Replies to post #331342 on Innovation Pharmaceuticals Inc (IPIX)

[LilyGDog]

Thanks for you thoughts farrell90.

Go Leo & IPIX!

Instead of a placebo the other arm will receive treatment either Remdesivir, Favipiravir or convalescent plasma. There is not likely to be a combination arm in this relatively small trial.

It will be interesting to see the dosing regimen approved by the FDA.

We know Brilacidin has a long half life with a short time to virolysis.It also is effective in vitro at low doses. Will the FDA opt for 1,2 or 3 infusions or 2 arms with different doses?
My guess is 2 different doses given 2 or 3 infusions 2-3 days apart.
Fortunately they have experienced researchers to work these matters out.

What will the end points be? The in patient study most likely will evaluate treatment in hospitalized patients on low levels of oxygen without signs of imminent pulmonary failure.

If you are really confident the first end point will be lower mortality[ which no antiviral drug has achieved]if not time to recovery second will be reduced percentage to pulmonary failure or shorten tim oxygen was required and the last will be time to virus neutralization in hospitalized patients .

We should have more details of the human clinical trials in 2-3 weeks. The trial will be short.

For comparison review the Remdesvir Adaptive Covid-19 Treatment Trial (ACTT-1)trial:

https://www.nejm.org/doi/full/10.1056/NEJMoa2007764

GLTA Farrell

[DaubersUP]

Thanks Farrell. Appreciate your thoughts
It will be interesting to say the least.

[loanranger]

"Instead of a placebo the other arm will receive treatment either Remdesivir, Favipiravir or convalescent plasma."


"The FDA provided feedback on clinical development plans for the evaluation of Brilacidin as a treatment for COVID-19. The Company is now incorporating this feedback and finalizing the trial protocol for its planned Phase 2, randomized, double-blind, placebo-controlled, multi-national study to evaluate the efficacy and safety of Brilacidin in hospitalized patients with COVID-19."
http://www.ipharminc.com/press-release/2020/11/2/innovation-pharmaceuticals-receives-pre-ind-response-from-fda-on-covid-19-trial


The most highly respected contributors here have a duty to also be the most careful.

[petemantx]

I would have thought that after the first dose of Brilacidin that the reduction in viral load could be tested and that would be the positive indication if B was working or not as the reduction in all patients should he huge.

I wasn't aware other treatments were doing that well in reducing the viral load or indeed reducing it at all.

Also don't see what going up against drugs in the other arm really shows as all patients are different. Trump did well w/ Regeneron/EI Lilly treatment and shortly thereafter both trials for those antibody products were ended as being non-effective.

I have faith in Brilacidin working, just questions as to some of the parameters of the trial. But if our medical team is happy with the trial parameters it must be OK.