The ACTIV-3 phase III study testing Eli Lilly and Co.’s COVID-19 antibody candidate, LY-CoV555, which was paused two weeks ago following a participant’s unexplained illness, has now been halted, the company reported Oct. 26, based on a review of trial data suggesting the drug, also known as bamlanivimab, is unlikely to help hospitalized patients recover from an advanced stage of the disease.
ACTIV-3, being run by the U.S. NIH’s National Institute of Allergy and Infectious Diseases, was the only study testing bamlanivimab in hospitalized patients. It was designed to evaluate Lilly’s drug alongside Veklury (remdesivir, Gilead Sciences Inc.). Lilly previously acknowledged that its antibody might have less benefit in that population, given the severe level of disease.
Ongoing studies testing bamlanivimab in other COVID-19 populations remain unchanged. The phase II BLAZE-1 study is testing the drug as a monotherapy and in combination with another Lilly drug, LY-CoV016, in ambulatory care settings. Based on data from that trial, the company recently submitted a request to the FDA seeking emergency use authorization for the combo in recently diagnosed mild to moderate COVID-19 in high-risk patients.
Also ongoing are the phase III BLAZE-2 trial, evaluating the potential of bamlanivimab to prevent COVID-19 in residents and staff at long-term care facilities, and ACTIV-2, another NIH-sponsored study, which continues to test bamlanivimab in recently diagnosed COVID-19 patients with mild to moderate cases of the disease.