FDA Puts CytoDyn Clinical Trials For HIV, COVID-19 On Hold

CytoDyn Inc. (OTCQB: CYDY) reported on Wednesday that its current trials for investigational drug leronlimab will be put on partial hold for its HIV program and full hold on its COVID-19 program. While the firm did not disclose the reason behind the pause, it said it is “committed to [US Food and Drug Administration] compliance.”

“We are evaluating our clinical programs and are working to resolve the issues underlying the clinical holds as soon as possible in close communication with the FDA,” said Chief Medical Officer Dr. Scott Kelly. “We will provide an update when we have additional information.”

Leronlimab is a humanized monoclonal antibody targeted against a specific receptor in a human’s T-cell to trigger an immune system response. The FDA previously granted the firm a fast track designation to use the candidate drug as a possible treatment for HIV-related diseases and metastatic cancer.

The drug is also being studied by the biotech firm as an antibody treatment for critically ill COVID-19 patients, the study of which was in phase 3.

The clinical holds will mean the firm would have to pause enrolling new patients in the trials being conducted. For patients with HIV under its program, the firm plans to transition them to other therapeutics.

Meanwhile, the pause on its COVID-19 program means no new clinical studies will be initiated until the hold is resolved. This also includes pausing the Brazil COVID-19 trials pending results from its previously scheduled data safety monitoring committee meeting.

The biotech firm said it intends to work with FDA to resolve the clinical holds as soon as possible.

CytoDyn last traded at $0.475 on the OTCQB.

Information for this briefing was found via Sedar and the companies mentioned. The author has no securities or affiliations related to this organization. Not a recommendation to buy or sell. Always do additional research and consult a professional before purchasing a security. The author holds no licenses.

Leave a Reply