The CytoDyn drama is incredibly bizarre and mirrors the same level of oddity we have seen with similarly run biotechs: a highly vocal CEO, data mining that runs through the Earth’s core and even severe scrutiny from the Department of Justice (DOJ) and the Securities and Exchange Commission (SEC).
The company has for some time been working on leronlimab to treat HIV treatment and prevent graft-versus-host disease. In HIV, it’s already been embarrassed by some basic errors. And last year, it jumped on the pandemic bandwagon, believing, or at least leading investors to believe, leronlimab had a chance where so many others had failed in treating COVID patients.
With more than a sense of inevitability, the COVID gamble majorly boosted its share price from early 2020, which went from its consistent penny-stock status up to a high of more than $6 apiece last summer. The stock price has since halved and been on a rollercoaster ride.
Earlier this year, and this was no real surprise, its much-vaunted phase 3 leronlimab test in COVID patients missed its primary and all major secondary endpoints.
However, in true Rotten Tomato fashion, CytoDyn zeroed in on a patient subgroup and performed a so-called age-adjustment analysis to hail the study as evidence of leronlimab's efficacy.
It published an initial data release, then felt it needed to add a second reiterating that its creative data mining had unearthed a success where the market saw failure. The second statement explained that the treatment arm contained a higher proportion of people aged 65 years and older. Considering the mortality rate difference between those above and below this age threshold, CytoDyn performed an age-adjustment analysis on the data.
Even after applying the age adjustment, the study missed its primary endpoint and all other major secondary endpoints among patients in the modified intent-to-treat population. CytoDyn, though, stressed that the primary endpoint “was much closer to statistically significant value”. Similarly, secondary endpoints approached statistical significance.
This came in March; in May, and in an unprecedented public rebuke, the FDA accused CytoDyn of trying to cherry-pick data from two failed studies to claim the drug is effective.
“It has become clear that the data currently available do not support the clinical benefit of leronlimab for the treatment of COVID-19,” the FDA said. “None of these analyses met statistical significance when using established and reliable analytical methods that correct for multiple comparisons.”
This very public slap down from the usually reserved regulator was then followed by more trouble. In August, the DOJ and the SEC subpoenaed the company and its executives, specifically seeking documents and information related to CytoDyn’s public statements about leronlimab for COVID.
CytoDyn is also facing a class-action lawsuit that alleges the company made false and misleading statements about leronlimab's viability in COVID-19.