CytoDyn: DSMC Recommends To Continue Leronlimab COVID-19 Registrational Trial
(RTTNews) - CytoDyn Inc. announced recommendations from the Data Safety Monitoring Committee 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 Committee recommended the trial continue without modification to achieve the primary endpoint and requested another interim analysis when enrollment reaches 75% level (or 293 patients) to review patient mortality and other clinical outcome data between leronlimab and placebo.
The company'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.
CytoDyn's CEO, Nader Pourhassan, said: "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."
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