CytoDyn Completes Enrollment for Phase 3 Registrational Trial for 390 Patients with Severe-to-Critical COVID-19

CytoDyn is simultaneously finalizing an EUA application with the Philippine FDA with patient data from CD10 and recent eINDs for severe-to-critical patients

VANCOUVER, Washington, Dec. 15, 2020 (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, announced today it had reached full enrollment in its Phase 3 registrational trial for patients with severe-to-critical COVID-19. The 390-patient data will be analyzed in approximately 28 days, with expected results to be announced shortly thereafter.

On October 20, 2020, following review and recommendation by the Data Safety Monitoring Committee (DSMC) of data from 195 patients, the Company continued the trial without modification to achieve the primary endpoint. The DSMC also requested a second review of the data after 75% (or 293) of the patients were enrolled and completed a 42-day post-enrollment period. The Company has concluded it will be far more time efficient to forego the second interim analysis and to analyze the data on 390 patients and to provide final data to the U.S. Food and Drug Administration, Health Canada, U.K.’s MHRA, and Philippines FDA, as soon as it is available.

CytoDyn’s Phase 2b/3 trial to evaluate the efficacy and safety of leronlimab for patients with severe-to-critical COVID-19 indications is a two-arm, randomized, double blind, placebo controlled, adaptive design multicenter study. Patients are randomized to receive weekly doses of 700 mg leronlimab, or placebo. Leronlimab and placebo are administered via subcutaneous injection. The study has three phases: Screening Period, Treatment Period, and Follow-Up Period. The primary outcome measured in this study is: all-cause mortality at Day 28. Secondary outcomes measured are: (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.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We are very thankful for the concerted efforts by so many healthcare professionals to reach full enrollment so quickly in these trying times. To the best of our knowledge, we are the first company to complete a Phase 3 trial for COVID-19 severe-to-critical population. Currently, there are hundreds of thousands of patients around the globe with an immediate need for a safe and efficacious therapeutic to combat this horrific pandemic. Since the Philippine FDA has relaxed the criteria of EUA for any safe drug with any efficacy data, we will file our EUA as soon as the presidential order is implemented by the Philippine FDA with all of the information we currently have available, which we believe could occur within the next couple of weeks. The Company is working diligently to ensure a sufficient supply of drug product is available to meet the urgent needs of patients.”