Novant Health Initiates Phase 2b/3 Trial with Cyto

Novant Health Initiates Phase 2b/3 Trial with CytoDyn’s Leronlimab for Severely and Critically Ill COVID-19 Patients
Download as PDFMay 07, 2020 6:18pm EDT
FDA has approved 54 Emergency INDs to allow access to leronlimab for severely and critically ill COVID-19 patients
VANCOUVER, Washington and WINSTON-SALEM, N.C., May 07, 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 that Novant Health is initiating patient enrollment in CytoDyn’s Phase 2b/3 trial for severely and critically ill COVID-19 patients.

Leronlimab has been administered to 54 severely and critically ill COVID-19 patients thus far under Emergency Investigational New Drug (EINDs) authorizations granted by the U.S. Food and Drug Administration (FDA). Preliminary results from this patient population led to the FDA’s recent clearance for CytoDyn’s Phase 2b/3 clinical trial for 390 patients, which is randomized, placebo-controlled 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.

“We’re grateful for our partnership with CytoDyn and the opportunity to bring cutting edge, innovative and investigative treatments to our community,” said Eric Eskioglu, M.D. Executive Vice President and Chief Medical Officer for Novant Health. “Since initiating the leronlimab mild/moderate last month, Novant Health has screened nearly 400 patients for eligibility. A number of these patients have been enrolled and treated on the mild/moderate clinical trial. Expanding treatment options for our more critically ill patients is a vital step in our fight against COVID-19. We are encouraged by early reports of efficacy of leronlimab from critically ill patients treated under an Emergency Use IND and we are eagerly awaiting the full results of both blinded studies for leronlimab in the near future from CytoDyn.”

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, added, “We are once again very pleased Novant Health is seeking to partner with our health care professionals to help provide a potential therapeutic benefit to these COVID-19 patients. Thus far, we are grateful for the benefits leronlimab has provided to so many patients, as expressed to us by their families.”