BLAZE-1 phase II trial of LY CoV555 in COVID-19 published in NEJM.- Eli Lilly

The New England Journal of Medicine has published data from the monotherapy arms of BLAZE-1, a Phase II study assessing the efficacy and safety of Eli Lilly's LY CoV555 (bamlanivimab) – a neutralizing antibody – in the COVID-19 outpatient setting. This study focused on ambulatory COVID-19 patients being treated in the outpatient setting, whose symptoms did not require hospitalization at the time of enrollment. Data from the BLAZE-1 study show bamlanivimab may be effective in treating COVID-19 by reducing viral load, symptoms and the risk of hospitalization in patients recently diagnosed with mild to moderate COVID-19. In the BLAZE-1 trial, rates and types of adverse events were similar between bamlanivimab and placebo, with the majority being mild to moderate in severity and with no drug-related serious adverse events reported thus far. In other bamlanivimab studies, there have been isolated drug-related infusion reactions or hypersensitivity that were generally mild (two reported as serious infusion reactions, both patients recovered). The publication follows Lilly's proof-of-concept data announcement for bamlanivimab as monotherapy in September 2020.See: "SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19." Peter Chen et al. NEJM October 28, 2020 DOI: 10.1056/NEJMoa2029849