CytoDyn Receives Positive DSMC Recommendation for Leronlimab Phase 3 COVID-19 Trial with No Safety Concerns
VANCOUVER, Washington, Aug. 04, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company, announced today an
independent Data Safety Monitoring Committee (“DSMC”) completed its first safety review of the ongoing Phase 3 clinical trial (CD12) in patients with severe and critical COVID-19 and reported it
saw no cause to modify the study. The DSMC reviewed compiled safety data from 149 subjects enrolled in the CD12 trial. The DSMC did not raise any concerns regarding safety and recommended that the
The Phase 3 study currently has 169 enrolled patients and the Company will conduct a full interim analysis once 195 patients are enrolled, as provided in the trial’s protocol.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “We thank the DSMC for its diligence, guidance and support. We are grateful to be less than 30 patients away from our planned interim analysis enrollment goal, and we look forward to sharing those interim efficacy results as soon as possible.”
Jacob Lalezari, M.D., CytoDyn’s Chief Science Advisor, said, “We are very pleased the DSMC reported no safety concerns in CD12, a population with very severe illness and comorbidities at study entry. We eagerly await the results of the pending full interim analysis of CD12, as well as the complete safety and efficacy results from CD10, a recently completed study of patients with mild to moderate COVID-19 illness. We believe these results will provide compelling proof of efficacy and soon provide the world with a broadly effective therapeutic option for this devastating pandemic.”
CD12 is a Phase 3 randomized, double blind, placebo controlled, adaptive design multicenter two arm study to evaluate the safety and efficacy of leronlimab in patients with severe or critical symptoms of respiratory illness caused by coronavirus 2019 infection. Patients are randomized 2:1 (two leronlimab: one placebo) to receive weekly doses of 700 mg leronlimab or placebo via subcutaneous injection. The study has three phases: Screening Period, Treatment Period and Follow-Up Period. The primary outcome measured by 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.