Humanigen receives preliminary topline data from NIH/NIAID study of lenzilumab in ACTIV-5/BET-B trial.
Humanigen, Inc. has been informed of preliminary topline results from the National Institute of Allergy and Infectious Diseases’ (NIAID) 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, which was defined as the proportion of patients with baseline CRP<150 mg l and age less than 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 [hr 0.72]. there were no new safety signals attributed to lenzilumab in the activ-5 bet-b study.></150>
“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 III LIVE-AIR study,” said Cameron Durrant, Chairman and Chief Executive Officer, Humanigen. “In order to prove the therapeutic benefits of immunomodulators, platform studies comprising thousands of patients have been necessary. With the continued resurgence of COVID-19, further exploration of variant agnostic treatments to improve outcomes in hospitalized COVID-19 patients should be a priority.”
About ACTIV-5/BET-B :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 development of the most promising treatments and vaccines. ACTIV is led by a working group of senior scientists representing government, industry, non-profit, philanthropic, and academic organizations and is pursuing five fast-track focus areas most ripe for opportunity, one of which is accelerating clinical testing of the most promising vaccines and treatments. Within this focus area ACTIV-5 (Big Effect Trial, BET) is a series of randomized, double-blind, placebo-controlled trials using common assessments and endpoints to evaluate whether certain therapies, approved or investigational, show promise treating patients hospitalized with COVID-19.
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