Novant Health Initiates Phase 2 COVID-19 Trial with CytoDyn’s Leronlimab

Novant Health operates a fully integrated healthcare system throughout four states

VANCOUVER, Washington and WINSTON-SALEM, N.C., April 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 2 randomized clinical trial for COVID-19 patients with mild-to-moderate indications.  Novant Health is the first site in the southeastern United States to initiate this Phase 2 trial. It is the second clinical trial site in the nation.

Novant Health is an integrated network of physician clinics, outpatient facilities and hospitals that delivers a seamless and convenient healthcare experience to communities in Virginia, North and South Carolina, and Georgia. The Novant Health network cares for approximately 5 million patients annually at nearly 700 locations, including 15 hospitals and hundreds of outpatient facilities and physician clinics.

“COVID-19 is the most significant health threat of our generation,” said Dr. Eric Eskioglu, Executive Vice President and Chief Medical Officer for Novant Health. “We want to thank CytoDyn for partnering with us in this very important leronlimab clinical drug trial. With lives at risk, we are working together towards an effective treatment solution.”

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, added, “We are very pleased to work closely with Novant Health, one of the leading providers of innovative healthcare in the Southeast region of our country.  This pandemic is creating an opportunity for all healthcare professionals to collaborate in order to bring a potential therapeutic benefit to so many affected people.  Based upon the results we have seen with several New York patients, we are hopeful that leronlimab can provide a benefit to patients throughout the country.”

CytoDyn is also initiating a second COVID-19 trial this week. This trial is a Phase 2b/3 for severely ill COVID-19 patients and is for 342 patients, double-blinded with a 2:1 ratio (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.