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Remdesiver failed it's first test and went on to be a highly touted therapeutic. We have a shot at another bite of the apple for sure. Next up likely a ready made nasal product imo.
I'm now looking for Leo to pr a new B anti-viral nasal product. That would either ease concerns or make them even more hyper.
Moshe Eshkol at BeaMed invented a particular smart fiber optic. Quite amazing cutting edge stuff.
Moshe Eshkol
Moshe a solid state physicist, did his PhD. Studies at the Tel Aviv University, has extensive knowledge of numerical simulations, FEA analysis and optical and mechanical design. Moshe led the development of a new type of stent for the treatment of hypertension at Vascular Dynamics. The stent is in advanced clinical trials with the potential to impact over one billion people. Moshe founded and led Asymmetric medical, where he invented the SmartFiber an asymmetric revolutionary fiber optic that redefined the use of fibers in the medical world. The SmartFiber was integrated in various products for the laparoscopy, orthopedic surgery and GYN including collaborations with Flex Inc. and TAG Medical. Moshe is also a veteran of the Israeli Air Force discharged as a Major and continues to be an active pilot.
https://www.squalusmed.com/team/
The outcome found a substantial OM market and "should Brilacidin be approved, it is highly likely it would be included in payer formularies as a pharmacy benefit".
Included by insurance very important.
Not looking to change the world, just FDA approval.
I patiently wait. I like the fact that B is under NIH development. Three cents to a dime now will look mighty nice. Tell scott I said hey.
It is great to see Dr DeGrado's name in the group. BRL anti-viral testing is progressing for sure. And as of late we saw some very good news regarding BRL anti-fungal testing.
Disagree, ABSSSI, OM and QIDP designation lead during 2014. Kevetrin never gained that kind of attention. Looking back a lot of good it did.
Qualified Infectious Disease Product (QIDP) designation was announced Dec 8 2014, so yes a run up based on that news.
Dec 05, 2014 3.3300 3.3600 3.3100 3.3500 3.3500 310,400
Dec 08, 2014 3.4100 4.6400 3.4000 4.4900 4.4900 4,264,000
Dec 09, 2014 4.5100 4.8000 4.2000 4.5000 4.5000 2,896,100
Dec 10, 2014 4.5800 4.5900 4.2500 4.5400 4.5400 1,559,300
Dec 11, 2014 4.5300 4.8900 4.4300 4.8000 4.8000 1,313,700
Dec 12, 2014 4.8100 4.9300 4.6600 4.8000 4.8000 981,400
Dec 15, 2014 4.8400 4.8600 4.3300 4.5100 4.5100 667,600
Dec 16, 2014 4.4700 4.4800 4.0700 4.1900 4.1900 1,425,400
Dec 17, 2014 4.2400 4.3500 3.7400 4.3500 4.3500 1,229,700
Dec 18, 2014 4.3300 4.4000 4.1300 4.3700 4.3700 376,700
Dec 19, 2014 4.3000 4.4200 4.1800 4.3800 4.3800 606,000
Dec 22, 2014 4.4100 4.4100 4.0100 4.1800 4.1800 800,500
Dec 23, 2014 4.2300 4.2300 3.9300 4.1900 4.1900 390,900
Dec 24, 2014 4.1600 4.3900 4.1300 4.2900 4.2900 149,400
Dec 26, 2014 4.3000 4.3700 4.2000 4.2300 4.2300 174,100
Dec 29, 2014 4.2900 4.2900 4.1000 4.2000 4.2000 386,600
No it was when Brilacidin received FDA Qualified Infectious Disease Product (QIDP) designation qualifying Fast Track and Priority Review and a reported extra 5 years of market exclusivity upon drug approval. This was news after the successful ABSSSI phase2b trial that went no where. I think Kevetrin updates made the price go down.
You mean like jumping in on that 2015 run up. Those were the days ugh:) Would like to see a bit of that now but maybe unlikely.
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.