Some questioned if Brilacidin was ready for its upcoming FDA IND meeting and expressed concern about Brilacidin's side effects. My response follows.
The paraesthesias and elevated BP occured in the Polymedix 2a trial when Cellceutix [now IPIX] performed the the 2b trial at lower doses there were no SAEs or AEs felt to be due to Brilacidin.
IPIX has stated in their PRs Covid19 is sensitive to Brilacidin at doses even lower than the 2B ABSSSI trial. If the lower doses are used in the Covid 19 treatment protocol the explanation will be straight forward.
The data in the peer review publicaitions will be available to the FDA. The government RBL's data is sure to have more detailed data supporting the three MOA's they have allowed IPIX to release in their PR's.
Brilacidin's triple MOAs are unparalleled. Remdesivir prevents viral replication. Regeneron's monoclonal antibodies prevents viral cell wall penetration. Brilacidin prevents viral replication,viral penetration into the cell plus destroys the virus by opening the viral outer coating .
The opening of the viral coat allows Brilacidin to quickly kill the virus before it enters the cell. This virucidal MOA should allow Brilacidin to quickly lower the viral load which is likely to reduce morbidity and mortality.The 3 MOA's make resistance and the development of resistant mutations less likely
With the Covid19 pandemic and Brilacidin's RBl results, I expect the FDA to be happy to review a drug that is safer than its peers. Remdesivir has well documented liver enzyme elevations.Regeneron's monoclonal antibodies may share the common complications seen in this class of medications; new immunologic conditions,increase risk of new infections, and increase risk of malignancies such as lymphomas.
Brilacidin's properties and the pandemic should make its meeting with the FDA shorter than usual. I expect Brilaciin to be expedited in its FDA trials. I would expect a Fast tract designation.
You are correct to point out that the FDA can be finicky and fickle,but the virus continues to spread worldwide and it is an election year.
Of course drugs in the clinical trials do not always behave as expected in human trials,but the 500 patients treated in previous trials makes the chance of a surprise less likely.
Good luck,Farrell
The paraesthesias and elevated BP occured in the Polymedix 2a trial when Cellceutix [now IPIX] performed the the 2b trial at lower doses there were no SAEs or AEs felt to be due to Brilacidin.
IPIX has stated in their PRs Covid19 is sensitive to Brilacidin at doses even lower than the 2B ABSSSI trial. If the lower doses are used in the Covid 19 treatment protocol the explanation will be straight forward.
The data in the peer review publicaitions will be available to the FDA. The government RBL's data is sure to have more detailed data supporting the three MOA's they have allowed IPIX to release in their PR's.
Brilacidin's triple MOAs are unparalleled. Remdesivir prevents viral replication. Regeneron's monoclonal antibodies prevents viral cell wall penetration. Brilacidin prevents viral replication,viral penetration into the cell plus destroys the virus by opening the viral outer coating .
The opening of the viral coat allows Brilacidin to quickly kill the virus before it enters the cell. This virucidal MOA should allow Brilacidin to quickly lower the viral load which is likely to reduce morbidity and mortality.The 3 MOA's make resistance and the development of resistant mutations less likely
With the Covid19 pandemic and Brilacidin's RBl results, I expect the FDA to be happy to review a drug that is safer than its peers. Remdesivir has well documented liver enzyme elevations.Regeneron's monoclonal antibodies may share the common complications seen in this class of medications; new immunologic conditions,increase risk of new infections, and increase risk of malignancies such as lymphomas.
Brilacidin's properties and the pandemic should make its meeting with the FDA shorter than usual. I expect Brilaciin to be expedited in its FDA trials. I would expect a Fast tract designation.
You are correct to point out that the FDA can be finicky and fickle,but the virus continues to spread worldwide and it is an election year.
Of course drugs in the clinical trials do not always behave as expected in human trials,but the 500 patients treated in previous trials makes the chance of a surprise less likely.
Good luck,Farrell
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