CytoDyn tries to squeeze positive news out of a failed Covid-19 study — and shares take a beating
CytoDyn really, really wanted to put its best foot forward.
So much so that, after sitting on unblinded Phase IIb/III data on 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.
Shares $CYDY slid 20.99% to $3.20 once the stock market opened on Monday.
That’s not what they chose to highlight, though.
Rather, CytoDyn zoomed in on a subgroup that accounted for 62 out of 384 patients enrolled in the CD12 trial and declared a survival benefit. Whereas the trial involved severe to critically ill patients, the company found that mechanically ventilated critically ill patients saw a 24% reduction in all cause-mortality between the leronlimab and placebo arms, without breaking down the number of deaths in either group.
“We believe these results are the best results ever achieved for this population in a Phase 3 clinical trial,” CEO Nader Pourhassan boasted in one of the statements.
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 “(s)tatistically 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.”
Not that it helped with the main outcome measure:
When age adjustment was conducted, the primary endpoint was much closer to statistically significant value. Of note, the reduction of mortality in this population of 65 years and younger leronlimab arm had more than 30% less mortality than placebo and 9% less mortality in participants over 65.
But 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 6 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.
Some of the uncertainty may be answered after CytoDyn releases detailed results on the trial, which it is planning to do later today. Or at the investor webcast scheduled right before it.
There’s just one caveat: It will be a “listen only” webcast — investors can submit their questions online.
Nader Pourhassan (Photo by Jeff Kravitz/FilmMagic for CytoDyn’s Pro)