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Humanigen Expands Phase 3 Study Of Lenzilumab In COVID-19 To Brazil - Quick Facts

Biopharmaceutical company Humanigen, Inc. (HGEN) announced Monday that the Brazilian regulatory agency, Anvisa, has granted permission to commence a Phase 3 study of lenzilumab in patients with COVID-19 in Brazil.

The approval for the Phase 3 study y Brazil's ministry of health follows IND approval granted by the U.S. Food & Drug Administration.

The study, now set to begin recruiting patients in Brazil, follows the same protocol approved by the US FDA in April. It will be a multicenter, randomized, placebo-controlled, double-blinded clinical trial focused on hospitalized severe and critical adult COVID-19 patients at high risk of disease progression.

Humanigen is working with Clinical Trial & Consulting (CTI), recently named the top global contract research organization, to conduct this trial in Brazil.

Currently, Brazil has the second highest reported rates of COVID-19 infection in the world, second only to the US.

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