Humanigen's Lenzilumab Disappoints In NIH-Backed COVID-19 Study

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  • Humanigen Inc HGEN has been informed of preliminary topline results from the ACTIV-5/BET-B trial evaluating lenzilumab plus remdesivir versus placebo plus remdesivir in hospitalized COVID-19 patients. 
  • The trial did not achieve statistical significance on the primary endpoint, defined as the proportion of patients with baseline CRP<150 mg/L and age<85 years, alive and without mechanical ventilation through Day 29. 
  • The data also showed a non-significant trend toward a reduction in mortality in the overall patient population.
  • There were no new safety signals attributed to lenzilumab in the ACTIV-5/BET-B study.
  • "We are grateful for the constructive collaboration with NIH/NIAID; while the ACTIV-5/BET-B study showed signs of a clinical effect, the benefit demonstrated was not able to confirm the positive results we saw in our Phase 3 LIVE-AIR study," said Cameron Durrant, Chairman and Chief Executive Officer, Humanigen. 
  • The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) is a National Institutes of Health (NIH) directed public-private partnership to develop a coordinated research strategy for prioritizing and speeding the development of the most promising treatments and vaccines. 
  • Price Action: HGEN shares are down 65.20% at $1.04 during the premarket session on the last check Wednesday.
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