First Patient Treated with Leronlimab in Phase 2b/3 Trial for COVID-19

The Company’s Phase 2b/3 trial is for patients with severe and critically ill COVID-19 indications. Interim analysis will be conducted after results for first 50 patients are available.

VANCOUVER, Washington, April 15, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the treatment of the first patient with leronlimab in its Phase 2b/3 trial for severe and critical COVID-19 indications.  About 30 patients have been administered leronlimab under Emergency Investigational New Drug (EIND) authorizations granted by the U.S. Food and Drug Administration (FDA) and about 15 patients have been enrolled in our current Phase 2b mild-to-moderate COVID-19 patients.

The Company recently received clearance from the FDA to commence enrollment in this Phase 2b/3 clinical trial for severe and critically ill COVID-19 patients. The Phase 2b/3 trial is for 390 patients, double blinded with 2:1 ratio (active drug to placebo ratio). Patients enrolled in this trial are expected to be administered leronlimab for two weeks with the primary endpoint being the mortality rate at 28 days and a secondary endpoint of mortality rate at 14 days. The Company will perform an interim analysis on the data from 50 patients.

Concurrently, the Company has about 15 patients enrolled in its Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S.  Thus far, over 30 COVID-19 patients have been treated with leronlimab in hospitals and clinics throughout the country. 

Bruce Patterson, M.D., Chief Executive Officer and founder of IncellDx, a diagnostic partner and an advisor to CytoDyn, commented, “We are very excited to start our Phase2b/3 trial in patients with severe COVID-19. Based on the promising results from the EIND patients, we are hopeful that this randomized, placebo-controlled trial will give us the data needed for FDA approval and ultimately the basis to use leronlimab to save lives in this pandemic.”

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, said, “We continue to support the medical community’s increasing demand for leronlimab and are pleased for the severely ill patients now enrolling in our Phase 2b/3 trial.  We are hopeful that they will experience like therapeutic benefits demonstrated by many similar patients treated under EINDs. We are humbled by the dedication and courage exhibited by our medical professionals every day in their tireless efforts to combat this horrific pandemic.”