Eli Lilly: Phase 3 BLAZE-1 Trial Meets Primary And Secondary Endpoints
Eli Lilly and Co. (LLY) said Tuesday that the Phase 3 BLAZE-1 trial met primary endpoint and key secondary endpoints with high statistical significance.
According to the company, its neutralizing antibodies Bamlanivimab (LY-CoV555) 2800 mg and etesevimab (LY-CoV016) 2800 mg together reduced COVID-19-related hospitalizations and deaths in high-risk patients recently diagnosed with COVID-19 by 70 percent, and met the primary endpoint of the Phase 3 BLAZE-1 trial.
Across 1,035 patients, there were 11 events in patients taking therapy and 36 events in patients taking placebo, representing a 70 percent risk reduction. There were 10 deaths total, all of which occurred in patients taking placebo, and no deaths in patients taking bamlanivimab and etesevimab together, Lilly said.
Bamlanivimab and etesevimab together also demonstrated statistically significant improvements on all key secondary endpoints, providing strong evidence that the therapy reduced viral load and accelerated symptom resolution.
“Notably, the 70 percent decrease in risk of hospitalizations or death seen in this Phase 3 trial of bamlanivimab and etesevimab together is consistent with the reduction in risk of hospitalization or ER visits seen with bamlanivimab alone in the Phase 2 trial. Bamlanivimab alone is authorized for emergency use as a treatment for high-risk patients with mild to moderate COVID-19 in the U.S. and widely available for use,” said Daniel Skovronsky, Lilly’s chief scientific officer and president of Lilly Research Laboratories
In the trial, 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. Serious adverse events were reported at a similar frequency in the bamlanivimab and etesevimab together and placebo groups, Lilly noted.
Further, Lilly said that initial results from the ongoing BLAZE-4 trial provide viral load and pharmacodynamic/pharmacokinetic data which demonstrated lower doses, including bamlanivimab 700 mg and etesevimab 1400 mg together, are similar to bamlanivimab 2800 mg and etesevimab 2800 mg together.
Lilly plans to explore even lower doses of bamlanivimab and etesevimab together, as lower doses can maximize available supply to treat more patients, allow potential for subcutaneous dosing, and potentially reduce the burden on the healthcare system and patients through reduced infusion times.
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