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Thanks, the more eyes on Brilacidin the better.
Glta, Farrel
Gilead....as long as they are allowed to charge for both they will.
I agree with your point that Remdesivir has been over hyped and under delivers.
I think it will be rarely prescribed in a few months. Front line doctors are becoming skeptical of its efficacy.
If Brilacidin works as will in the clinic as it does in vitro it will be the number 1 prescribed antiviral for Covid19.
The bar for success if extemely low. Neither Remdesivir or Regeneron'a covid dual antibody have been able to report lower mortality rates or fewer long term complications.
"The impression of Remdesivir having lower efficacy is higher in the US vs internationally. Only 18% of US physicians rate it as highly effective vs 25% of physicians in other countries"
https://au.finance.yahoo.com/news/sermo-reports-worldwide-remdesivir-usage-130000262.html
Glta, Farrell
Patience Grasshopper..."fear is the only darkness"
"How do you hear these things...how is it you do not?"
The wise will prosper
and the foolish will despair
Unfortunately it was not the pre print of the peer review article and not even the RBL in vitro research.
GLTA, farrell
The pre print peer review publication of RBL data should be released at any time.
The publication almost certainly will contain raw study data, graphs, summaries, conclusions and recommendations for future studies.
Hopefully the pre print article will come out about the same time as the IND
A great segue into the human clinical trials.
GLTA Farrell
That means to me either he did not review the in vitro data reported or the only data he feels is revalent is clinical trial data.
Hopefully we can give him some good clinical trial data soon.
Good luck to all, Farrell
Thanks for making an important contribution to the boards understanding of definsins and their multiple possible mechanisms of actions against viruses. Hopefully the addition of Dr DeGrado as a scientific advisor will result in additional drug development against a multitude of viral diseases.
It is exciting to think how active Brilacidin has been shown to be against multiple pathogenic viruses by Dr Narayanan at George Mason. Then when you add Dr DeGrado's experience in building new anti bacterial definsin mimetics and expanding that skill to viruses it makes you more fully understand IPIX's full potential.
IPIX could be an antiviral drug power house.
Glta, Farrell
My guess is Brilacidin looks very attractive to Gilead. Brilicidin's human tests could eventually show Remdesivir does not add significantly to the antiviral effect.
We will have to wait and see.
Good luck,Farrell
Good point. The obvious conclusion is Gilead understands Remdesivir's deficiencies as a Covid19 drug are even more obvious now that Regeneron's "dual antibody" drug is out and they want Remdesivir to maintain some market share as a Covid19 drug.
To be competitive Gilead believes a combination with another drug may allow Remdesivir to stay in the game. Combining antivirals with different mechanisms of action makes sense.
That does not rule out a combination with Brilacidin especially since the in vitro studies suggest Remdesivir and Brilacidin are synergistic against Covid19.
Brilacidin is not an option at this stage because it has not completed human trials. Hopefully Brilacidin will be successful in human trials and be given an EUA. It would then join the other drugs which are operating under EUAs,Remdesivir, Convalescent plasma and Regeneron's antibody drug.
No drug has been approved as a treatment for Covid19 to date.
IPIX needs to get the studies done!
GLTA Farrell
Brilacidin will be given IV in its first human trial.
It is of interest Regeneron is doing a clinical trial giving their drug as a subcutaneous injection.
https://clinicaltrials.gov/ct2/show/NCT04519437?term=regeneron+sub+cutaneous&cond=Covid19&draw=2&rank=1
That may be an option for Brilacidin as more IV meds can be compounded into SC injections
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6182494/
IPIX has already mentioned the possibility of Brilacidin being given as an inhaler.Evidently an extensive amount of study is required for approval of a drug as an inhaled drug. An inhaled Brilacidin would be years away.
Remdesivir is being actively studied as an inhaled drug.
https://www.fiercepharma.com/drug-delivery/using-inhaled-remdesivir-and-a-repurposed-tapeworm-med-to-hit-covid-19-where-it
GLTA, Farrell
No my understanding of the pre IND meeting is all the data must be complete for the application to be presented. Then the FDA will review the application and data. The applicant then has an opportunity to answer any questions.
IMO the extra studies done by the RBL the last few weeks would not have been directly related to the IND application. For example the GI and fibroblast studies.
GLTA Farrell
Most people missed this portion of the September 15 PR
"In other newly conducted lab testing at the RBL, Brilacidin was shown to inhibit SARS-CoV-2 in a human intestinal epithelial cell line and in primary fibroblast cells obtained from human donors. The Company has been informed by the RBL that it is nearing completion of its in vitro testing of Brilacidin against SARS-CoV-2"
So on September 15, which I believe is the date IPIX had previously reported the preprint would be available, the RBL is not finished but is nearing completion of testing.
The sentence previous to this produced few comments:
"Brilacidin was shown to inhibit SARS-CoV-2 in a human intestinal epithelial cell line and in primary fibroblast cells obtained from human donors."
The significance of this in terms of the preprint release is these tests on intestinal cells and fibroblast cells had not been previously announced.
My conclusion is on 9/15 the RBL testing was not done. At that time the RBL was finishing other testing. Again testing they have not previously announced.
That shifts the time table back several weeks in terms of the pre print release.
My guess is we need to add 2-3 weeks to finish the studies and 2-3 weeks to organize and write the article.
My prediction is the preprint article at the earliest will be available the 3rd week of October and latest the first of November.
And we should have the inclusion of studies not previously announced.
I do not think there is a reason for IPIX invstors to be concerned with the delay. IMO it is the outcome of success. Brilacidin has been successful in its in vitro testing against Covid19. The research scientists want to study it as much as their funding allows.
JMO it is likely to be that simple. We will know for sure when we receive the pre print in a few weeks.
GLTA Farrell
I missed it . What did you find offensive?
Glta, Farrell
I agree with the earlier responses no one knows for sure ,but there seems to be a consensus that the sooner the antiviral is given the better. The key seems to be to start the antivirals as soon as possible to prevent the severe pulmonary inflammatory response which is the leading cause of mortality. I think that was why President Trump was treated with the antivirals so soon.
Brilacidin may have an advantage over the other antivirals being virucidal which should reduce the viral load much sooner which in theory will reduce the inflammatory and other complications.
We will know for sure after the human clinical trials.
Glta Farrell
others are coming soon...miracles...coming down from God
Trump video:at 1 minute
Look at the Therapeutics which I am taking right now...others are coming soon...miracles...coming down from God
Go Brilacidin Go IPIX
Glta, Farrell
https://secure.winred.com/tmagac/stand-with-potus-cond?btn=amt1&facet=3c7d1b1d131675935b6238e234e970f6f2b3fc1d&utm_medium=email&utm_source=ET_16&utm_campaign=20201004_67958_stand-with-potus-message-father-hs-oc-va_donaldtrumpjr_tmagac&utm_content=gop_direct-ask_image_contribute_main_mrc_dn
Trump was given the Regeneron drug first. In its clinical trials it is given once IV. The Remdesivir was given later and will be given once a day IV for a total of 5 days.
GLTA,Farrell
The IND and subsequent human clinical trials are for Brilacidin only.
GLTA Farrell
That conflicts with the other reports.We will have to wait for a clarification.
GLTA Farrell
Of course that means Brilacidin is next up in my opinion.
Good luck to all,
Farrell
I am surprised he did not receive Remdesivir first. That says a lot about the effectiveness of Remdeivir.
GLTA, Farrell
Evidently he is receiving Regeneron's Covid19 medication
Unfortunately this means he is worse. My family is praying for his recovery.
GLTA Farrell
What happens when the N-of-1 trial involves the president of the US? Regeneron is about to find out
Leonard Schleifer, Regeneron CEO (AP Images)
President Trump is taking a very personal interest in another experimental drug for Covid-19.
Friday afternoon, after he tested positive for coronavirus, the White House put out a statement saying that Trump had taken an 8 gram dose of Regeneron’s antibody cocktail — the high dose that appeared to do better than the low dose in terms of batting down viral loads.
Earlier in the week Regeneron — led by CEO Len Schleifer and chief scientist George Yancopoulos — had stirred a mixed response with its first cut of the data on the cocktail, essentially providing proof-of-concept data for the drug without solid evidence of efficacy in easing the path of the patients with initially mild cases of Covid-19.
While Regeneron offered some data that the drug could reduce the need for medical visits among patients with a low immune response, the numbers involved were far too low to offer any clear picture regulators normally needed for an OK. The use of the drug, though, may indicate that Trump is among the most vulnerable group.
Trump, though, said he took hydroxy long after the data pointed to its ineffectiveness. And he pushed the FDA to provide an emergency OK for convalescent plasma on thin evidence that it could work to fight the virus.
Trump’s response to the cocktail, real or simply self-declared, could have enormous consequences for Regeneron. The star antibody drug maker is seeking an emergency OK and may soon have the president in their corner if he pulls through quickly.
Any serious setbacks from here, though, may well turn Trump into an influential opponent. And right after word arrived that Trump had taken the experimental therapy, word came that he was being transferred to Walter Reed as a precautionary move — news that may well heighten fears about his condition.
So for right now, the president is a very big N of 1.
Biopharma companies don't typically like getting compassionate use requests for their drugs, seeing little upside when they work and a big downside when they don't. But as Schleifer told Katie Thomas at the New York Times: “When it’s the president of the United States, of course, that gets — obviously — gets our attention.”
Also of note: Trump had a choice in experimental antibodies. Eli Lilly touted its approach before Regeneron arrived on the scene, and their therapy — which disappointed a number of analysts on the first snapshot of data — didn't make the cut. That can't sit well at the pharma giant.
In addition to the cocktail, Trump also is taking zinc, vitamin D, famotidine,
My statement was "IND approval". Its my understanding the expedited Covid 19 FDA reviews incorporate the preIND application and the final IND review into one process.
"For the purposes of our response to the COVID-19 public health emergency, we are consolidating thetypical pre-IND meeting request and package development process into a single step."
https://www.fda.gov/media/137927/download
From the May 2020 FDA Covid 19 update
"During the current public health emergency, with the large number of potential therapeutics for COVID-19 related illness, it is essential that the review process for investigational drugs be as efficient as possible. To facilitate this, we are urging sponsors to submit a pre-IND meeting request that allows early and thorough review and discussion between the sponsor and FDA, which can lead to more rapid review of the subsequent IND and assurance of subject safety, which in turn can facilitate faster clinical trial initiation for programs that proceed to that phase. Given the range in clinical manifestations of COVID-19 and the large number of drugs and mechanisms of action being evaluated for use in this disease, the Center for Drug Evaluation and Research (CDER) has established a multispecialty, multidisciplinary team focused on review of drug development proposals. We recommend that sponsors seek initial advice under pre-IND meeting requests.5 For the purposes of our response to the COVID-19 public health emergency, we are consolidating thetypical pre-IND meeting request and package development process into a single step. For pre-IND requests for drugs that treat or prevent COVID-19, the content requests and processes described within this guidance substitute for those used in other settings, which FDA hasdescribed in the draft guidance for industry Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products(December 2017)."
..."The submission should include a detailed safety monitoring plan. There are significant safety concerns in the COVID-19 patient population, both because of risks associated with the disease and because of the potential for adverse events from the treatment that might be difficult to recognize. We recommend the use of an independent data monitoring committee (DMC).13 Sponsors should ensure there will be appropriate DMC monitoring to ensure subject safety accounting for important factors such as the expected enrollment rate, the expected lag time to analyze interim data for DMC meetings, and the frequency of DMC meetings"
Wow that's a big hint but it would include Brilacidin as well as Regeneron's covid drug.
GLTA Farrell
Trump would be considered high risk by any standard. That being said statistically he will recover without incidence.
Glta Farrell
I heard a rumor Dr Siegel has been aware of Brilacidin and the in vitro results. Perhaps the word Brilacidin will cross his lips on Fox soon.
GLTA Farrell
Another good review of masks for Covid19:
https://www.economist.com/science-and-technology/2020/05/28/masks-probably-slow-the-spread-of-covid-19
If you want to see what William Degrado is up to in relationship to his research review Pliant Pharmaceuticals where he is a co scientific founder.
https://pliantrx.com/our-team/#scientific-founders
https://pliantrx.com/publications/
Below is an extensive review of protein study review over the last few decades.
https://www.cambridge.org/core/journals/quarterly-reviews-of-biophysics/article/de-novo-protein-design-a-retrospective/FF37903868E1651D7E61A8495FB00B50
GLTA Farrell
May be the leader of the free world will receive Brilacidin and Remdesivir. After all it reduces the viral load by almost 100%. I doubt the White House doctors will hold anything back if they think it will help.
GLTA Fattell
You could be right because we have a whole series of PRs coming after IND approval.
Glta.,Farrel
Post of the day.
Perhaps Captain America , Luther and Alice will sneak into the White House and slip some Brilacidin into the President's IV to save the day.
GLTA, Farell
Current review of Covid 19 complications by medical specialty:
https://jamanetwork.com/journals/jama/currentissue
Under View points
My mother in law lives in a retirement community. Many of her reatively healthy fellow 80 and 90 year olds have not been outside since March.
Some of them were half looney before Covd19. It is certain their mental status has not improved. The consequinces of isolation on the elderly can be devastating.
Good post
Thanks for posting, Farrell
Ok then why did Remdesivir perform the animal studies?
The answer is here
"The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) added a new section 565(d) of the FD&C Act to require that FDA establish a procedure for a sponsor or applicant developing “a countermeasure for which human efficacy studies are not ethical or practicable, and that has an approved investigational new drug application or investigational device exemption” (IND and IDE, respectively) to request and receive two meetings with FDA – one meeting to discuss “proposed animal model development activities” and a second meeting prior to initiating pivotal animal studies. More MCM-related counterterrorism legislation"
https://www.fda.gov/emergency-preparedness-and-response/mcm-regulatory-science/animal-rule-information
My interpetation of the above is the animal studies are required in stead of testing on normal human volunteers which obviously would not be ethical for Covid19 {besides the fact no one is likely to volunteer for these tests}.
So we are tip toeing around the same point.
Thebottom line is Remdesivir was required to perform animal testing but after the IND approval.
I expect Brilacidin will have the same requirement
GLTA Farrell
This says it is accurate
Farrell
"Antiviral remdesivir prevents disease progression in monkeys with COVID-19
Study supports clinical testing under way across U.S.
Image shows SARS-CoV-2 emerging from cells
This scanning electron microscope image shows SARS-CoV-2 (round gold objects) emerging from the surface of cells cultured in the lab. SARS-CoV-2, also known as 2019-nCoV, is the virus that causes COVID-19. The virus shown was isolated from a patient in the U.S.NIAID-RML
What
Early treatment with the experimental antiviral drug remdesivir significantly reduced clinical disease and damage to the lungs of rhesus macaques infected with SARS-CoV-2, the coronavirus that causes COVID-19, according to National Institutes of Health scientists."
https://www.nih.gov/news-events/news-releases/antiviral-remdesivir-prevents-disease-progression-monkeys-covid-19
I look forward to being upgraded to a better stock exchange. IMO that and the news that would have us meet the qualifications for a Nasdaq listing will solve many of IPIX's problems.
JMO, Farrell
Good point about the animal trials. At this point Remdesivir remains an unapproved drug. Remdesivir's IND was granted without animal trials. Gilead was allowed to perform the Remdesivir Covid19 animal trials concurrently with their initial human trials.
Evidently the Covid19 emergency allowed the FDA to grant the Remdesivir IND without the animal studies normally required.
The Remdesivir IND for Covid19 was granted on 2/26/2020 without animal studies
THe Remdesivir animal study was reported on 4/17/2020
while the initial USA adaptive human clinical trial was reported on 4/27/2020. An earlier Remdesivir clinical trial was initiated in China but was not completed.
The Remdesivir EUA was granted on 5/1/2020
My expectation is Brilacidin will also be granted an IND without completing Covid19 animal trials, but animal trials will be required before it is approved as a new drug.
We will see what the FDA decides soon.
GLTA ,Farrell
https://www.nih.gov/news-events/news-releases/antiviral-remdesivir-prevents-disease-progression-monkeys-covid-19
https://www.niaid.nih.gov/news-events/nih-clinical-trial-shows-remdesivir-accelerates-recovery-advanced-covid-19
https://www.gilead.com/news-and-press/press-room/press-releases/2020/5/gileads-investigational-antiviral-remdesivir-receives-us-food-and-drug-administration-emergency-use-authorization-for-the-treatment-of-covid19
But, if you wait too long to build a position you may find the share price swept up by a tsunami of news.
Jmo but I can not see a probability of bad news until the trial results; and with the extensive in vitro testing being outstanding demonstrating the sensitivity of Covid to Brilacidin,I expect the trial results will have a high likelihood of success.
The charts especially of a mircocap company are not going to tell you when the pre print RBL article is going to be released,when a Cmo and Cdmo are hired,when a pre Ind is filed,when the IND is approved, when the human trial sites are selected and when the human study protocols are released.
Being short now is like standing on a cliff during a hurricane.
Jmo
Every investor has to do their own due diligence and understand their risk.
Glta, Farrell
Great point. One of the most concerning aspects of Covid19 is the long term multiorgan late complications. It seems virtually every system can be effected, brain heart, kidneys and others all well documented. The recent publication of myocarditis in athletes shows how insidious and dangerous the infection can be.
If Brilacidin proves to be safe and effective my guess is there will be a trial to see if a course of treatment will be given to asymptomatic patients after conversion to see if it can be effective in reducing these complications.
We will have to wait and see.
Good luck, Farrell
That is a good question .Ipix has not addressed her job description . My guess is she was hired to help with all 3 trials, Covid, UC and OM. Funding and personnel at this point should not allow simultaneous trials.
The PRs suggest the Covid 19 human trial is the first priority. It should be a short trial. If it is successful funding will come for future trials. Whether the Covid trial is successful or not the UC trial will get back on track soon after the Covid results are known.My guess is the UC trial will start in first quarter 2020. OM is more of a mystery. Perhaps Locust Walk is working on the answer.
Good luck, Farrell
It's not worth discussing unless you can enlighten us with your insight.
Glta Farrell
Go Ipix