On March 05, 2021, CytoDyn Inc. (OTC.QB: CYDY), a late-stage biotechnology company developing Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, reported that the Phase 3 trial of leronlimab for the treatment of severe-to-critical patients with COVID-19 demonstrated continued safety, substantial improvement in survival rate, and faster hospital discharge in critically ill COVID-19 patients. The trial’s data has been reported to the U.S. Food and Drug Administration (FDA), the U.K.’s Medicines & Healthcare product Regulatory Agency (MHRA) and Health Canada (HC), and the company is in discussions with each to determine the best path forward for approval of leronlimab for treatment of COVID-19 in critically ill populations. A manuscript of the trial’s data is being prepared and will be submitted for publication in one or more major medical journals. Highlights from the trial’s data for this critically ill population include the following:
--Survival Benefit: There was a 24% reduction in all-cause mortality (primary endpoint of the study) in the leronlimab arm versus the placebo arm of the study.
--Shortened Time to Recovery: The average length of hospital stay was reduced by 6 days for patients who received leronlimab with "commonly used COVID-19 treatments,” also referred to as “Standard of Care” or “SoC,” compared to placebo patients who received SoC only, with a statistically significant p-value of 0.005.
--Discharged Alive: In addition, patients who received leronlimab demonstrated an improved probability of "discharged alive" at Day 28 (28% versus 11%), a 166% better rate than in the placebo group.
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