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

CytoDyn Inc. (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 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

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