Humanigen says NIH launches ACTIV-5 'Big Effect Trial' on lenzilumab as potential COVID-19 therapy

Humanigen Inc (NASDAQ:HGEN) said Tuesday that its potential coronavirus treatment lenzilumab has been selected for the ACTIV-5 “Big Effect Trial,” 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 at as many as 40 US sites and will evaluate lenzilumab with remdesivir, compared to placebo and remdesivir, in hospitalized COVID-19 patients with approximately 100 patients assigned to each study arm. Humanigen is providing lenzilumab for the study, which is fully funded by NIH. Burlingame, California-based Humanigen is focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate lenzilumab. READ: Humanigen gets positive feedback from FDA ahead of emergency use application for coronavirus drug lenzilumab “Lenzilumab is one of the few Phase 3 treatment options in development for COVID-19, and we believe that its mechanism of action as an immunomodulator could work very nicely with remdesivir and potentially enhance first line standard of care therapy to prevent serious and potentially fatal outcomes,” Humanigen CEO Cameron Durrant said in a statement. “We are excited at NIH’s recognition of the potential of our drug candidate for this new ACTIV trial, reinforcing the importance of testing and funding for therapeutics to treat COVID-19, and we are eager to put lenzilumab through further rigorous testing to contribute to the battle against this pandemic.” ACTIV-5/BET is being conducted with the NIH’s public-private partnership program — Accelerating COVID-19 Therapeutic Innovations and Vaccines (ACTIV). It has evaluated around 400 therapeutic agents and developed a collaborative framework for prioritizing the most promising candidates, streamlining clinical trials, regulatory processes, and leveraging assets to battle COVID-19 and future pandemics. “To date, ACTIV has designed five adaptive master protocols for ACTIV clinical trials, and selected numerous NIH-supported networks to launch these clinical trials to test prioritized therapeutic candidates,” noted Humanigen. Contact the author Uttara Choudhury at uttara@proactiveinvestors.com Follow her on Twitter: @UttaraProactive