CytoDyn Has Reached Its Enrollment Target for Phase 2 COVID-19 Trial for Mild to Moderate Indication; Primary End-Point Announcement Is Next

On June 11, 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 the company has met its 75 patient enrollment for its Phase 2 clinical trial entitled “Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19.” This Phase 2 trial evaluates clinical improvement of several symptoms over a 14-day period, including changes in multiple clinical baseline metrics after days 3, 7, and 14. CytoDyn expects the evaluation clinical patient data to be available two weeks after the last patient is enrolled. Because there are more patients who have been screened for enrollment, final enrollment is expected to exceed 75. Nader Pourhassan, PhD, President and Chief Executive Officer of CytoDyn, commented, “Based upon our understanding of clinical outcomes from severe and critically ill COVID-19 patients, we are guardedly optimistic about the potential results from the mild-to-moderate patients. Furthermore, CytoDyn will do an interim analysis of patient data in the Phase 3 trial for severe and critically ill COVID-19 patients and we hope to have these important results in 2 to 3 weeks.” CytoDyn has met its 75-patient enrollment target in its Phase 2 clinical trial for COVID-19, a randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and enrollment continues in its Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country. SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious.
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