CytoDyn Announces Clinically Significant Top-line Results from Its Phase 2 Trial of Leronlimab in Mild-to-Moderate COVID-19 Patients; Results “Bode Well for Leronlimab’s Activity In Patients With More Severe Illness,” Senior Science Advisor Says

On August 11, 2020, CytoDyn Inc. (OTC.QB: CYDY), a late-stage biotechnology company headquartered in Seattle, Washington, announced the Top-Line results from its recently completed, randomized, double-blind, Phase 2 trial of leronlimab for COVID-19 patients with mild-to-moderate symptoms. The primary endpoint showed early clinical improvement in symptom score at Day 3 in patients receiving leronlimab. In addition, leronlimab also demonstrated statistically significant improvement versus placebo in key secondary efficacy endpoint, National Early Warning Score 2 scale (NEWS2). The results will be reported to the United States FDA, the United Kingdom MHRA, and the European Union regulatory agency, EMA. Harish Seethamraju, MD, Lead Principal Investigator at Montefiore Medical Center, New York City, stated, “The results demonstrate that CCR5 blockade by leronlimab given as a weekly subcutaneous injection in mild-to-moderate COVID-19 patients is reasonably safe and associated with rapid improvement in viral symptoms with fewer adverse events than when compared to placebo.” Nader Pourhassan, PhD, President and Chief Executive Officer of CytoDyn, stated, “In the mild- to-moderate population, it is important to have a therapeutic option for COVID-19 in patients who are showing signs of rapid clinical deterioration. Patients receiving leronlimab showed a statistically significant improvement using NEWS2 clinical parameters. We will make a case for immediate approval of leronlimab for this population of COVID-19 patients, not only in the U.S., but also in the UK and other countries around the world.” Scott A. Kelly, MD, Chief Medical Officer of CytoDyn, said, “We are thrilled with the results of leronlimab in mild-to-moderate COVID-19 patients.
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