After an RTF and some stern warnings, FDA slaps CytoDyn with two clinical holds
CytoDyn’s colorful and infamous CEO may be gone, but the issues that began festering during his long reign are very much here to stay.
The biotech disclosed two FDA clinical holds on its lead drug, the CCR5 antagonist leronlimab, after market close on Wednesday: a partial hold on the HIV program, and a full one on the Covid-19 program. As a result, some patients on HIV extension trials will have to be transitioned to other therapy options, while CytoDyn would not be able to start new Covid-19 trials in the US.
While CytoDyn did not go into detail about the reasons for the holds, it’s not the first time regulators have reprimanded the company, a one-time penny stock that capitalized on the pandemic and soared to record heights before crashing back down.
Under former CEO Nader Pourhassan, CytoDyn became known for its aggressive — bordering on the reckless — promotional campaigns, pumping press release after press release to tout the (unsubstantiated) potential of leronlimab as a Covid-19 treatment. At the same time, Pourhassan went on webcasts and recorded videos to talk up the drug, undeterred even after the FDA rejected a BLA for its use in HIV, its original indication, and the drug failed a pair of Covid-19 studies.
Anything, according to the company at the time, could be positive news, whether it’s starting a compassionate use program for leronlimab in the Philippines or winning a court fight against its clinical trial service provider.
In the wake of the Covid-19 flop (and subsequent communications from CytoDyn trying to spin the results as positive), the FDA issued a rare public rebuke, explaining the trials failed on all endpoints.
Earlier this year, the agency’s Office of Prescription Drug Promotion sent another harsh warning for a promo video in which Pourhassan again made claims about leronlimab that were not backed up by data.
It got so out of hand that both the SEC and the Department of Justice decided to intervene, issuing subpoenas to look into its promotion and marketing practices.
In an attempt to redeem itself and actually up the chances of approval and commercialization, CytoDyn ousted Pourhassan and put the CFO in charge as the board set up a search for a new chief.
The biotech said it is now in the process of evaluating which programs to prioritize.
As part of that effort, CytoDyn paused its Brazil Covid-19 trials pending results from a data safety monitoring committee meeting and will reconsider the timing of its HIV BLA resubmission.