CytoDyn Receives Positive DSMC Recommendation after Interim Analysis for Leronlimab Phase 2b/3 COVID-19 Registrational Trial
October 20, 2020 6:00am EDT
DSMC recommends CytoDyn continue the study as planned, with the protocol defined sample size and power to achieve the primary endpoint
DSMC also requests another data review when enrollment reaches 293 patients (75%) to analyze all data, including survival rate at 42 days
VANCOUVER, Washington, Oct. 20, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today recommendations from the Data Safety Monitoring Committee (DSMC) following its review of the interim analysis of the Company’s Phase 2b/3 registrational trial in patients with severe-to-critical COVID-19. The interim analysis was performed on data from the first 195 (50%) of 390 planned patients.
The DSMC had three recommendations to consider following its review of the interim analysis:
Stop the trial due to safety concerns;
Continue the trial with modification (i.e., increase the sample size to maintain the power to achieve the primary endpoint); or
Continue the study as planned, with the protocol defined sample size and power to achieve the primary endpoint.
The DSMC recommends the trial continue without modification to achieve the primary endpoint and requests another interim analysis when enrollment reaches 75% level (or 293 patients) to review patient mortality and other clinical outcome data between the two study arms (leronlimab vs. placebo). Trial enrollment is currently at 230 patients. The Company is working diligently to accelerate patient enrollment in the U.S. and U.K. to achieve the enrollment goal of 293 patients as quickly as possible (potentially in 4-6 weeks), with the goal of full enrollment (390) before year end. Clinical trial sites in the U.K. are expected to initiate enrollment in the coming days.
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.
CytoDyn’s President and Chief Executive Officer, Nader Pourhassan, Ph.D., stated, “We are grateful to the DSMC members for their diligence, guidance and support. We are very pleased by the DSMC’s recommendation and this encouraging interim analysis adding to the promising data already demonstrated with emergency INDs in over 60 severe and critical COVID-19 patients. Concurrently, we are seeking ongoing guidance from the U.S. Food and Drug Administration and regulatory agencies in other countries for a swift regulatory approval pathway for leronlimab to treat COVID-19.
During today’s webcast, we will discuss in depth all of our priorities dedicated to advancing leronlimab as a therapeutic for COVID-19 and all of the opportunities that could be available to us in the coming months.” Dr. Pourhassan added, “We look forward to providing additional information during today’s webcast.”
About Coronavirus Disease 2019
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. which produced statistically significant results for NEWS2. Enrollment continues in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population in several hospitals throughout the U.S.; an interim analysis on the first 195 patients was conducted mid-October.