CytoDyn completes enrollment in Phase 3 trial for severe-to-critical COVID-19

 

• CytoDyn Inc. (OTCQB:CYDY) announces the full enrollment of its Phase 3 registrational trial for Vyrologix™ (leronlimab-PRO 140) in severe-to-critical COVID-19.
• The company is also finalizing a EUA application with the Philippine FDA with patient data from CD10 and recent eINDs for severe-to-critical patients.
• Generating statistically significant results for NEWS2, CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a double-blinded, randomized clinical trial for mild-to-moderate patients in the U.S.
• 390 patients are randomized to receive weekly doses of 700 mg leronlimab, or placebo in the two-arm, randomized, double-blind, placebo-controlled, adaptive design multicenter study which has three phases: Screening Period, Treatment Period, and Follow-Up Period.
• The patient data will be analyzed in approximately 28 days, with results to be announced soon after in mid-January 2021.
• The primary outcome measured in this study is: all-cause mortality at Day 28 with secondary outcomes being (1) all-cause mortality at Day 14, (2) change in clinical status of subject at Day 14, (3) change in clinical status of subject at Day 28, and (4) change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14.
• CytoDyn is targeting multiple therapeutic applications for leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor, suspected to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH.
• https://seekingalpha.com/news/3644685-cytodyn-completes-enrollment-in-phase-3-trial-for-severe-to-critical-covidminus-19