As Pete mentioned today’s PR is not the one we had anticipated but it is however an excellent communique describing the breadth of opportunities for Brilacidin as a Pan-Coronavirus treatment.
The PR we are anticipating is the announcement that human B-CV19 trials have been initiated. Brilacidin as a treatment for CV19 is needed ASAP as there is currently not an effective CV19 therapeutic available. Today’s PR stated that IPIX has submitted all of the required documentation for both U.S. and overseas approvals and the ball is in the court of these prospective agencies as IPIX awaits the green light to proceed. I am personally confident that all of the preparation required from IPIX’s perspective has been fully planned and is in place (trial details, drug supply, patient profiles, dosage regime and locations), staffed (CRO and project management) and ready to immediately proceed into human trials. My guess is that international approval will happen very shortly with U.S. based FDA approval not far behind.
December starts tomorrow and I still believe Brilacidin CV19 human trials will start in December and meet the Q4 estimated goal. The entire world will know very quickly whether Brilacidin will be as effective in human patient treatment for CV19 as it was in the outstanding RBL testing results. I am expecting that we will see several PRs in regards to this with the most important one IMO being successful interim results, which I hope we see sometime in January. This would pave the way for Emergency and Compassionate Use approvals and expedite additional human trials (both stand-alone and combo) and directly lead to the final NDA approval for commercialization of Brilacidin.
The B-CV19 approval process will be the first domino that will initiate Brilacidin’s use to treat a variety of disease (franchise drug), some of which was described in today’s PR. A successful B-CV19 human trial IMO will attract both government grant funding and multiple Big Pharma interest for partnership opportunities. Funding will allow the additional dominos of multiple opportunities to follow.
Today’s PR discussed that independent research testing is ongoing for Brilacidin as a broad spectrum antiviral for treating other endemic human coronaviruses (H-CoVs) including common colds and other enveloped viruses. This independent testing is a continuation of work done at the RBL and that a separate peer review paper on Brilacidin for H-CoVs will be published. I am guessing that this RBL testing is being funded by the RBL or another 3rd party while IPIX is currently laser focused on B-CV19. Once Brilacidin is approved for B-CV19 the opportunities including it as an H-CoVs treatment are enormous for both known diseases as well as future viral threats and potential pandemics.
In the 11/16/20 PR it was noted that the RBL testing showed Brilacidin exerted potent inhibition with 2 separate strains of SARS-CoV2 highlighting that Brilacidin would not be susceptible to mutation resistance. In the 10/30/20 PR Dr. Narayanan stated in part “Brilacidin’s potential to prevent infection, upon appropriate formulation, as a prophylactic”. Note from the recent 10-Q page 28 “Partnering opportunities with industry and academic partners are ongoing regarding the COVID-19 program. The Company through discussions with industry, academic consultants, and potential partners will also explore investigation of treatment with Brilacidin by inhaled administration for the prevention of COVID-19 infection.” and “Additional grant applications incorporating the new data are planned for submission before the end of 2020.”
These statements highlight that future opportunities for Brilacidin could encompass both a multitude of disease treatment as well as the development of multiple delivery mechanisms. Funding and revenue generated from B-CV19 will also allow the advancement on targeted areas of need that were the main focus of IPIX prior to the CV19 pandemic including B-OM and the enormous opportunity of B-IBD UC and Kevetrin advancement. As farrell mentioned in a recent post “This time next year IPIX will be a very different company.” IMO this is a very exciting time to be an IPIX investor.
The PR we are anticipating is the announcement that human B-CV19 trials have been initiated. Brilacidin as a treatment for CV19 is needed ASAP as there is currently not an effective CV19 therapeutic available. Today’s PR stated that IPIX has submitted all of the required documentation for both U.S. and overseas approvals and the ball is in the court of these prospective agencies as IPIX awaits the green light to proceed. I am personally confident that all of the preparation required from IPIX’s perspective has been fully planned and is in place (trial details, drug supply, patient profiles, dosage regime and locations), staffed (CRO and project management) and ready to immediately proceed into human trials. My guess is that international approval will happen very shortly with U.S. based FDA approval not far behind.
December starts tomorrow and I still believe Brilacidin CV19 human trials will start in December and meet the Q4 estimated goal. The entire world will know very quickly whether Brilacidin will be as effective in human patient treatment for CV19 as it was in the outstanding RBL testing results. I am expecting that we will see several PRs in regards to this with the most important one IMO being successful interim results, which I hope we see sometime in January. This would pave the way for Emergency and Compassionate Use approvals and expedite additional human trials (both stand-alone and combo) and directly lead to the final NDA approval for commercialization of Brilacidin.
The B-CV19 approval process will be the first domino that will initiate Brilacidin’s use to treat a variety of disease (franchise drug), some of which was described in today’s PR. A successful B-CV19 human trial IMO will attract both government grant funding and multiple Big Pharma interest for partnership opportunities. Funding will allow the additional dominos of multiple opportunities to follow.
Today’s PR discussed that independent research testing is ongoing for Brilacidin as a broad spectrum antiviral for treating other endemic human coronaviruses (H-CoVs) including common colds and other enveloped viruses. This independent testing is a continuation of work done at the RBL and that a separate peer review paper on Brilacidin for H-CoVs will be published. I am guessing that this RBL testing is being funded by the RBL or another 3rd party while IPIX is currently laser focused on B-CV19. Once Brilacidin is approved for B-CV19 the opportunities including it as an H-CoVs treatment are enormous for both known diseases as well as future viral threats and potential pandemics.
In the 11/16/20 PR it was noted that the RBL testing showed Brilacidin exerted potent inhibition with 2 separate strains of SARS-CoV2 highlighting that Brilacidin would not be susceptible to mutation resistance. In the 10/30/20 PR Dr. Narayanan stated in part “Brilacidin’s potential to prevent infection, upon appropriate formulation, as a prophylactic”. Note from the recent 10-Q page 28 “Partnering opportunities with industry and academic partners are ongoing regarding the COVID-19 program. The Company through discussions with industry, academic consultants, and potential partners will also explore investigation of treatment with Brilacidin by inhaled administration for the prevention of COVID-19 infection.” and “Additional grant applications incorporating the new data are planned for submission before the end of 2020.”
These statements highlight that future opportunities for Brilacidin could encompass both a multitude of disease treatment as well as the development of multiple delivery mechanisms. Funding and revenue generated from B-CV19 will also allow the advancement on targeted areas of need that were the main focus of IPIX prior to the CV19 pandemic including B-OM and the enormous opportunity of B-IBD UC and Kevetrin advancement. As farrell mentioned in a recent post “This time next year IPIX will be a very different company.” IMO this is a very exciting time to be an IPIX investor.
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