CYDY - CytoDyn gets Brazil regulatory clearance for late-stage COVID-19 trial

CytoDyn (OTCQB:CYDY) announces that Brazil’s regulatory authority ANVISA (Agência Nacional de Vigilância Sanitária) has approved the clinical trial protocol to commence patient enrollment in the company's CD17 trial of leronlimab for severe COVID-19 patients. The late-stage trial will be conducted in up to 35 clinical sites with 612 patients who are hospitalized and in need of oxygenation support. It aims to prevent the disease from evolving into a more severe case, requiring invasive mechanical ventilation. The Phase 3 trial for severe COVID-19 patients has built in an interim analysis to be conducted after 40% (245) of the patients have been enrolled and the last-enrolled patient has completed 28 days of treatment with leronlimab. The company expects to post the results of the interim analysis to be available in the next three to four months. Shares down 1% premarket.

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CytoDyn gets Brazil regulatory clearance for late-stage COVID-19 trial