Humanigen, a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm,’ announced that the first patient has been dosed at the Emory University School of Medicine in Atlanta, Georgia as part of the in the ACTIV-5 “Big Effect Trial” (ACTIV-5/BET) evaluating lenzilumab with remdesivir, compared to placebo and remdesivir, in patients hospitalized with COVID-19.
Lenzilumab is the Company’s lead product candidate and proprietary Humaneered anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody designed to optimize antibody properties.
ACTIV-5/BET, which is being conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH), is designed to determine whether certain approved therapies or investigational drugs in late-stage clinical development show promise against COVID-19 and, therefore, merit advancement into larger clinical trials.
The adaptive, randomized, double-blind placebo-controlled trial evaluating lenzilumab with remdesivir will include up to 200 patients across as many as 40 treatment centers in the U.S. There will be approximately 100 patients assigned to each study arm.
“Nearly 90% of hospitalized COVID-19 patients progress to severe disease including the cytokine storm for some patients,” said Vincent C. Marconi, MD, professor of medicine and global health in Emory University School of Medicine and Emory’s Rollins School of Public Health. “There is a critical need for a novel COVID-19 therapeutic with potential to reduce patients’ time to recovery, and this study aims to streamline the pathway to finding these urgently needed treatments.”
“We are encouraged by lenzilumab’s efficacy and safety data demonstrated in hospitalized COVID-19 patients to date and believe we have a game-changing treatment with frontline potential,” said Cameron Durrant, MD, MBA, chief executive officer of Humanigen. “We are eager to put lenzilumab through further rigorous testing in this NIH ACTIV-5 study as we continue to advance our lead candidate in the next phases of development.”
ACTIV-5/BET is being conducted in collaboration with the NIH’s public-private partnership Accelerating COVID-19 Therapeutic Innovations and Vaccines (ACTIV) program. The ACTIV partnership has evaluated approximately 400 therapeutic agents with a potential application for COVID-19 and developed a collaborative framework for prioritizing the most promising candidates, streamlining clinical trials, coordinating regulatory processes, and leveraging assets among all partners to rapidly respond to the COVID-19 and future pandemics. To date, ACTIV has designed five adaptive master protocols for ACTIV clinical trials, and selected numerous NIH-supported networks to launch these clinical trials to test prioritized therapeutic candidates.
The primary purpose of ACTIV-5/BET, a randomized, double-blind, placebo-controlled trial, is to evaluate the clinical efficacy of the different investigational therapeutics relative to the control arm in hospitalized adults based on the patients’ clinical status at day 8. The study’s secondary point of evaluation is to evaluate the clinical efficacy of the different investigational therapeutics as assessed by the amount of time it takes for each patient to recover from COVID-19.
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