CYDY - CytoDyn to submit CD12 trial data to regulatory agencies in multiple countries

CytoDyn (CYDY) intends to submit the results of the completed topline report of its CD12 Phase 3 clinical trial for severe to critically ill COVID-19 patients to various regulatory agencies including India and Philippines.The results of the trial were previously shared in March. In the leronlimab arm, mortality rate was 78% lower than patients receiving placebo, and after the second dose, leronlimab achieved maximum benefit of 82% less mortality.The company says that even though the trial failed to meet the primary endpoint in the mITT (modified intention-to-treat) population, almost all of its secondary endpoints were achieved in critically ill subpopulation (62 patients) based on finalized data analysis.For secondary endpoints, CytoDyn disclosed the following p-values.All-cause mortality at day 14 (p =0.0233).Proportion of patients achieving a category of 6 or higher on a 7-point ordinal scale at days 14 and 28 (p=0.036 & 0.038).Change in clinical status of subject at day 14 on a 7-point ordinal scale (p=0.02).Length of

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CytoDyn to submit CD12 trial data to regulatory agencies in multiple countries