Phase III BLAZE-1 trial of LY CoV555 and LY CoV016 meets primary endpoint in COVID-19.- Eli Lilly

Eli Lilly announced that LY CoV555 (bamlanivimab) 2800 mg and LY CoV016 (etesevimab) 2800 mg together significantly reduced COVID-19-related hospitalizations and deaths in high-risk patients recently diagnosed with COVID-19, meeting the primary endpoint of the Phase III BLAZE-1 trial. Across 1,035 patients, there were 11 events (2.1 percent) in patients taking therapy and 36 events (7.0 percent) in patients taking placebo, representing a 70 percent risk reduction (p= 0.0004). There were 10 deaths total, all of which occurred in patients taking placebo, and no deaths in patients taking bamlanivimab and etesevimab together. 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. In the trial, the safety profile of bamlanivimab and etesevimab together was consistent with observations from other Phase I, Phase II and Phase III trials evaluating these antibodies. Serious adverse events were reported at a similar frequency in the bamlanivimab and etesevimab together and placebo groups. Across multiple clinical trials, Lilly has collected safety and efficacy data in more than 4,000 participants treated with Lilly's neutralizing antibodies, either bamlanivimab alone or bamlanivimab and etesevimab together. Additionally, 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.