CytoDyn reaches patient quota for Phase 3 leronlimab coronavirus trial; analysis expected in four weeks

CytoDyn Inc (OTCQB:CYDY) announced Tuesday that it has enrolled the requisite 195 patients in its Phase 3 trial of leronlimab in severe-to-critical coronavirus (COVID-19) patients.  Now that the patient threshold has been reached, the company will provide its first analysis after 28 days of treatment. Final results are expected in mid-October. The Phase 3 double blind, placebo controlled study is designed to evaluate the safety and efficacy of leronlimab in patients with severe or critical symptoms of respiratory illness caused by COVID-19. Patients are randomized 2:1 (two leronlimab:one placebo) to receive weekly doses of either 700 milligrams of leronlimab or a placebo through subcutaneous injection. READ: CytoDyn to submit leronlimab application questions to FDA; gets nod from UK regulators to proceed with coronavirus trial The primary endpoint of the study is the mortality rate after 28 days, and secondary endpoints include changes in clinical status and changes in Sequential Organ Failure Assessment (SOFA) score. “We are very thankful for the many clinicians and their staff who have worked tirelessly to advance enrollment this quickly and for their care of these seriously ill patients,” CytoDyn CEO Nader Pourhassan said in a statement. “We are eager to perform an interim analysis of the data and remain optimistic the interim results will be consistent with those experienced by patients who received leronlimab through multiple [Emergency Investigational New Drug Applications] (over 60) previously authorized by the FDA.” If everything goes to plan, CytoDyn is well-positioned to begin distribution of leeronlimab to patients in the US, Pourhassan said. Earlier this month, an independent safety review of its ongoing Phase 3 clinical trial of leronlimab found no concerns and recommended the trial continue, the company said. The review was conducted by the Data Safety Monitoring Committee (DSMC), which looked at compiled safety data from 149 patients enrolled in the trial at the time. Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com Follow him on Twitter @andrew_kessel