KB 003 filed with FDA requesting EUA for COVID-19.- Humanigen

This EUA application follows positive results from the LIVE-AIR Phase III clinical trial evaluating the ability of lenzilumab to improve the likelihood of survival without ventilation (SWOV) in newly hospitalized COVID-19 patients.Lenzilumab achieved the primary endpoint with a 54% relative improvement in the likelihood of SWOV compared to placebo. Lenzilumab also improved the relative likelihood of SWOV by 92% in subjects who received both corticosteroids and remdesivir and resulted in a 3-fold improvement in the likelihood of SWOV in patients with a CRP<150 mg l and less than 85 years of age. in these patients, a 2.2-fold improvement in the likelihood of survival was observed with lenzilumab. no serious adverse events were attributed to lenzilumab and the overall safety profile was comparable to placebo.></150>