AbCellera-Discovered Bamlanivimab Together with Etesevimab Reduced Hospitalizations and Prevented Death in Phase 3 Trial for Early COVID-19
Patients who received bamlanivimab and etesevimab together had an 87% reduction in hospitalizations and death; no patients died who received the therapy
VANCOUVER, British Columbia -- AbCellera (Nasdaq: ABCL) today announced that bamlanivimab (LY-CoV555) 700 mg, a human antibody discovered by AbCellera and developed with Eli Lilly and Company (Lilly), and etesevimab 1400 mg (LY-CoV16) together reduced COVID-19-related hospitalizations and deaths by 87% in high-risk patients recently diagnosed with COVID-19. These results mark the second positive Phase 3 trial readout for bamlanivimab and etesevimab together, adding to the growing safety and efficacy data that has resulted in the following key milestones accelerating the adoption of the antibody therapy globally:
- Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA).
- Expanded access in the European Union through the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
- Recommended use by the National Institutes of Health through its COVID-19 Treatment Guidelines.
- Delivery of up to 1.2 million doses to the U.S. government through a purchase agreement with Lilly.
“Across the two Phase 3 cohorts of the BLAZE-1 study, there were no deaths in patients who received bamlanivimab together with etesevimab, as compared to 14 deaths in patients receiving placebo, 13 of which were categorized as COVID-19-related,” said Carl Hansen, Ph.D., CEO and President of AbCellera. “No COVID-19-related deaths have been observed across the thousands of patients who have been treated with bamlanivimab alone or together with etesevimab in clinical trials. These antibody therapies can be powerful tools in keeping COVID-19 patients out of the hospital and preventing death.”
The results from this new randomized, double-blind, placebo-controlled Phase 3 BLAZE-1 study provide additional efficacy and safety data that support the use of the dose recently granted both EUA by the U.S. FDA, and a positive scientific opinion by the EMA CHMP.
Key details from the study, which included 769 high-risk patients, aged 12 and older with mild to moderate COVID-19 (therapy: n=511; placebo: n=258), are as follows:
- 87% reduction in COVID-19-related hospitalizations and deaths versus placebo (p<0.0001).
- No COVID-19-related deaths in the treatment group. All deaths occurred in patients treated with the placebo.
- A safety profile consistent with those observed from other Phase 1, Phase 2, and Phase 3 trials evaluating these antibodies.
Details regarding Lilly’s BLAZE-1 trial can be found here.
Bamlanivimab alone and together with etesevimab are authorized under special/emergency pathways, in the context of the pandemic, in the U.S. and the European Union. In addition, bamlanivimab alone is authorized for emergency use in Canada, Panama, Kuwait, the UAE, Israel, Rwanda, Morocco and numerous other countries. Through Lilly’s work with the Bill & Melinda Gates Foundation, Lilly is providing doses of bamlanivimab free of charge in Rwanda and Morocco.