Humanigen says first patient dosed in NIH-run ACTIV-5 ‘Big Effect Trial’ evaluating lenzilumab for COVID-19

Humanigen Inc (NASDAQ:HGEN) (FRA:0KB2) revealed on Thursday that the first patient has been dosed at the Emory University School of Medicine in Atlanta as part of the ACTIV-5 “Big Effect Trial,” evaluating the firm’s potential coronavirus (COVID-19) treatment lenzilumab with remdesivir, compared to placebo and remdesivir in patients hospitalized with COVID-19.  Burlingame, California-based Humanigen is focused on preventing and treating an immune hyper-response called ‘cytokine storm’ in COVID-19 patients with its lead drug candidate lenzilumab.  The ACTIV-5 “Big Effect Trial” is being run by the National Institute of Allergy and Infectious Diseases (NIAID) to evaluate whether some promising investigational drugs should be advanced into larger clinical trials for battling COVID-19. NIAID, which is part of the US National Institutes of Health (NIH), will enroll as many as 40 US sites and will evaluate lenzilumab with remdesivir, compared to placebo and remdesivir, in hospitalized COVID-19 patients with around 200 patients assigned to each study arm. There will be about 100 patients assigned to each study arm. READ: Humanigen says NIH launches ACTIV-5 'Big Effect Trial' on lenzilumab as potential COVID-19 therapy “Nearly 90% of hospitalized COVID-19 patients progress to severe disease, including the cytokine storm for some patients,” said Vincent C Marconi, Professor of Medicine and Global Health in Emory University School of Medicine and Emory’s Rollins School of Public Health. “There is a critical need for a novel COVID-19 therapeutic with potential to reduce patients’ time to recovery, and this study aims to streamline the pathway to finding these urgently needed treatments,” he added. Humanigen is providing lenzilumab for the study, which is fully funded by NIH. “We are encouraged by lenzilumab’s efficacy and safety data demonstrated in hospitalized COVID-19 patients to date and believe we have a game-changing treatment with frontline potential,” said Humanigen CEO Cameron Durrant. “We are eager to put lenzilumab through further rigorous testing in this NIH ACTIV-5 study as we continue to advance our lead candidate in the next phases of development.” More details on Humanigen’s programs in COVID-19 can be found on the company’s website. Contact the author Uttara Choudhury at uttara@proactiveinvestors.com Follow her on Twitter: @UttaraProactive