Leronlimab was administered to more than sixty patients with redacted under emergency Investigational New Drug (eINDs) authorizations granted by the FDA. Preliminary results from this patient population led to CytoDyn’s Phase 2b/3 clinical trial for 390 patients, which is randomized, placebo-controlled with 2:1 ratio (active drug to placebo ratio). CytoDyn has also been granted a Phase 2 randomized clinical trial study in the U.S. for a Phase 2 randomized clinical trial for mild-to-moderate redacted population in the U.S. CytoDyn plans to update the public regarding current eIND results later this week.
“We believe the randomized head-to-head comparison of leronlimab to remdesivir and in combination will provide answers to the lingering question regarding effective treatment options for patients suffering from redacted. We look forward to working both in the United States and with potential international sites to help provide effective treatment options for redacted,” said Jacob Lalezari, M.D., Chief Science Officer of CytoDyn.
CytoDyn has assurance from its manufacturer that it will have available over 1 million vials this year and could ramp up production to 2-3 million vials this year alone,” said, Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn.