CYDY - CytoDyn's partner to submit request to conduct Phase 3 leronlimab studies in Brazil

CytoDyn's (CYDY) Brazilian distribution partner, Biomm S.A. plans to submit an authorization request to the Brazilian regulatory agency in the next few days to conduct two Phase 3 clinical trials of leronlimab in Brazil for COVID-19.The two Phase 3 trials consist of each severe and critically ill COVID-19 patients. Once approved, the Phase 3 trials will be conducted by Albert Einstein Israelite Hospital, an Academic Research Organization in Brazil. These two Phase 3 trials will be conducted in up to 45 clinical sites. The critically ill protocol is for 306 patients while the severe protocol is for 594 patients, and interim analysis for both populations will be conducted when enrollment reaches about 40% of the total number for each trial.

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CytoDyn's partner to submit request to conduct Phase 3 leronlimab studies in Brazil