Cytodyn Inc (CYDY)

[DonDonDonDon]

CytoDyn tries to squeeze positive news out of a failed Covid-19 study

https://www.thepharmaletter.com/article/look-back-at-pharma-news-in-the-week-to-march-12-2021

CytoDyn really, really wanted to put its best foot forward, said Amber Tong on Endpoints News. So much so that, after sitting on unblinded Phase IIb/III data on Vyrologix (leronlimab) in Covid-19 for two weeks pending regulatory discussions, the biotech issued six press releases over the weekend, each offering a little more information or refining what was previously disclosed.

In one of them, CytoDyn acknowledged that leronlimab - an anti-CCR5 antibody that had already been turned away at the FDA’s doorsteps once - had failed the primary endpoint of lowering all-cause mortality at Day 28, as the result was not statistically significant. At best, execs implied, they would need to collect further clinical data to be ready for regulatory reviews.

Further massaging the data, execs pointed out that there were more over-65 patients taking leronlimab than placebo — leading them to conduct a post hoc “age adjustment” analysis and deduce “statistically-significant results (p-value = 0.0319)” for the primary endpoint “in participants receiving leronlimab + ‘commonly used COVID-19 treatments’ compared to participants who received ‘commonly used COVID-19 treatments’ alone in the placebo group in the overall modified intent-to-treat (‘mITT’) population.”

CytoDyn claimed it’s gotten regulators on board with the subgroup hypothesis: The UK’s MHRA is apparently willing to accept data from the open-label extension of the study, which has enrolled 45 so far. The US agency is asking for data from 140 more patients in the critically ill population, with the new primary endpoint of length of hospital stay (according to CytoDyn, leronlimab had shortened time to recovery by six days among these patients compared to placebo plus standard of care only, with a p-value of 0.005). In Canada, the company will apply to start selling the drug while clinical trials continue — with unclear prospects.