Innovation Pharmaceuticals Inc (IPIX)

[loanranger]

The good news, the missing news and the WTF is he talking about news:
IPIX "is pleased to announce that the U.S. Food and Drug Administrations (FDA) has approved the Company’s Investigational New Drug (IND) application to proceed with initiation of a Phase 2 clinical trial of Brilacidin in hospitalized patients with COVID-19."
"The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled, multi-national, multi-center study expected to enroll approximately 120 patients with moderate-to-severe COVID-19."

That would have been a fine place to stop.


Dosage size and frequency, cohort descriptions including patient counts?
If the fact that "The trial’s primary endpoint is time to sustained recovery through Day 29***" can be provided, why not those other equally relevant and interesting details?


"Brilacidin has been shown in vitro to be effective against different SARS-CoV-2 strains (Washington and Italian), as well as multiple human coronaviruses, making it less likely to be affected by emerging mutations (in the United Kingdom, Denmark and South Africa) and further differentiating the drug from other COVID-19 treatments in development today"
This is the first time the company has referenced the "Washington and Italian" strains of SARS-CoV-2. Are those the strains that caused the 18M US cases and 317K US deaths that the Company reports in its COVID-19 Tracker?
https://ipixcovid19tracker.com/
Are they the strains that will be tested in the P2 trial? If not, what strain will be used in the trial?

And this sounds great but is now the time to be flaunting the prospects of it?
"less likely to be affected by emerging mutations (in the United Kingdom, Denmark and South Africa)"
Will the overseas trial be conducted in a location where the patients may have been infected by a virus other than THE COVID-19 virus that has caused THIS pandemic.



Can't he just run "a Phase 2 clinical trial of Brilacidin in hospitalized patients with COVID-19"? A clear positive result in such a trial (with one of those 90+% numbers that were touted in the in vitro trials) would put B right at the top of the heap. Scientists, Doctors and investors would all want a piece.

The waters have been muddied....they didn't have to be.





***What does The trial’s primary endpoint is time to sustained recovery through Day 29 mean?

The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.