Eli Lilly and Company (NYSE: LLY) today announced new data from the randomized, double-blind, placebo-controlled BLAZE-1 Phase 3 study, demonstrating bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together significantly reduced COVID-19 related hospitalizations and deaths (“events”) in high-risk patients recently diagnosed with COVID-19. These results provide additional efficacy and safety data that support the use of the dose recently granted both Emergency Use Authorization by the U.S. Food and Drug Administration (FDA) and a positive scientific opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
This new Phase 3 cohort of BLAZE-1 included 769 high-risk patients, aged 12 and older with mild to moderate COVID-19 (therapy: n=511; placebo: n=258). There were four events in patients taking bamlanivimab with etesevimab and 15 events in patients taking placebo, representing an 87 percent risk reduction (p<0.0001). Bamlanivimab and etesevimab together also demonstrated statistically significant improvements on key secondary endpoints. These results are consistent with those seen in other data sets from BLAZE-1: in the previous Phase 3 cohort, bamlanivimab 2800 mg with etesevimab 2800 mg reduced the risk of hospitalizations and deaths by 70 percent and in the Phase 2 cohort, bamlanivimab alone reduced the risk of hospitalizations and ER visits by approximately 70 percent. The viral load reductions were also consistent with what was observed in the previous Phase 3 cohort of the study.
In this new Phase 3 cohort, there were four deaths total, all of which were deemed related to COVID-19 and all of which occurred in patients taking placebo; no deaths occurred in patients receiving treatment with bamlanivimab and etesevimab together. Across the two Phase 3 cohorts of the study that have been analyzed to date, there have been no deaths in patients receiving treatment with bamlanivimab and etesevimab together, and 14 deaths in patients receiving placebo, 13 of which were deemed COVID-19 related. In this data set, the safety profile of bamlanivimab and etesevimab together was consistent with observations from other Phase 1, Phase 2 and Phase 3 trials evaluating these antibodies…..view full release here