CytoDyn’s Phase 3 Trial Demonstrates Safety, a 24% Reduction in Mortality and Faster Hospital Discharge for Mechanically Ventilated Critically Ill COVID-19 Patients Treated with Leronlimab
VANCOUVER, Washington, March 05, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing Vyrologix
(leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, reported today the Phase 3 trial of leronlimab for the treatment of severe-to-critical patients with
COVID-19 demonstrated continued safety, substantial improvement in the 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 population. 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 versus placebo.
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.
- Discharge 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.
Given the size of this critically ill population relative to the trial’s size (62 out of 384 patients), the Company has concurrently filed an additional protocol with the FDA using the existing sites from its CD12 trial to quickly enroll patients in this population during the pendency of these ongoing regulatory discussions. The Company has continued to enroll patients (45) through the open-label arm of the CD12 trial, and is working with regulators here and abroad to expedite this process.