Therapy Areas: Infectious Diseases
National Institutes of Health Selects Humanigen's Lenzilumab for its COVID-19 Big Effect Trial
29 July 2020 - - The National Institute of Allergy and Infectious Diseases (NIAID) and US-based biopharmaceutical company Humanigen, Inc 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 in hospitalized patients with COVID-19, the company said.

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 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.

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.

Humanigenis developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases via its novel GM-CSF neutralisation and gene-knockout platforms.
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