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Prurisol is dead for sure but not Brilacidin which is hard at work killing those nasty viral and fungal buggers. Hmm If IPIX were really dead would there be board activity..
http://www.ipharminc.com/press-release/2022/10/3/innovation-pharmaceuticals-announces-publication-of-scientific-article-on-the-antifungal-activity-of-brilacidin
And the test findings have shown BRL so far as a robust anti-fungal. “It is a remarkable feature of Brilacidin that it can potentiate multiple antifungals, in different pathogenic fungi, including hard-to-treat species. New antifungal combination strategies are urgently needed due to a scarcity of novel agents, alongside emerging resistance in the clinical setting,” commented Gustavo Henrique Goldman, Professor of Molecular Biology, University of São Paulo, Brazil, and a Chief Editor for Frontiers in Fungal Biology, a peer-reviewed journal dedicated to the study of mycology. “Another notable finding from our research is that Brilacidin shows exceptional potency of its own as a monotherapy against C. neoformans, a particularly problematic fungus. We look forward to broadening our planned studies of Brilacidin’s antifungal properties.”
He clearly knows how to make it happen.
Prior to joining Anavex, Dr. Fadiran served as a Clinical Pharmacology Team Leader at the FDA’s CDER. During his 24-year (1993-2017) tenure at the FDA, Dr. Fadiran reviewed hundreds of New Drug Applications (NDAs), supplemental New Drug Applications (sNDAs), Biologics License Application (BLAs), Abbreviated New Drug Applications (ANDAs) and Investigational New Drug applications (INDs) for approval and made strategic recommendations for the development of several products across many therapeutic categories. He was on review teams for several novel therapies including first-in-class approvals. Dr. Fadiran also led a cross-disciplinary NDA review team and authored the first Cross-Discipline Team Leader (CDTL) review for the Division of the Pulmonary and Allergy Products, Office of Drug Evaluation II, CDER. He was actively involved in the writing, internal/external training and implementation of the U.S. FDA Guidance for Industry for population pharmacokinetics.
Agree. We are looking at future value here. The good thing now going forward is the earlier phase2 work proved B safe, so I think with a completed nasal formula we could go right into a phase2 trial with government support.
Remdesiver failed it first trial but went on to be standard of care in the US so in this light you can't just disregard B for not meeting it's primary endpoint in this moderate to severe trial alone, the science community clearly hasn't. B is still being studied as a broad-spectrum anti-viral (now over 20 viruses) and as a anti-fungal with reported success in both. From scientific papers we know a nasally form of B is in the works to address the virus early while it's still replicating in the airways.
June 23
"While the trial did not meet its primary endpoint in reducing time to sustained recovery through day 29, certain patient subgroups did show treatment benefits of Brilacidin for that primary endpoint. For example, patients treated early from onset of symptoms achieved sustained recovery more quickly (Brilacidin 5-dose group vs pooled placebo, p=0.03). To date, only a modicum of success has been demonstrated by any company conducting clinical trials in moderate-to-severe hospitalized cases of COVID-19. A possible reason for this may be owing to frequent changes in the standard of care with patients receiving a cocktail of fluctuating concomitant medications, which complicates the interpretation of the clinical trial data and that of the new drug candidate being evaluated. Clinical observations of COVID-19 patients treated with Brilacidin further lead us to believe that higher and more frequent dosing of Brilacidin may be more appropriate to tackle this complex disease in the hospital setting".
Testing against multiple strains of fungi, like different strains of virus also fungal strains.
Now I wonder if Leo is applying for QIDP for fungal diseases.
http://www.ipharminc.com/stages-of-development
Wow nice to see Fungal Diseases added in the pipeline.
The "nasally" formulation is being developed in GMU labs per last update. And yes no formal announcement by the company, I would sure like to see more on this. It was announced in a pr sometime back that a nasal formula was being investigated or something to that effect. I now wonder if a B inhaler developed as anti-viral could be used against fungal lung infection.
Exactly! I like the anti-fungal play and I think it's a good space for B. Looking for more news to come on this. Yep!
BRL just keeps getting better at the dismay of some.
As a anti-fungal agent on hard to treat fungal infections I think FDA would welcome B with open arms.
"New antifungal combination strategies are urgently needed due to a scarcity of novel agents, alongside emerging resistance in the clinical setting,” commented Gustavo Henrique Goldman, Professor of Molecular Biology, University of São Paulo, Brazil, and a Chief Editor for Frontiers in Fungal Biology, a peer-reviewed journal dedicated to the study of mycology. “Another notable finding from our research is that Brilacidin shows exceptional potency of its own as a monotherapy against C. neoformans, a particularly problematic fungus. We look forward to broadening our planned studies of Brilacidin’s antifungal properties.”
I'm really looking forward to them broadening their "planned" studies!!
Yes and I think noteworthy is Brilacidin has been granted Qualified Infectious Disease Product designation (QIDP)- "There is a large unmet medical need for developing novel antifungal agents, particularly given the emergence of resistance in the clinical setting. The utility of current antifungal treatments is limited due to toxicity, fungistatic and not fungicidal properties, as well as drug interaction concerns. In the United States, antifungal drugs can qualify for expedited clinical development, under Qualified Infectious Disease Product designation, Orphan Drug designation, and the limited population pathway development program. Pivotal clinical trials for antifungal drugs are generally smaller than those in other infectious disease areas, requiring between 300 and 600 patients. Caspofungin sales were estimated to be $414 million in 2021, with the global antifungal drugs market estimated at $14.8 billion in 2021 and expected to reach $20.5 billion by 2030".
Read the release they were paired together. Brilacidin plus Caspofunginon cleared infection in the lungs by almost 95 percent, compared to ~50 percent when each compound was administered individually. Pairing the two drugs changes the outcome dramatically.
Btw Caspofunginon is given intravenous like B.
Excellent synopsis CMC. Can't wait to see further updates on all this.
It's in the release. have a look.
Caspofungin sales were estimated to be $414 million in 2021, with the global antifungal drugs market estimated at $14.8 billion in 2021 and expected to reach $20.5 billion by 2030.
For what I have read B could be used on a host of different fungas.
Caspogungin is made by Merck
The Brazilian anti-fungal results are undeniably good. Go BRL
"Did anyone know that Brilicidin was being assessed by a Brazilian University until the other day? Anyone mention Brazil is mainly jungles aka Fungal infection paradise "
I never knew it. The anti-fungal data coming out of those university's looks to be very positive.
So we have further in vivo study. Good to see- In an A. fumigatus immunosuppressed mouse model in invasive pulmonary aspergillosis, Brilacidin plus CAS cleared infection in the lungs by almost 95 percent, compared to ~50 percent when each compound was administered individually.
So far..
Anti-viral nasal in vivo
Anti-fungal in vivo
Moving on up as they say.
We are in good company. BRL speaks for itself.
You can't have my shares the chart says..
It's called wanting to buy lower for the next run up but it's not happening. So dire warnings are posted. oh me.. Whats not being said is BRL is making much strides in multiple countries.
But wait there's more!! Gotta Love it. Go BRL
Found this by another poster to be quite interesting- Merck owns 2 of the 3 antifungal treatments mentioned in today’s PR (Pfizer owns the other one). One of Merck’s antifungal treatments they specifically mention, (CAS), alone only clears infection up to 50% but when combined with BRI clears almost 95% of the infection ?????? As quoted from the PR, “We look forward to broadening our planned studies of Brilacidin’s antifungal properties.” [That is a quote from one of the researchers, not IPIX.] Key word, PLANNED! The same antifungal treatment (CAS) is also the only one they specifically mention 2021 sales
What I find helpless is the ones who want IPIX to go away. BRL the onion of wonder drugs the more scientists peel back the more they find.. Antibiotic, Anti-virus, Anti-fungal and let me see oh yes Anti-inflammatory.
What I don't get is why now just out of the blue. I get the idea that with all the ongoing anti-viral testing they would now focus on anti-infection development. My thought is K could have just sat on the shelf as a future development for years. I hope this sudden change is because B has given them so much confidence to do so.
Yes. Brilacidin is currently under development and testing by NIH labs as a nasal anti-viral type inhibitor. Future catch phrase "Stopping viruses in their tracks".
As what French was saying Basilea gave up their expensive cancer program to focus on anti-infection development. With BRL's ongoing positive anti-viral developments I think Leo is doing the same now. I'm hoping this thing bears fruit soon in the form of development funding.
Wow seems they are constantly finding something new regarding Brilacidins inherent abilities. BRL could end up a block buster in time. Having the government keep funding these studies is huge imo.
Oh I see the titles are there but the body of the release(s) is missing.
Example:
February 17, 2010
Cellceutix Completes Successful Pre-IND Meeting with FDA for Cancer Drug
Turns into the following when you try to open it.:
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There is an error in the URL entered into your web browser. Please check the URL and try again.
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Yes I am aware K was discontinued per the 10-k.
You can remove it from the drug pipeline like with prurisol but the data remains. The good thing is we have B which has super computer pedigree.
Not sure what he's looking at cause I just filtered in Kevetrin and I see the press releases are still there.
http://www.ipharminc.com/press-release select Kevetrin
Yes and early on Redesiver failed slid into a deep ditch was poo pooed by NIH but yet was pulled out and resurrected by big pharma and became soc.. B has gone on to kill viruses, bacteria and now fungi being more versatile them Rem owners could have dreamed. Now we wait on B nasal formulation to kill those nasty buggers in the airway BEFORE the viruses take hold.
The scientific investigators involved have all that put their real names on these papers. Also real government funding at work.
And along the way we get some nice price appreciation too!
Patents can be changed and updated depending on drug delivery method or an additive. Leo could have just left it on the shelf and not removed it all together. Seems Leo cleared the deck for a B only future. This testing is targeting many areas and could be a huge market opportunity. B is in the hands of professionals and I like that.
"BRI overcomes the CAS-acquired resistance in both A. fumigatus
and C. albicans and the CAS-intrinsic resistance in C. neoformans. BRI also
has an additive effect on the activity of posaconazole (POSA) against several
Mucorales fungi. Cell toxicity assays and fungal burden studies in an
immunosuppressed murine model of IPA showed that BRI combined with CAS
is not toxic to the cells and significantly clears A. fumigatus lung infection,
respectively. Our results indicate that combinations of BRI and antifungal drugs
in clinical use are likely to improve the treatment outcome of IPA and other
fungal infections".
I think this is a no brainer as an inhaler for hospital use. Fungal infections are a problem in hospitals.
They are throwing B at everything. So far positive results in antibiotic, anti-viral and anti-fungal. Multiple country's involved in this.
I think Leo is just supplying B to government labs and waiting on results. The development of a nasal formulation is where we are at now. I hope B's broad-spectrum ability is the ticket.