Study modification may enable Humanigen to use ACTIV-5/BET-B as a confirmatory study to support a future Biologics License Application (BLA)
Approximately half of the 400 patients are already enrolled in ACTIV-5/BET-B

BURLINGAME, CALIF.-- August 02, 2021 -- 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.

“We appreciate the close collaboration with NIH on this important study,” said Adrian Kilcoyne, MD, Chief Medical Officer, Humanigen. “The ACTIV-5/BET-B study design has been adapted to align with the design of LIVE-AIR and may help support a future BLA for lenzilumab.”

“Sharing the same endpoint as the LIVE-AIR study, the ACTIV-5/BET-B study reinforces the potential for lenzilumab to treat hospitalized COVID-19 patients,” said Vincent Marconi, MD, Professor of Medicine at Emory University School of Medicine. “At Emory University, a key center in both the LIVE-AIR and ACTIV-5/BET-B studies, we believe these trials can identify the optimal patient population for lenzilumab. LIVE-AIR showed us that COVID-19 patients who at baseline had a CRP of less than 150 mg/L and are under 85 years of age had the greatest response to lenzilumab. Using CRP as a biomarker to identify COVID-19 patients at risk for disease progression, in whom lenzilumab treatment can be initiated prior to full blown cytokine storm, would be lifesaving.”

“ACTIV-5/BET-B may provide prospective validation for lenzilumab in the treatment of COVID-19,” said Cameron Durrant, MD, Chief Executive Officer, Humanigen. “We believe ACTIV-5/BET-B, along with LIVE-AIR, will provide the sufficient size and statistical power typically required for a BLA to be submitted to FDA.”