Dosing underway in mid-stage study of Humanigen's lenzilumab in COVID-19

• The first participant has been dosed in an NIAID-sponsored 200-subject Phase 2 proof-of-concept clinical trial, ACTIV-5/BET-B, evaluating Humanigen's (NASDAQ:HGEN) lenzilumab, combined with Gilead Sciences' (NASDAQ:GILD) Veklury (remdesivir), in hospitalized adult COVID-19 patients.
• The primary endpoint is clinical efficacy compared to placebo + remdesivir as measured by an eight-point ordinal scale at day 8.
• Clinical status ordinal scale is: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen but requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 8) Death.
• The estimated primary completion date is January 2021.
• Lenzilumab is a humanized monoclonal antibody that binds to a protein called human granulocyte macrophage-colony stimulating factor (GM-CSF) thereby potentially dampening a systemic inflammatory response.
• https://seekingalpha.com/news/3628226-dosing-underway-in-mid-stage-study-of-humanigens-lenzilumab-in-covidminus-19