Novant Health Initiates Phase 2b/3 Trial with CytoDyn’s Leronlimab for Severely and Critically Ill COVID-19 Patients; FDA Has Approved 54 Emergency INDs to Allow Access to Leronlimab for Severely & Critically Ill COVID-19 Patients

On May 7, 2020, CytoDyn Inc. (OTC.QB: CYDY), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced that Novant Health (link) is initiating patient enrollment in CytoDyn’s Phase 2b/3 trial for severely and critically ill COVID-19patients. 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 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 a randomized, placebo-controlled trial with a 2:1 ratio of 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, MD, 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.
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