NIH Advances ACTIV-5/BET-B Trial Evaluating Lenzilumab from a Phase 2 Exploratory Study to a Phase 2/3 Study for the Treatment of COVID-19
Excerpt from the Press Release:
BURLINGAME, Calif.–(BUSINESS WIRE)–Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company developing a first-in-class GM-CSF neutralizing antibody to prevent and treat an immune hyper-response called ‘cytokine storm’ across multiple therapeutic indications, has announced that the NIH has advanced the ACTIV-5/BET-B study to a Phase 2/3 study and modified the primary endpoint to survival without ventilation (“SWOV”), the same endpoint used in the Phase 3 LIVE-AIR study.
The amended ACTIV-5/BET-B study now includes 400 patients overall. Up to sixty US sites will be participating in the study. Humanigen is providing lenzilumab and assisting the NIH to achieve the timely completion of the study. NIH is sponsoring and funding this study.
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