Long-suffering CytoDyn withdraws HIV approval application for leronlimab, blaming CRO

CytoDyn has withdrawn an approval application for leronlimab in a specific HIV indication, the latest installment in the troubled biotech’s ongoing saga to get the monoclonal antibody to market.

Despite the CCR5 antagonist meeting its primary endpoint in a phase 2b/3 trial, the biotech blamed “systemic issues” with the quality of data captured by the CRO overseeing the study for the decision to pull its application for leronlimab as a combination therapy in people living with HIV who have resistance to highly active antiretroviral therapy.

An ongoing legal battle led to CytoDyn obtaining an order for the release of the trial data, which the CRO had been withholding, according to the biotech. CytoDyn commissioned three audits of the data from independent regulatory quality firms, and their feedback was enough to make the drug developer drop its application for the HIV indication, the company said in a premarket release Monday.

Resolving the issues raised with the trial data so that the approval would stand a chance with the FDA would require “significant additional investment,” the biotech concluded. The dispute with the CRO isn’t over, either, with the biotech filing a claim for damages.

It’s only the latest in an ever-growing catalog of woes for leronlimab. The company first submitted an application in this HIV indication back in July 2020, but the FDA refused to accept it, citing a lack of necessary information. CytoDyn has since resubmitted nonclinical and manufacturing sections of the application, which the agency had been reviewing.

In March, the FDA slapped a partial clinical hold on the biotech's HIV program and a full clinical hold on its COVID-19 program for the same drug. At the time, the company sought out partners to rescue key programs, but to no avail.

The biotech said today the data it now has are sufficient to complete and submit its responses to the FDA for the removal of the clinical hold on the HIV program. CytoDyn also plans to publish the safety and efficacy data from the phase 2b/3 trial in a peer-reviewed journal, the company added.

This latest chapter is far from the end for CytoDyn’s hopes for leronlimab. The ever-optimistic biotech reaffirmed its commitments to pursuing other underserved HIV indications as well as nonalcoholic steatohepatitis and metastatic triple-negative breast cancer, where it has already secured 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., said in a release. “I am very excited and quite optimistic about these opportunities, which are what ultimately attracted me to leronlimab and CytoDyn.”

Another potential indication for leronlimab that has already fallen by the wayside is COVID-19, following a failed trial last year. CytoDyn insisted at the time that its drug could treat patients with severe disease, but the FDA publicly disagreed and called out the company for cherry-picking data to suggest the therapy was a success. After the agency blasted the company, the Department of Justice and the Securities and Exchange Commission subpoenaed CytoDyn and its executives.

Even CytoDyn’s senior leadership hasn’t been immune to the chaos. The biotech continues to search for a permanent CEO in the wake of Nader Pourhassan’s departure in January, following a memorable press conference in which he begged investors to stop trashing the FDA.