Wednesday, July 13, 2022 12:19:22 PM
Several lines of evidence suggest that brilacidin may affect virion integrity and hence impact viral entry, thus positioning it well as a broad-spectrum prophylactic countermeasure solution.
Long term I believe brilacidin will pan-out as a broad spectrum antiviral, but in the short term IPIX might be able to obtain an FDA-EUA for B-COVID as a prophylaxis for pre-exposure to COVID and for those who are early in their diagnosis of COVID-19 and at high risk of hospitalization or death. (Pre-exposure/post-exposure)
FDA initially gained EUA authority in 2004to facilitate access to drugs, biologics, and diagnostics needed for emergency use, as in the case of an anthrax attack, the emergence of a deadly virus such as Ebola or Zika, and other bioterrorism events. EUAs related to those conditions have not been terminated and remain in effect, largely for several in vitro diagnostics (IVDs) and added uses for some therapeutics.
Specific authority for FDA to approve EUAs related to SARS-CoV-2 was issued by the secretary of Health and Human Services (HHS) in February 2020 to facilitate the availability and use of qualifying treatments lacking full market approval. This authority does not expire automatically as with other Public Health Service emergency policies;
https://www.pharmtech.com/view/fda-and-industry-prepare-for-transition-from-emergency-use-authorizations
As subvariants become more transmissible and threaten to make COVID vaccinations ineffective, Brilacidin's MOA as a COVID prophylactic, along with the B's potential for a therapeutic EUA. I think, will be very favorably viewed by potential suitors.
The omicron BA.4 and BA.5 subvariants now make up 80% of Covid infections across the U.S., with BA.5 emerging as the dominant version of the virus. Fauci said BA.5 is more transmissible than past variants and it substantially evades the protective antibodies triggered by vaccines, but the shots are still generally protecting against severe disease. In other words, people who are fully vaccinated might get infected and have mild to moderate symptoms, but they are unlikely to be hospitalized and even more unlikely to die from Covid.
Fauci said BA.5 doesn’t appear to carry a great risk of severe disease compared with other omicron subvariants. But as cases increase due to its greater transmissibility, some people will end up in the hospital or ICU, he said.
https://www.cnbc.com/2022/07/12/covid-hospitalizations-have-doubled-since-may-as-omicron-bapoint5-sweeps-us-but-deaths-remain-low.html?fbclid=IwAR2de-W1-eWIiDx5BEu1Rxe9T9fxQxOzaQ9yEF6vDdAxkzVF01GI4wpQX5c
Regeneron (REGEN-COV) earned $2.59B in this space in 2021.
