Company, in April, of its intentions to commence, in 2021, a Phase 2 multinational clinical trial of Brilacidin for UP/UPS. Alfasigma has placed an order with the Company for Brilacidin drug substance needed for the trial, which the Company is in the process of supplying. Per the licensing agreement, Innovation Pharma is eligible to receive $24 million in upfront and milestone p2022ayments, and a 6 percent royalty (net sales), upon the successful marketing of Brilacidin for UP/UPS."

http://www.ipharminc.com/press-release/2021/5/13/innovation-pharma-files-form-10-q-patient-enrollment-in-phase-2-clinical-trial-of-brilacidin-for-covid-19-tops-70-percent

GLTA Farrell

Synergy between Remdesivir and Brilacidin was predicted in the antiviral in vitro studies. Phase 2 confirmation of the synergy would be terrific.


Unfortunately it is likely only a few patients treated in the US received Remdesivir. The SOC antiviral in Russia is most likely Favipiravir.

Hopefully Brilacidin's anti-inflammatory effects will reduce pulmonary and other complications in the patients who are more ill.

We will see when the full results are reported.

GLTA Farrell

The point of the trial is to see if Brilacidin + SOC is superior to SOC alone.

We should know the result very soon.

Glta,
Farrell

Do you really believe your statement?

"Where’s the “independent testing”? The only “independent” thing I see is that a lab technician at GMU (probably a student) did the bench work. IPIX was involved in the rest."

George Mason is one of the 12 facilities in the country which has a BSL research lab. They do viral research for a variety of indications for government, private and corporate entities. They are one of the few BSL labs with a background in doing research on defensins and human defense proteins.

https://cidr.science.gmu.edu/

The following description reflects the sophistication of research performed at George Mason BSL

https://www.niaid.nih.gov/research/george-mason-regional-biocontainment-lab

https://cidr.science.gmu.edu/research-and-facilities/research-services/

If you have concerns about George Mason's integrity you should contact the university or the NIAID.

GLTA Farrell

Scored some at .227 ;more stink bids are in place.

All I can say is thank you so much to the individuals that are selling.

Data lock soon???

GLTA, Farrell

More proof therapeutics needed for corona virus infection #2

Washington understands vaccines are not protecting the public or providing herd immunity as hoped. Their political futures require action to halt the pandemic.

Washington announces a new plan to fight viral pandemics. Biden will present the American Pandemic Preparedness Plan tomorrow night.


https://www.whitehouse.gov/wp-content/uploads/2021/09/American-Pandemic-Preparedness-Transforming-Our-Capabilities-Final-For-Web.pdf

GLTA Farrell

From the presentation. Therapeutics highlights:


2. Therapeutics

Goal: Have a range of therapeutics suitable for any virus family, available before a pandemic
or readily created during a pandemic.

(2.1) Inhibiting key viral functions. Develop inhibitors that target essential viral functions, such as cell
entry and replication, for any human viruses within a family or subfamily. (Effective inhibitors of this
type have been developed for HIV and Hepatitis C.) Viral inhibitors would be valuable for treatment and
prevention in both pandemic response and ordinary times (for example, to treat shingles or virally-
caused meningitis). Promising approaches to develop anti-viral therapeutics include: (i) broadly-acting,
small-molecule therapeutics against key viral functions, in advance of a pandemic and (ii) programmable
RNA-based therapeutics targeted against specific viruses, for use during a pandemic.

Funding

2. Therapeutics $11.8
2.1 Develop antivirals that inhibit key proteins for viral families, and evaluate in clinical
trials against relevant diseases

2.3 Develop host-specific therapeutics and immunomodulators, and evaluate in clinical


2.1) Inhibiting key viral functions. Develop inhibitors that target essential viral functions, such as cell
entry and replication, for any human viruses within a family or subfamily. (Effective inhibitors of this
type have been developed for HIV and Hepatitis C.) Viral inhibitors would be valuable for treatment and
prevention in both pandemic response and ordinary times (for example, to treat shingles or virally-
caused meningitis). Promising approaches to develop anti-viral therapeutics include:
• Develop broadly-acting small-molecule therapeutics against key viral functions, in advance of
a pandemic. Development of small-molecule therapeutics against viral proteins, such as
polymerases or proteases, is a well-established approach — involving high-throughput screening
using in vitro or cellular systems to identify molecules, chemical optimization to produce lead
molecules, preclinical testing, and clinical testing. Because the approach is too slow to enable
creation of new therapeutics in the midst of a pandemic, it is necessary to identify and test
broadly-acting therapeutics against viral families in advance of a pandemic. The goal would be to
develop therapeutics that are effective across a broad spectrum of viruses within a viral family
or across multiple viral families.


2.3) Controlling counterproductive patient responses to infection. Develop and characterize new
therapeutics that limit damage from infectious diseases caused by over-or under-active responses of the
human body to infection.
• Develop therapeutics to modulate responses by the immune, circulatory, and other organ
systems to viral infection. Modulators of the immune system—such as dexamethasone and
tocilizumab, which act through distinct mechanisms—were found to reduce mortality among
the sickest COVID-19 patients. Therapeutics targeting the respiratory system or the circulatory
system would be useful for treatment of pneumonia or blood clotting symptoms in both
ordinary times and during pandemic response.

More proof therapeutics needed for corona virus infection

Up to date delta corona virus cases in England.

Vaccinations: up to 89% for 1 80% for 2

Deaths: at a 4 month high 191 per day

Hospitalizations: at a 4 month high 933 per day

See Graphs at:

https://coronavirus.data.gov.uk/

UK summary

The official UK government website for data and insights on coronavirus (COVID-19).

See the simple summary for the UK.
Vaccinations
People vaccinated

Up to and including 7 September 2021

Percentage of population aged 16+
88.9%
1st dose
80.3%
2nd dose

People tested positive

Latest data provided on 8 September 2021
Daily
38,975
Last 7 days
272,475
arrow 36,196 (15.3%)
Rate per 100,000 people: 377.4
Graph - click for more details

All cases data
Deaths
Deaths within 28 days of positive test

Latest data provided on 8 September 2021
Daily
191
Last 7 days
932
arrow 193 (26.1%)
Rate per 100,000 people: 1.2


All deaths data
Healthcare
Patients admitted

Latest data provided on 4 September 2021
Daily
933
Last 7 days
6,730
arrow 205 (3.1%)
Graph - click for more details

Could you supply a link for your assertion that Covid vaccines are associated with ADE?

GLTA Farrell

I could not find the 226 billion documented ,but I did find this program announced a few months ago:

https://ncats.nih.gov/antivirals

Interesting some of the viruses of interest named were the ones reported in the recent GMU research of Brilacidin's antiviral effects.

In addition to SARS-CoV-2, NCATS’ activities will address other viruses within the scope of the APP that represent known threats because of their pandemic potential. The table below shows virus families/orders and examples of viruses that the APP may target.


Viral Family/Order Example Viruses
Coronaviridae SARS-CoV, MERS-CoV, SARS-CoV-2
Bunyavirales Rift Valley fever, Hantavirus, Crimean-Congo hemorrhagic fever
Filoviridae Ebola, Marburg
Flaviviridae Yellow fever, Dengue, Zika
Paramyxoviridae Hendra, Nipah
Picornaviridae Enterovirus D68
Togaviridae Chikungunya

From post 366725

Bunyavirus infections are the causative agent in a number of serious human diseases.

Pneumonitis
-Hantavirus has a mortality rate of 35%
https://www.ecdc.europa.eu/en/hantavirus-infection/facts
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3840873/

Hemorrhagic fever
-Rift valley fever
https://www.cdc.gov/vhf/rvf/about.html
-Lassa fever
https://www.who.int/health-topics/lassa-fever#tab=tab_1
Severe fever with thrombocytopenia syndrome (SFTS}
https://www.nature.com/articles/s12276-021-00610-1

Encephalitis
-California and LaCross encephalitis
https://emedicine.medscape.com/article/234159-overview
-Crimea-congo encephalitis
https://www.who.int/news-room/fact-sheets/detail/crimean-congo-haemorrhagic-fever

Brilacidin is also reported to be effective in some alpha viruses.

Alpha viral diseases include Togaviridae. Virus, chickungunya; Ross River; Mayaro; , O'nyong-nyong; Sindbis; eastern equine encephalitis; Venezuelan equine encephalitis.

GLTA Farrell

Assuming the phase 2 study of Brilacidin confirms its safety and efficacy against Covid 19 and an EUA is released at the interim report of the phase 3 study or before my guess is the timing would be similar to Regeneron's experience which was about 9 mos between its EUA for treatment of mild disease and approval for prophylaxsis.You can add as many months as you think it will take to obtain an EUA to the 9 mos.


I would expect it to be studied for prophylaxsis in high risk adults on exposure, after a positive covid test and at the onset of symptoms.


Regeneron's EUA for treatment of mild covid was approved on
11/21/2020. Its approval for prophylaxsis was on 7/30/2021.

GLTA, Farrell

https://www.healio.com/news/infectious-disease/20210730/fda-authorizes-regeneron-antibody-cocktail-for-postexposure-prophylaxis-of-covid19

https://www.healio.com/news/infectious-disease/20210804/regeneron-cocktail-shows-promise-as-postexposure-prophylaxis-for-covid19

Latest CDC projections of delta variant surge plus graphs.

This week’s national ensemble predicts that the number of newly reported COVID-19 deaths will likely increase over the next 4 weeks, with 5,100 to 17,700 new deaths likely reported in the week ending September 18,

https://www.cdc.gov/coronavirus/2019-ncov/science/forecasting/forecasting-us.html

GLTA Farrell

All the earlier studies show it is not absorbed orally. It is possible to formulate some IV or IM meds into oral medications or IM depo injections If the phase 2 or 3 leads to and EUA I would like for them to begin that research.

Below is an article describing how peptides formulated for diabetes were converted to an oral form.

https://cen.acs.org/pharmaceuticals/biologics/oral-form-blockbuster-diabetes-drug-has-arrived/97/web/2019/12

GLTA,Farrell

The company,Innovation Pharmaceuticals, has expressed an interest in making an inhaler for pulmonary diseases which would likely include Covid. Hopefully, the inhaler for Covid could be given prophetically either at exposure or the on the beginning of symptoms.

GLTA, Farrell

The government needs to redouble its efforts to fund therapeutic research. More and more of the leading experts have expressed an opinion that herd immunity is not possible with current vaccines.
And, many predicted increasingly resistant, dangerous variants.

GLTA, Farrell