Regulatory CytoDyn Voluntarily Withdraws HIV Approval, Cites Data Management Issues

CytoDyn Voluntarily Withdraws HIV Approval, Cites Data Management Issues


Biotech firm CytoDyn has announced that it has formally withdrawn its Biologics License Application (BLA) for leronlimab, which was intended to treat HIV patients who had developed resistance to active antiretroviral therapy.

The company claims that the choice was made with a number of considerations in mind, including issues with data management and collection as well as problems with the clinical research organization’s (CRO) monitoring of the crucial clinical trials. 

Although CytoDyn successfully met its endpoint in the phase 2b/3 trial – the safety and efficacy data of which it plans to make public soon –  it simply didn’t find it feasible to proceed further with the application. The company undertook as many as three data audits from independent regulatory firms, and the feedback compelled it to halt the application in its tracks.

The company states that significant extra investment is required to resolve the problems raised with the trial data and stand any chance of FDA-approval in the future. Moreover, it seems like the dispute with the CRO is far from finished, as the biotech company has filed a claim for damages.

This is just the latest issue for leronlimab in an ever-increasing list of woes. Back in July 2020, the company submitted its first application in the HIV indication, receiving no love from the FDA due to what the agency cited as a lack of necessary information. Since then, the biotech company has resubmitted certain sections of the application, which are currently being reviewed by the FDA.

This March, the company was hit by a double blow when the FDA obtained a partial hold on its HIV program and total hold on the COVID-19 program for leronlimab. At the time, CytoDyn actively searched for partners to rescue crucial programs, with no luck.

Despite the persistent problems it has faced with leronlimab, CytoDyn isn’t giving up on the drug just yet. The firm is optimistic about its future commitments regarding other overlooked HIV conditions, in addition to nonalcoholic steatohepatitis (NASH) and metastatic triple-negative breast cancer. For the latter, CytoDyn has already received a fast-track tag from the FDA.

“We plan to reenter the clinic in those indications and believe these steps will allow us to further build on the strong signals we have seen in these indications,” CytoDyn President Cyrus Arman, Ph.D., stated in a release. “I am very excited and quite optimistic about these opportunities, which are what ultimately attracted me to leronlimab and CytoDyn.”

One potential leronlimab indication that seems to be done and dusted is COVID-19, after a failed trial in 2021. The company said at the time that the drug could treat coronavirus patients, but the FDA wasn’t impressed. In fact, the agency publicly called out CytoDyn, accusing it of cherry-picking data that seemed to work in its favor and gave it grounds to label the therapy as a success.

It seems that the chaos has worked its way to CytoDyn’s senior leadership as well. Since Nader Pourhassan’s departure back in January, the biotech firm is still looking for a permanent CEO to hold the reins.

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