CytoDyn Preparing Phase 3 Protocol to Submit to FDA for Three-Arm Comparative & Combination Trial of Leronlimab and Gilead’s Remdesivir

On Monday, May 18, 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 it will be submitting a protocol to the U.S. Food and Drug Administration (FDA) for a factorial design trial to compare the effectiveness of leronlimab versus remdesivir and in combination with remdesivir for the treatment of COVID-19. Leronlimab has been administered to more than sixty patients with COVID-19 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 a randomized, placebo-controlled trial with 2:1 ratio (active drug to placebo ratio) for severe and critically ill COVID-19 population in several hospitals throughout the country. 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 COVID-19 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 COVID-19. We look forward to working both in the United States and with potential international sites to help provide effective treatment options for COVID-19,” said Jacob Lalezari, MD, Chief Science Officer of CytoDyn. “Unfortunately, COVID-19 remains a global public health challenge, and its economic impact continues to devastate the world economy.
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