FDA Says CytoDyn’s HIV Drug Leronlimab Shows No Benefit for COVID-19

The FDA refuted CytoDyn’s claims about the efficacy of the company’s experimental HIV drug leronlimab as a COVID-19 treatment based on data from two late-stage trials.

The FDA’s rebuke followed months of CytoDyn’s CEO Nader Pourhassan repeatedly offering statements about the therapy in press releases and interviews touting the therapy’s benefits.

In a rare direct statement posted online, the agency said data from two phase 3 trials showed the monoclonal antibody offered no benefit for treating mild-to-moderate and severe COVID-19 infections and that the drug was no more effective than a placebo.

“With the conclusion of [the two] clinical trials, it has become clear that the data currently available do not support the clinical benefit of leronlimab for the treatment of COVID-19,” the agency said.

The FDA highlighted the company’s analysis, indicating that leronlimab “demonstrated a mortality benefit in certain patients,” but said the drugmaker relied on a small subset of the participants in one trial and that the data did not meet statistical significance.

“If CytoDyn plans further studies of leronlimab to determine whether the drug can provide clinical benefit to individuals with COVID-19, FDA will continue to provide advice to the company on their development program,” the agency said.

CytoDyn doesn’t appear to be deterred by the FDA’s lack of confidence in the results of the late stage trials. The drugmaker released a statement yesterday continuing to tout leronlimab’s efficacy in reducing COVID-19 mortality and asserting it would seek approval from global regulators, including in the Philippines and India.

“We are very excited for the opportunity to receive our first approval in multiple countries in great need of leronlimab,” Pourhassan said, adding “We are very confident this approval will happen this year.” ― Jason Scott