(RTTNews) – Biopharmaceutical company Humanigen, Inc. (HGEN) announced on Monday that Brazil’s regulatory agency, Anvisa, has legalized the start of a phase 3 of lenzilumab in COVID-19 patients in Brazil.
Approval of Phase 3 through Brazil’s Ministry of Health follows the approval of the IND granted through the U.S. Food and Drug Administration.
The study, which is now expected to begin recruiting patients in Brazil, follows the same protocol approved by the U.S. FDA. In April. This will be a multicenter, randomized, placebo-controlled, double-blind clinical trial targeted at adult patients hospitalized with severe and COVID-19 critical patients who are most at risk of disease progression.
Humanigen is running with Clinical Trial Consulting (CTI), recently named as the world’s leading contracted organization, to conduct this test in Brazil.
Currently, Brazil has the highest rate of COVID-19 infection in the world, only the United States.