On Business wire:
National Institutes of Health Selects Humanigen’s Lenzilumab for its COVID-19 Big Effect Trial
Big Effect Trial (BET) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) to advance high priority therapeutic candidates for COVID-19
Lenzilumab will be evaluated in combination with remdesivir and compared to placebo and remdesivir
July 27, 2020 04:05 PM Eastern Daylight Time
BURLINGAME, Calif.--(BUSINESS WIRE)--Humanigen, Inc., (HGEN) (“Humanigen”), a clinical stage biopharmaceutical company focused on preventing and treating cytokine storm, announced that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), which is part of the United States Government Department of Health and Human Services (HHS) as represented by the Division of Microbiology and Infectious Diseases (DMID), and Humanigen have executed a clinical trial agreement for lenzilumab, the company’s proprietary Humaneered® anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody drug candidate, as an agent to be evaluated in the NIAID-sponsored Big Effect Trial (BET) in hospitalized patients with COVID-19.
BET will help advance NIAID’s strategic plan for COVID-19 research, which includes conducting studies to advance high-priority therapeutic candidates.1 Identification of agents with novel mechanisms of action for therapy is a strategic priority.
This trial builds on initial data from NIAID’s Adaptive COVID-19 Treatment Trial (ACTT) that demonstrated Gilead’s investigational antiviral, remdesivir, may improve time to recovery in hospitalized patients with COVID-19. BET will evaluate the combination of lenzilumab and remdesivir on treatment outcomes versus placebo and remdesivir in hospitalized COVID-19 patients. The trial is expected to enroll 100 patients in each arm of the study with an interim analysis for efficacy after 50 patients have been enrolled in each arm.
“We have been encouraged by the lenzilumab efficacy and safety data demonstrated in the compassionate use series in COVID-19 patients and are thrilled that NIH selected lenzilumab to be part of its Big Effect Trial,” said Cameron Durrant, MD, MBA, chief executive officer of Humanigen. “With data from the BET and our ongoing Phase III study, we will have data from approximately 500 hospitalized COVID-19 patients.”
Experience with SARS-CoV-2 indicates that infection of the respiratory tract is rapid and damage is primarily mediated by the host inflammatory response. These conditions may make it difficult to modify COVID-19 with a pathogen-directed therapeutic. Host-directed strategies that target the immune response may exert additional therapeutic benefit. Having previously published data demonstrating the ability of lenzilumab to prevent and/or treat cytokine storm, Humanigen believes lenzilumab may be synergistic in the treatment of patients with COVID-19 when used in combination with a direct-acting antiviral, like remdesivir, given the differing mechanisms of action.
News 
Market Data 
Discover 
