New data from the BLAZE-1 clinical trial showed that treatment with 2 of Lilly’s severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing antibodies (bamlanivimab [LY-CoV555] plus etesevimab [LY-CoV016]) reduced viral load as well as symptoms, hospitalizations and emergency room (ER) visits among patients with coronavirus disease 2019 (COVID-19).
An interim analysis of the phase 2 study evaluated the combination therapy in recently diagnosed patients with mild to moderate COVID-19. Patients were randomized to receive 2800mg of each antibody (n=112) or placebo (n=156). The primary end point of the study was change from baseline to day 11 in SARS-CoV-2 viral load; additional end points included the percentage of patients who experienced COVID-related hospitalization, ER visits or death from baseline through day 29.
Results showed that the combination therapy significantly reduced viral load (P =.011), with most patients demonstrating near complete viral clearance by day 11. Additionally, the antibody treatment was associated with reduced viral levels at both days 3 (P =.016) and 7 (P <.001).
Symptom improvement in the combination therapy group was observed as early as day 3. Moreover, the rate of hospitalization and ER visits was found to be lower in the combination therapy arm (0.9%) compared with the placebo arm (5.8%), corresponding to a relative risk reduction of 84.5% (P = .049); the Company noted these findings were similar to those in the bamlanivimab monotherapy arm of the study. As for safety, the combination therapy was generally well tolerated with no serious adverse events reported.
“We believe the data generated to date provide sufficient evidence that both monotherapy and combination therapy may be effective to treat COVID-19 in patients with a high risk for serious outcomes,” said Daniel Skovronsky, MD, PhD, Lilly’s chief scientific officer and president of Lilly Research Laboratories.
Based on data from both study arms, Lilly has submitted an initial request for emergency use authorization (EUA) for bamlanivimab monotherapy in higher-risk patients who have been recently diagnosed with mild to moderate COVID-19. According to the Company, an EUA request for the combination treatment is expected to be submitted sometime in November and a Biologics License Application potentially by the second quarter of 2021.
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Lilly provides comprehensive update on progress of SARS-CoV-2 neutralizing antibody programs. [press release]. Indianapolis, IN: Lilly; October 7, 2020.