Cytodyn Inc (CYDY)

[SF Anony]

I've been following Aviptadil since there seems to be quite a bit of overlap with leronlimab with respect to RANTES, the cytokine storm, etc. I came across this regarding Avaptadil's clinical study:

The study protocol enrolls patients with Critical COVID-19 and Respiratory Failure and randomly assigns them to intravenous RLF-100 or Placebo in the hopes of achieving remission from this most-serious stage of COVID-19. At the committee’s recommendation, the primary endpoint is changed to “alive and free of respiratory failure at 7-10 days.” This change in primary endpoint from mortality at 28 days is driven by the general decrease in mortality with advances in treatment for Critical COVID-19 and by initial observations in the clinical trial.

https://relieftherapeutics.com/neurorx-and-relief-therapeutics-announce-data-monitoring-committee-determination-to-continue-phase-2-3-trial-of-rlf-100-for-critical-covid-19/

Interesting that they started with Mortality at 28 days as their primary end point. That's also leronlimab's PEP for the S2C trial. Their change to "Alive and free of respiratory failure at 7-10 days" could be bad news for leronlimab, and it could be good news.

Bad news: As their press release says, it could be that advances in COVID treatment have made Mortality at 28 days a much rarer occurrence. And if that makes it difficult for leronlimab to show a statistically significant improvement in the S2C trial, it could sink the approval chances.

Good news: It could be that Avaptadil just isn't as effective in severe cases as they'd hoped, and they decided that staying with the original PEP put the trial at risk. So they decided to shoot for a bigger target. Now, if it is true that mortality rates with the SOC have decreased, and leronlimab still comes through with a statistically significant improvement, then that makes leronlimab even that much more of a unicorn, and makes the case for approval even stronger.