You are ignoring the fact
every covid antiviral was studied on the hospitalized moderate to severe patients first. Do your homework.

Glta, Farrell

I believe the government, FDA,and NIH are now and have been desperate for an antiviral effective against Covid . The biggest need is for hospitalized patients with severe pulmonary failure. The death rate with mechanically ventilated Covid patients is between 80% to 90%.

At the time IPIX had their meeting with the FDA the Covid infection, hospitalization and death rate were escalating.

It would be in any drug company's financial interest to begin their Covid drug studies on patients with the highest chance for
success, patients with mild disease, but in this setting that was not possible for Brilacidin or any covid therapeutic.

I have no direct information on IPIX's meeting with FDA, but I do understand the tremendous political and humanitarian pressure to help the covid patients who were the sickest with the highest death rate. I also know virtually every antiviral drug's initial clinical trial was on the moderate to severely ill hospitalized covid patients.It is clear to me the only possible option the FDA gave IPIX was to study Brilacidin on the moderate to severe hospitalized covid patient

Even though the Covid infection rate is now falling, the death rate has remained surprisingly high. The NIH,FDA and the government are still desperate to find better treatments for Covid. The government seems interested in studying therapeutics in its fully funded ACTIV trials. Now the Biden administration is funding a 3 billion dollar program for Covid and antiviral treatments.

https://www.niaid.nih.gov/news-events/biden-administration-invest-3-billion-american-rescue-plan-part-covid-19-antiviral

https://www.nih.gov/research-training/medical-research-initiatives/activ/covid-19-therapeutics-prioritized-testing-clinical-trial

I believe the latest PR will lead to Brilacidin being funded for another covid trial as outlined by Mr Ehrlich:

"Given the need for development of new small molecule antivirals and immunomodulators, the Company is planning to submit Brilacidin for possible inclusion in government-sponsored COVID-19 trial platforms, e.g., the NIH ACTIV program. Platform trials, which typically enroll hundreds of patients per treatment arm, can more accurately evaluate the treatment potential of COVID-19 drug candidates. Pursing a biomarker-driven approach, increasing Brilacidin dosing and treatment duration, targeting different patient populations, testing Brilacidin in combination with drugs exhibiting different mechanisms of action (e.g., remdesivir, given strong synergistic in vitro data)—all are possible elements of any future Brilacidin COVID-19 trial design. Compassionate use of Brilacidin also is anticipated to continue, which could further inform Brilacidin’s treatment effects in COVID-19. For more details on the Company’s Compassionate Use policy, please visit:
https://www.ipharminc.com/expanded-access-and-compassionate-use

The Company also plans to seek additional clinical development support from the NIH Antiviral Program for Pandemics (APP). Brilacidin for prophylactic use, including assessing Brilacidin in pre-clinical animal models, is of particular interest due to Brilacidin’s blocking and neutralizing antiviral properties and industry investment in developing intranasal-targeted, direct-acting antivirals. Preliminary Brilacidin formulation work for inhaled delivery has been conducted, with the NIH APP a potential avenue to expand on this work, along with exploring the subcutaneous administration of Brilacidin, which has greater than 70 percent bioavailability via this route of administration."

GLTA,Farrell... all in my opinion

Its hard to respond to a post so poorly written.

If you could review your post and clearly state what your point is, I will make an appropriate response.

GLTA Farrell

It is all in the PR for those who care to read it:

https://www.ipharminc.com/press-release/2022/3/7/innovation-pharmaceuticals-reports-additional-findings-based-on-review-of-brilacidin-phase-2-covid-19-trial-results-and-compassionate-use-cases

“These results, along with observations on the compassionate use of Brilacidin in COVID-19 related to dosing, as well as data being generated from ongoing scientific collaborations, are informing paths forward for our Brilacidin antiviral program. We believe Brilacidin has merit to help address COVID-19 and can play a role in preparing for future pandemics, given Brilacidin’s unique immunomodulatory and antiviral properties. Progress in the Brilacidin antiviral program largely will be dependent upon obtaining government funding for additional clinical development and leveraging external research relationships. "

Glta,

Farrell

JMO I am very optimistic IPIX will receive government funding.

As per the PR, Mr Ehrlich is working to accomplish that goal.

Glta, Farrell

If Remdesivir can have disappointing results in its clinical trial and still be the Covid drug of choice for Covid for many months, why should IPIX not further study Brilacidin for other indications?


After all all the antivirals, convalescent serum, monoclonal antibodies and other drugs studied as antivirals for moderate to severe Covid in hospitalized patients failed their trials. Many of those drugs were shown to be effective in other indications such as prophylaxis in high risk patients and mild Covid.

I am encouraged IPIX is studying Brilacidin inhalers and subcutaneous injections for use as other treatment modalities.

IMO Brilacidin should be studied for use in the subgroups where efficacy has been suggested in the statistical review of the phase 2 study.

If Brilacidin may prevent a certain percentage of the hospitalized Covid patients from progressing, it would be criminal not to fully study it.

GLTA, Farrell

Thanks for posting. Of course Anthrax is not a virus, but a bacteria ,bacillus anthracis, which has the potential to be a bioweapon.

https://www.cdc.gov/anthrax/bioterrorism/threat.html

It is easy to see why the Department of defense would be interested in aa potent antiviral and antibiotic such as Brilacidin.

Good luck to all,

Farrell

You have to admit it is a much better way to handle the trial data than the Remdesivir trial where the FDA and Gilead changed end points in mid trial

Plus Remdesivir has been used to treat millions with covid.

https://www.statnews.com/2020/05/05/were-researchers-wrong-to-move-the-goalposts-on-remdesivir-in-the-end-it-may-not-have-mattered/

Good luck, Farrell

My take is the results are good enough for future government funding of an additional stage 2-3 NIH trials. The results suggest Brilacidin at higher doses and longer duration may provide additional benefit,both as an antiviral and anti inflammatory.

In addition Brilacidn for prophylaxis and in less ill patients befire hospitalization may prove beneficial.

Compare Brilacidin's results to the therapeutics studied in the ACTIV trials and I think most will agree Brilacidin deserves similar study.

https://www.nih.gov/research-training/medical-research-initiatives/activ/covid-19-therapeutics-prioritized-testing-clinical-trials

GLTA Farrell

Thanks for posting the reminder about the ADE concern.

GLTA,Farrell

Generally the US health statistics are less reliable because all 50 states collect data and report it in different ways. Most of the data comes from county health departments which vary greatly in reliability. It is even worse for covid because the outbreaks are regional and spread over weeks which distorts the reporting.

The article I posted reflects the confusion in making public health decisions from US data. It also shows the difficulty in making personal health decisions based on the very incomplete data and inconsistent advice given by the CDC.

A good example is the recent CDC advice which allows healthcare workers who have contracted covid to return to work immediately in a crisis situation at their health care institution.

Unfortunately health care staffing is frequently at a crisis level which means the nurse doctor or staff person taking care of you or your family could have active,contagious Covid.

https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-risk-assesment-hcp.html

The best covid statistics in my experience are from Israel and the United Kingdom.

GLTA, Farrell

Mysteries of Covid vaccinations: Why are so many Americans still dying of Covid

https://nymag.com/intelligencer/2022/02/why-are-so-many-americans-still-dying-of-covid.html?utm_source=pocket-newtab

"Why are so many Americans still dying of COVID? The seven-day average is now 2,500 a day, higher than at any point in the last two years outside last January — before vaccines, at the height of the most devastating phase of the pandemic. Yesterday, the total reported dead was 3,600."

A good review of confusing vaccine statistics is presented. The review does present various possibilities of why so many are dying in spite of increasing numbers of Americans being vaccinated,but no real answer yet.

Just my opinion: While no doubt exists being vaccinated does reduce the rate of hospitalizations and death; the vaccines do not work well enough even in the face of a less pathologic covid variant,Omicron, to reduce a frighteningly high death rate.

Just don't tell me therapeutics are not needed.

GLTA Farrell

"Only effective ones who haven't failed an FDA trial."

But, that's the problem isn't it.

All of the antivirals for hospitalized Covid patients with moderate to severe covid have failed.

OK, except for Remedesivir which was shown to shorten hospital length of stay. And, it achieved its primary end point ...after the primary end point was changed in the middle of the trial.

How did the makers of Remdesivir, Regeneron's anti covid antiviral, Molnupiravir,ritonavir respond to failing their initial trial against covid?

Did the other companies stop their studies. No they changed to study their drugs at earlier states of covid infection...for viral prophylaxis and mild infection.

You are right that anyone dying from Covid-19 is a tragedy. Covid patients need better treatments.

GLTA,Farrell

NIH combo trials?...

During the Ebola outbreaks, HIV epidemic and hepatitis c when vaccines and single antivirals either did not work, worked poorly, or were not practical studies were shifted to combination trials of antivirals.

Examples of combination antivirals :
1.Zmapp a combination of 3 monoclonal antibodies for Ebola,
2.Triple antivirals for AIDS
3.Hepatitis c where sofosbuvir and ribavirin may be used in combination

The combination antivirals produced life saving treatments for deadly diseases.

The combinations often are changed and optimized with time as new drugs are developed.

Why has the NIH and FDA been slow to promote more combination antivirals against Covid?

That is a good question.

I can not think of a good reason why combination antiviral studies for Covid have not been a priority.

GLTA, Farrell

While vaccination lowers the risk of death and hospitalization, it may not lower the risk of catching Covid and it does not eliminate the risk of dying from Covid, even in the triple vaccinated.

Therapeutics are still needed.

Israel a country where Covid vaccination is almost universal. Below are reports from January 2022.

"The Health Ministry updated its coronavirus figures on Friday, revealing that nearly 70,000 Israelis tested positive for COVID-19 the day before, with the number of patients in serious condition climbing to 638.

Total active cases rose to 427,023 and 1,758 Israelis were hospitalized in all, with 123 of them on ventilators.

At least 9,867 medical staff were sidelined after contracting COVID themselves, including 1,379 doctors and 2,916 nurses, the ministry said."

https://www.timesofisrael.com/israel-sees-70000-new-covid-cases-with-638-hospitalized-in-serious-condition/

"On Wednesday, the Israeli government reported that a record 11,978 new infections were registered the day before. That beats the previous high of 11,345 infections in a single day set Sept. 2 during the Delta variant wave."

"Israel also is on the cusp of making available drugs that could help people in at-risk groups avoid severe infections."

"There is no control of the Omicron wave,” Sharon Alroy-Preis, the Israeli Health Ministry’s top public health official, said on Israel’s Channel 13 this week."

"The Health Ministry updated its coronavirus figures on Friday, revealing that nearly 70,000 Israelis tested positive for COVID-19 the day before, with the number of patients in serious condition climbing to 638.

Total active cases rose to 427,023 and 1,758 Israelis were hospitalized in all, with 123 of them on ventilators.

At least 9,867 medical staff were sidelined after contracting COVID themselves, including 1,379 doctors and 2,916 nurses, the ministry said."

https://www.latimes.com/world-nation/story/2022-01-05/israel-all-time-high-covid-infections-fourth-vaccine


Since the vaccines do not eliminate deaths or hospitalization, what will we do for the next variant which may be more deadly than Omicron. Are we going to give a 4th vaccine like the Israelis? Will it make sense to give the 5th, 6th or 7th vaccine booster?

IMO this is the time to develop therapeutics.

GLTA, Farrell

King, this is the 8K from 9/2021. By my reading it says ERHC has 100% interest in EEZ blocl 4 and the other party has withdrawn its claim.

Can you repost your evidence?

GLTA,

Farrell


"An arbitration holding in London, England, under the auspices of the International Chamber of Commerce, between a foreign multinational and ERHC Energy Inc. (together the “Parties”) has been concluded by the withdrawal of further claims and the entry of a final award (“Final Award”) by the sole arbitrator.

2.
The arbitration concerned an assignment agreement (“Agreement”) and a deed of assignment (“Deed”) entered into on October 17, 2017, between the Parties.

3.
The sole arbitrator had on August 15, 2018, rendered a partial award (“Partial Award”) which held that as of the date of the Agreement and Deed, ERHC Energy Inc. is and was the legal and beneficial owner of a 100% working interest in Block 4 of the Exclusive Economic Zone, offshore Sao Tome and Principe. The Partial Award also upheld the foreign multinational’s rights and interests by virtue of the Agreement and Deed as valid and enforceable.

4.
The Partial Award was upheld by, and constituted into, the judgment of the High Court of Justice of England and Wales on January 4, 2019.

5.
The Final Award, which has just been delivered in 2021, upheld the withdrawal of all other claims in the matter, made orders as to the sharing of costs between the Parties and ends the matter with finality. "

End of phase 2 meeting from ProPharma Group:

IMO application to an ACTIV trial would require a end of phase 2 meeting with the FDA.


End of Phase 2 (EOP2) Meetings
What is the Purpose of the End of Phase 2 Meeting with the FDA

Following your Phase 2 clinical trials, you will need to review and obtain agreement from the FDA on your study designs for Phase 3. This is the purpose of the End of Phase 2 (EOP2) Meeting with FDA, in which you’ll need to effectively present your Phase 3 and submission strategy and ensure that you are aligned with the FDA prior to the start of Phase 3.

During this meeting, FDA will determine whether it’s safe to proceed to Phase 3. They will evaluate your Phase 3 plans and protocols along with your existing studies to assess effectiveness, and they’ll note if any additional information is necessary to support the marketing application. The End of Phase 2 Meeting is a critical milestone in your development program, so it’s important to prepare in order to make sure you leave with plenty of helpful feedback.
Who is Eligible for an End of Phase 2 Meeting?

The EOP2 Meeting with the FDA is typically for Investigational New Drugs (INDs) which involve new molecular entities or major new uses of marketed drugs. However, a Sponsor of any IND may request an EOP2 Meeting with FDA in preparation for Phase 3.
When Should the End of Phase 2 Meeting occur?

As the name implies, the EOP2 Meeting should occur at the end of Phase 2 clinical trials. Furthermore, the meeting should occur before serious resource commitments are made towards Phase 3. However, the EOP2 Meeting should not delay the transition from Phase 2 to Phase 3, which is why planning and preparation are critical.
Preparation for End of Phase 2 Meeting

To move you to the next clinical trial phase, ProPharma Group will diligently work with you to prepare for the EOP2 Meeting. With your input, our experts will:

Develop the EOP2 briefing package to be sent to FDA in advance of the meeting
Request the EOP2 Meeting
Determine meeting objectives and agenda and script the participants
Conduct a meeting rehearsal at our offices in Washington, DC
Attend the meeting with you and summarize results in formal notes
Conduct a debriefing session to discuss the accomplishment of meeting objectives and finalize meeting minutes to be sent to the FDA


https://www.propharmagroup.com/regulatory-affairs/end-of-phase-2-eop2-meetings/

https://www.lawinsider.com/dictionary/end-of-phase-2-meeting

GLTA,

Farrell

At this point the final review of the phase 2 study of Brilacidin for Covid has not been announced.

IPIX has stated entering the fully funded NIH ACTIV trials as a goal for Brilacidin.

As you know the next step for IPIX is planning its end of Phase 2 meeting with the FDA. IPIX has stated it will also review analysis of the compassionate use data which has not been released in addition to the final analysis of the Phase 2 data.

"The Innovation team is working with biostatistics partners to explore the data—conducting deeper analysis of different subgroups by patient demographics and baseline characteristics, domestic versus overseas COVID-19 standards of care, and more—to potentially identify meaningful patterns and positive trends. Analysis of the compassionate use of Brilacidin in the U.S. in critically-ill COVID-19 patients who had exhausted all other therapeutic options also is planned. Changes to biomarkers and positive clinical changes were observed, with some compassionate use patients administered Brilacidin more frequently and over a longer duration than patients in the Phase 2 Brilacidin COVID-19 trial. Collectively, these actions will help inform next steps for Brilacidin against COVID-19 in the coming year"

Law insider defines the end of phase 2 FDA meeting as follows:

"End of Phase 2 Meeting means a meeting with FDA, the purpose of which is to determine the safety of initiating a first Phase III Clinical Study, to evaluate the Phase III Clinical Study plan and protocols and the adequacy of current studies and plans to assess pediatric safety and effectiveness, and to identify any additional information necessary to support a Drug Approval Application for the uses under investigation, as further defined in 21 C.F.R. 312.47(b)(1), as amended from time to time..."

The phase 2 interim safety data was satisfactory in the Phase 2 study for Brilacidin for Covid which allowed the dosing to be increased to 5 days.



The answers to your questions are all here:

http://www.ipharminc.com/press-release/2021/12/7/innovation-pharmaceuticals-analyzing-full-dataset-for-its-brilacidin-covid-19-clinical-trial-company-evaluating-new-pipeline-opportunities-for-2022

http://www.ipharminc.com/press-release/2021/11/18/innovation-pharmaceuticals-provides-brilacidin-program-update

http://www.ipharminc.com/new-blog/2022/1/25/shareholder-alert-upcoming-update-on-brilacidin-in-covid-19

GLTA,Farrell

Here the list of all the medications in the Activ trials to date.

https://www.nih.gov/activ/nih-funded-activ/activ-associated-clinical-trial.

As you can see it includes repurposed drugs like Aspirin and Ivermectin as well as the latest monoclonal antibodies. Most of the drugs are anti-inflammatories. A few are antivirals.

When you review the list, it is not impressive.It is surprising how few drugs are left to be tested against Covid. These drugs are a last ditch effort by the NIH to find any drug with any degree of efficacy against Covid.

Let me know if you find one with where government sponsored in vitro testing against Covid produced a selectivity index of 426.

I believe IPIX, as it has stated publicly, is actively pursuing inclusion in the ACTIV trials. I believe it is important to pursue the Activ testing of Brilacidin against Covid by itself and in combination with different drugs at different stages of Covid. Of course the NIH will make the decision

GLTA,

Farrell

11/12/2021 PR

"Complete analysis of trial results already has begun, with the aim to potentially identify positive trends in the data that could support Brilacidin for inclusion in larger COVID-19 platform trials, such as the U.K.’s CTAP program and the NIH’s ACTIV program. The purpose of these programs is to prioritize development of promising COVID-19 therapeutics."

12/7/2021 PR

"The Company is pleased to report that as of last week it had received all unblinded data/data outputs from the recently completed Phase 2 clinical trial of Brilacidin for treatment of moderate-to-severe COVID-19 in hospitalized patients. The Innovation team is working with biostatistics partners to explore the data—conducting deeper analysis of different subgroups by patient demographics and baseline characteristics, domestic versus overseas COVID-19 standards of care, and more—to potentially identify meaningful patterns and positive trends. Analysis of the compassionate use of Brilacidin in the U.S. in critically-ill COVID-19 patients who had exhausted all other therapeutic options also is planned. Changes to biomarkers and positive clinical changes were observed, with some compassionate use patients administered Brilacidin more frequently and over a longer duration than patients in the Phase 2 Brilacidin COVID-19 trial. Collectively, these actions will help inform next steps for Brilacidin against COVID-19 in the coming year, while Brilacidin’s broad-spectrum antiviral properties continue to be researched through NIH and other scientific collaborations."

1/25/2022

"Upcoming Update on Brilacidin in COVID-19"

"Collaborative work with NIH and other researchers on Brilacidin’s broad-spectrum antiviral properties is ongoing and generating promising data, with future updates planned."

A common thread it the 2 PR's and the share holders letter are Brilacidin and the NIH

Could the promise of an update on Brilacidin in Covid 19 be in regards to the inclusion of Brilacidin in the NIH's fully funded ACTIV trial for Covid19 therapeutics?

You have to decide for yourself.

If Brilacidin is to be included in the fully funded ACTIV therapeutics trial IPIX's share price is much too low.

Stay tuned.

JMO

GLTA,

Farrell

Thanks for reposting the link to the abstract.

Farrell

Anyone have a medical military clearance for the 2021 MHRSR?

The abstract from the 2021 MHRSR may have been posted, but it takes a military password to access.

https://mhsrs.amedd.army.mil/SitePages/Home.aspx

Glta,

Farrell

24 trades so far; 20,000,000 at 11:07; last trade 1,000,000.

Looks like multiple buyers are nibbling.

Why today?

GLTA, Farrell

Here is the flip side of that perspective. The bottom line is no one knows how this will turn out.

"An immunologist says a fully vaccine-resistant variant is ‘inevitable"

https://fortune.com/2021/12/21/immunologist-mark-dybul-omicron-vaccine-resistant-covid-variant/

GLTA,Farrell

Many people feel that will be the case. Others think as long as the virus continues to mutate around the world it will continue to be a public health nightmare.

We will see how it turns out.

Glta,
Farrell

We will see what happens with Omicron; we are just in the first inning. Even though the death rate is lower it spreads quickly. There is evidence previous vaccinations and infection are not protective.Plus many communities still have many delta hospitalizations.

It is possibile with so many more people becoming infected the hospitals could become overburden which will shut down the economy again. That is, even though a smaller percentage become hospitalized with so many becoming infected the absolute number with severe illness could be quite high.

Then, the possibility exists the next mutation will be much worse.

Sir Andrew Pollard at the English Oxford vaccination group has also been skeptical of universal vaccination for healthy young individuals.

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

GLTA, Farrell

At this point none of the other antiviral drugs have shown effectiveness in patients with moderate to severe Covid 19 eg Remdesivir, Regeneron's covid antibiotic,Ritonavir Molnupiravir,, or convalescent serum.

IPIX is reported to be its reviewing the Phase 2 trial data as well as the compassionate use data. We should know the results of this review soon. Even if the review shows no benefit in hospitalized patients with moderate to severe Covid it does not mean Brilacidin will not be an effective treatment for Covid19.

Did the other companies give up when they failed in their trials for hospitalized patients with moderate to severe Covid?

No, they tried to find their niche in the treatment of Covid. Do the other drugs have better in vitro results or a better safety profile than Brilacidin. In my opinion they do not. How many have potential Covid 19 antiviral drugs have a Selectivity index better than 146?

Omicron's rapid spread and multiple mutations represents a serious progression in the Coronavirus pandemic. Even though Omicron is reported to be less deadly, its high rate of contagion, even in the triple vaccinated, has the potential to have severe effects on the economy and society at large.

Unless you live in a bunker you should be scared of the Cornavirus pandemic, including current and future mutations.

We should all pray the research being done on therapeutics produces effective treatments.

The NIH is obviously concerned about the continuing Corona virus pandemic. It has dedicated substantial funding to therapeutic research including the ACTIV trials.

IPIX has mentioned the ACTIV trial as a future goal for Brilacidin research which is looking for repurposed drugs with anticovid activity.

The ACTIV trial currently is studying drugs including Ivermectin, Fluvoxamine and Fluticasone at 49 locations.

"Complete analysis of trial results already has begun, with the aim to potentially identify positive trends in the data that could support Brilacidin for inclusion in larger COVID-19 platform trials, such as the U.K.’s CTAP program and the NIH’s ACTIV program. The purpose of these programs is to prioritize development of promising COVID-19 therapeutics"

Of course other possibilities for advancement of Brilacidin for Covid 19 exist. Further review of the Phase 2 study and compassionate use may result in the FDA approving a phase 3 study; especially in the setting of persistent Covid infections, the shortcomings of vaccinations, and the development of future mutations.

Another possibility is a clinical trial combining Remdesivir and Brilacidin to take advantage of their synergistic antiviral effects.

IMO the current situation with the development of Omicron, the certainty of future mutations and their effects on the economy, geopolitics, education, childhood development and many other aspects of our society, the chance of Brilacidin's inclusion in the ACTIV trial is much higher today.

GLTA, Farrell

Pardon the inclusion of parts of previous posts in this post



.

Everyone is not that optimistic:

"The SARS-Cov-2 is only a mutation or 2 from away from being completely resistant..."

https://www.cuimc.columbia.edu/news/new-study-adds-more-evidence-omicron-immune-evasion

"The new study tested the ability of antibodies generated by vaccination to neutralize the omicron variant in laboratory assays that pitted antibodies against live viruses and against pseudoviruses constructed in the lab to mimic omicron.

Antibodies from people double-vaccinated with any of the four most widely used vaccines—Moderna, Pfizer, AstraZeneca, Johnson & Johnson—were significantly less effective at neutralizing the omicron variant compared to the ancestral virus. Antibodies from previously infected individuals were even less likely to neutralize omicron."

“The new results suggest that previously infected individuals and fully vaccinated individuals are at risk for infection with the omicron variant,” says Ho. “Even a third booster shot may not adequately protect against omicron infection, but of course it is advisable to get one, as you’ll still benefit from some immunity.”

"When administered early in the course of infection, monoclonal antibodies can prevent many individuals from developing severe COVID. But the new study suggests that all of the therapies currently in use and most in development are much less effective against omicron, if they work at all."

The need for antiviral therapeutics is increasing with each Covid mutation.

GLTA,Farrell

The Doomsday variant may be next,

https://www.newsweek.com/2021/08/13/doomsday-covid-variant-worse-delta-lambda-may-coming-scientists-say-1615874.html

Thanks for sharing.

GLTA,

Farrell

https://www.nbcnews.com/news/us-news/regeneron-says-covid-drug-less-effective-omicron-variant-rcna7039

Britain's NHS recently updated their Covid statistics.

https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/conditionsanddiseases/articles/coronaviruscovid19/latestinsights

Below is my interpretation of the English data.

What is apparent is that even though the Britain has achieved an over a 90% vaccination rate, Covid infection rates are now almost as high as the peak infection rate in Jan and Feb 2021. While the deaths and hospitalizations have declined they continue to persist at a relatively high level.

The data supports the reported shortcomings of the vaccines. The vaccines do not prevent reinfection and the vaccinated can spread Covid at an unfortunate rate. The vaccine lowers the rate of hospitalization and death , but the risk persists.

Double vacinnated individuals have a very low death rate.

The absolute deaths in the single vaccinated individual and unvaccinated are almost the same in October 2021.Of course, the rate of death is still higher in the unvaccinated.

Indivduals at risk need to be double vaccinated.

There is no significant decrease in protection in the double vaccinated with time which makes the rationale for boosters in the double vaccinated difficult to understand.

https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/conditionsanddiseases/articles/coronaviruscovid19latestinsights/deaths#deaths-by-vaccination-status

The death rate and hospitalization rate in young healthy individuals is very low. Since herd immunity is not possible and vaccinated individuals have a high rate of reinfection and transmission there is no rationale for vaccinating young healthy individuals.

https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/conditionsanddiseases/articles/coronaviruscovid19latestinsights/hospitals


If countries are going to mask and social distance the recommendations must be for both the vaccinated and unvaccinated

There is no evidence of herd immunity since the infection rate and vaccination rate are both high.

It is also obvious the world is at risk for future cornavirus mutations. Future variants are inevitable at this rate of infection and transmission.

The interpretation of the data is just my opinion.Read it yourself to come to your conclusions.

IMO the English public health data is the best in the world and their data most likely applies to most highly urbanized countries including the USA. The US data is collected by the local health departments and reported to the states; the variation in testing and collection standards of Covid data contributes to the confusion regarding Covid recommendations in the US.

JMO,

Farrell

Do you have a reference or link to confirm that statement?

"ERHC is currently in discussions with the Nigeria-Sao Tome & Principe Joint Development Authority (“JDA”) regarding the terms of a new Production Sharing Contract for Block 2 of the Joint Development Zone (“JDZ”). In addition to ERHC, the JDA has designated at least one new contractor on the PSC in replacement of interest-holders that have terminated their interests in the Block."

We know Sao Tome terminated Sinopec's rights to block 2.

Who is the new contractor?

BTW the price of natural gas has more than quadrupled in Europe this year.

https://ycharts.com/indicators/europe_natural_gas_price

GLTA, Farrell

I believe the ACTIV trials are just looking at individual drugs. The NIH has said they believe combinations of antivirals, eg like those used for HIV and Ebola will be the ultimate antiviral treatment for Covid.

Glta, Farrell

The PR shared some positive information about the phase 2 Brilacidin trial and the higher dose compassionate use

Will it be enough to qualify for the ACTIV trial? We will have to wait and see.

"Complete analysis of trial results already has begun, with the aim to potentially identify positive trends in the data that could support Brilacidin for inclusion in larger COVID-19 platform trials, such as the U.K.’s CTAP program and the NIH’s ACTIV program. The purpose of these programs is to prioritize development of promising COVID-19 therapeutics. Some COVID-19 drug candidates that did not meet their trial’s primary endpoint, for example Relief Therapeutics’ aviptadil, or those that showed inconclusive results in early clinical testing (e.g., anti-IL-6 drugs), have later gone on to be included in larger platform trials based on deeper analysis of trial results.

The Company’s intent, should full analysis of the Brilacidin COVID-19 trial results yield promising data, is to submit Brilacidin for inclusion in these larger COVID-19 platforms. Sufficient intravenous Brilacidin drug supply is on hand to support further clinical testing of Brilacidin in COVID-19."

https://www.ipharminc.com/press-release/2021/11/12/innovation-pharmaceuticals-conducting-full-data-analysis-of-phase-2-brilacidin-covid-19-trial-results-to-support-brilacidins-potential-inclusion-in-government-sponsored-covid-19-trials

GLTA,

Farrell

Interesting, 3 weeks ago Merck announced the US government agreed to buy over $2 billion dollars worth of Molunpirar.

"Nov 9 (Reuters) - The U.S. government will buy another $1 billion worth of the COVID-19 pill made by Merck & Co Inc (MRK.N) and partner Ridgeback Biotherapeutics, the companies said on Tuesday.

The government in June agreed to buy 1.7 million courses of molnupiravir for $1.2 billion and is now exercising options to buy 1.4 million more.

That brings the total secured courses to 3.1 million and worth $2.2 billion. Merck said the government has the right to buy 2 million more courses as part of the contract."

https://www.reuters.com/world/us/us-government-buy-14-mln-more-courses-mercks-covid-19-pill-2021-11-09/

"The variant is now tagged as B.1.1.529.

Over the past 48 hours, health officials spotted the new variant as it spurred an increase in infections around Johannesburg."

“This variant did surprise us — it has a big jump in evolution, many more mutations than we expected, especially after a very severe third wave of Delta,” said Tulio de Oliveira, director of the KwaZulu-Natal Research and Innovation Sequencing Platform, according to a report in The New York Times."

“The sequence of this variant, currently called B.1.1.529, was first uploaded by Hong Kong from a case of someone traveling from South Africa,” the British health minister, Sajid Javid, said. “The UK was the first country to identify the potential threat of this new variant and to alert international partners. Further cases have been identified in South Africa and in Botswana, and it is highly likely that it has now spread to other countries.”

https://endpts.com/new-coronavirus-mutation-takes-flight-around-the-globe-as-health-officials-scramble-to-mount-new-defenses/

Brilacidin's virucidal MOA against Coronavirus is unique. To the best of my knowledge Brilacidin is the only drug whose in vitro clinical studies demonstrate a virucidal action against covid 19.

Most other drugs just demonstrate 1 MOA. Brilaidin's 3 anti viral MOA: virucidal,prevention of viral entry and the possible effect against intracellular viral replications by inhibiting the viral m- Protein as shown in the computer modeling study suggest it is possible Brilacidin could lose 1 MOA and still be effective.

The conclusion of the Wang paper was that Brilaidin did block the coronavirus viral entry by 2 mechanism of action, viral and cellular.

GLTA,Farrell

The Wang paper and the Bakovic paper are not equivalent studies and should not be directly compared.

The Wang study was on 3 coronaviruses associated with the common cold as it outlines in the first paragraph.It also studied an HIV hybrid with a Sars2 spike protein. It did not study a cornavirus associated with Covid 19.

"Human coronavirus (HCoV)-229E, -NL63, -OC43 and -HKU1 account for 15~30% cases of common cold worldwide"

https://www.biorxiv.org/content/10.1101/2021.11.04.467344v1.full

The Wang paper did not study the chronaviruses associated with Covid 19 where the Bakovic paper studied viruses proven to cause Covid 19.

"SARS-CoV-2 (Washington strain 2019-nCoV/USA-WA1/2020) was obtained from BEI Resources (NR-52281) and was used for all infections..."

https://www.mdpi.com/1999-4915/13/2/271/htm

The Wang paper primarily studied the affect of Brilacidin on viral attachment and viral entry into the cell. It did not study the virucidal effects of Brilacidin as outlined in the Bakovic paper and as such the IC 50 in the Wang paper and the Bakovic paper should not be directly compared

The Wang paper is very important because it delineates how Brilacidin has 2 mechanisms of action in blocking viral entry to the cell by attaching to the host receptor as well as the virus.It also shows it binds to the heparin sulfate proteoglycans and not the spike protein like the monoclonal antibody treatments.

The covid 19 mutations described in the data to date affect the spike protein. Since Brilaidins activity is independent of spike protein mutation, it means Brilacidin is less likely to develop resistance to treatment.

The Bakovic study, both in Vero and human Calu-3 Cells, did assays which included both the virucidal MOA as well as blocking viral entry and discovered the low IC 50 and high Selectivity index. The Wang study of the virucidal effect is done in a way which would not be comparable.

The 2 studies should be looked on as being complementary rather than contradictory. Both studies confirm and further define the activity of Brilacidin against different species of cornavirus


The above is from my review of both studies. I am not a virologist and I look forward to informed comments.

GLTA,

Farrell

Brilacidin inhaler from 11/12/2021 PR

"Initial feasibility work to formulate Brilacidin for potential prophylactic use via inhaled delivery, to leverage Brilacidin’s unique virucidal and blocking antiviral properties, also is underway."

http://www.ipharminc.com/press-release/2021/11/12/innovation-pharmaceuticals-conducting-full-data-analysis-of-phase-2-brilacidin-covid-19-trial-results-to-support-brilacidins-potential-inclusion-in-government-sponsored-covid-19-trials

Contrary to recent criticism of your post, protein based inhaled drugs are currently approved therapeutics { eg insulin and many others} and more are being studied. See table 1. from the link below.

https://link.springer.com/article/10.1186/s43556-020-00014-z

239 peptide or protein based drugs are reported to be approved in this 2017 data base.

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0181748

The article is a good review of the promises and technical issues in formulating inhaled drugs.

Inhaled drugs are now commonly used. Many people with asthma and COPD use inhaled pharmaceuticals. Ask someone with severe asthma where their inhalers are and they frequently will pull them out of their pockets or purses.

http://www.ipharminc.com/press-release/2021/11/12/innovation-pharmaceuticals-conducting-full-data-analysis-of-phase-2-brilacidin-covid-19-trial-results-to-support-brilacidins-potential-inclusion-in-government-sponsored-covid-19-trials

Brilacidin will not be the first drug for covid where an inhaler was studied. Gilead has completed a clinical trial for remdesivir to be used as an inhaler.

https://clinicaltrials.gov/ct2/show/NCT04539262

Many inhaled drugs, including peptides and proteins, have been approved and many more are being studied. Given Brilacidin's potent antiviral in vitro studies as well as its safety it is more than reasonable to study Brilacidin as an inhaled therapeutic.

GLTA Farrell

Post of the day. Thanks for bringing some clarity to the issue of the prospective value of Brilacin. The value of Brilacidin will be based on what it is worth to the potential buyer{s}.

It will have little to do with how many shares IPIX has outstanding or that IPIX sold for 5 cents a few months ago or how much was paid in the past for products developed by small OTC companies.

The value of Brilacidin will depend very much on its ability to impact a pandemic which has cost trillions of dollars, infected tens of million of people and resulted in the deaths of over 5 million people.

It is simple if the phase 2 study of brilacidin for covid19 is strongly positive it will be virtually priceless; if it doesn't work for covid, IPIX will be seeking other uses for Brilacidin.

Remember an effective antiviral for moderate to severe covid does not currently exist.

Why would investors attempt to under estimate Brilacidin's value?

Thanks for the post,

Farrell

"Totally irrelevant in respect to an artificially depressed and very poorly managed asset from a capital and governance perspective.

If it turns out that there is gold here, it's worth gold, and the current price is effectively irrelevant in a bidding war to acquire said asset. Why sell yourself short on the outcome based on premium comps. If you think like this, we should all pray that you aren't Leo!"