Data for Lilly’s bamlanivimab (LY-CoV555) in COVID-19 outpatients published in New England Journal of Medicine
INDIANAPOLIS, Oct. 28, 2020 /PRNewswire/ — The New England Journal of Medicine has published data from the monotherapy arms of BLAZE-1, a Phase 2 study assessing the efficacy and safety of Eli Lilly and Company’s (NYSE: LLY) bamlanivimab (LY-CoV555) – 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. The publication, which can be found here, follows Lilly’s proof-of-concept data announcement for bamlanivimab as monotherapy in September 2020.
“The publication of these data in a peer-reviewed journal adds to the growing body of evidence for the potential utility for neutralizing antibodies as therapeutics for people recently diagnosed with mild to moderate COVID-19, particularly high-risk patients,” said Ajay Nirula, M.D., Ph.D., vice president of immunology at Lilly and co-first author of the study. “These data show bamlanivimab may be effective in treating COVID-19 by reducing viral load, symptoms and the risk of hospitalization in outpatients.”
“It is important to treat people with COVID-19 as soon as possible after diagnosis in order to forestall development of more severe disease,” said Peter Chen, M.D., director of Pulmonary and Critical Care Medicine at Cedars-Sinai and co-first author of the study. “Our findings indicate that neutralizing antibodies may have the potential to be useful in this early-stage intervention.”
These data were submitted as part of Lilly’s request for an emergency use authorization from the U.S. Food and Drug Administration for bamlanivimab in higher-risk patients who have been recently diagnosed with mild to moderate COVID-19.
BLAZE-1 ( NCT04427501 ) is a randomized, double-blind, placebo-controlled Phase 2 study designed to assess the efficacy and safety of bamlanivimab alone or in combination with a second antibody for the treatment of symptomatic COVID-19 in the outpatient setting. To be eligible, patients were required to have mild or moderate symptoms of COVID-19 as well as a positive SARS-CoV-2 test based on a sample collected no more than three days prior to drug infusion.
The monotherapy arms of the trial enrolled mild to moderate recently diagnosed COVID-19 patients, studying three doses of bamlanivimab (700 mg, 2800 mg, and 7000 mg) versus placebo.
The primary outcome measure for the completed arms of the BLAZE-1 trial was change from baseline to day 11 in SARS-CoV-2 viral load. Additional endpoints include the percentage of participants who experience COVID-related hospitalization, ER visit or death from baseline through day 29, as well as safety.
The study is ongoing with additional treatment arms. Across all treatment arms, the trial will enroll over 800 participants.
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