Humanigen Inc (OTCQB:HGEN) said Monday that its lead drug candidate lenzilumab was selected for use in the National Institute of Health’s upcoming coronavirus trial.
The biopharmaceutical company’s lenzilumab, an anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody drug candidate, will be evaluated in the National Institute of Allergy and Infectious Diseases’ (NIAID) Big Effect Trial (BET) in patients hospitalized with COVID-19.
In a statement, California-based Humanigen said that the trial will help to advance NIAID's strategic plan for COVID-19 research, which includes conducting studies to advance high-priority therapeutic candidates and identify agents with novel mechanisms of action for therapy -- a “strategic priority” for the institute, according to Humanigen.
READ: Humanigen says lenzilumab drug delivers better recovery time for coronavirus-associated pneumonia in cross-trial analysis
"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, Humanigen’s CEO in a statement Monday.
"With data from the BET and our ongoing Phase III study, we will have data from approximately 500 hospitalized COVID-19 patients."
Teaming up for treatment
The trial will evaluate a combination of lenzilumab and Gilead Sciences’ (NASDAQ:GILD) remdesivir on treatment outcomes compared to placebo and remdesivir in hospitalized COVID-19 patients. Around 100 patients are anticipated to enroll in each branch of the study, with an interim analysis for efficacy after 50 patients have been enrolled in each branch.
Remdesivir is the first drug approved by the US to treat COVID-19 after preliminary trials indicated its effectiveness in helping patients recover faster from the disease. The antiviral drug made headlines recently when the US health department agreed to buy 500,000 doses for use in American hospitals.
As for lenzilumab, recent studies highlighted a mean recovery time nearly twice as fast as a group treated with remdesivir in a separate trial.
Shorter recovery time with lenzilumab
In a Mayo Clinic study, a group treated with lenzilumab showed a median recovery time of five days and a 100% survival rate at the data cut-off point. By comparison, a group of patients with similar baseline characteristics treated with Gilead Sciences’ remdesivir had a median recovery time of 10 to 11 days.
Lenzilumab is designed to treat the cytokine storm, an overactive immune system response that can cause fever and inflammation and potentially lead to organ failure.
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