A combination of two Eli Lilly antibody drugs has been found to reduce the risk of hospitalization and death in high-risk patients recently diagnosed with coronavirus by 70%, the company said on Tuesday. The results result from a Phase 3 BLAZE-1 study involving 1,035 patients and add to the previous data collected during Phase 2 studies.
The study looked at patients who received 2,800 mg of bamlanivimab and 2,800 mg of etesevimab. Among the group receiving the combination therapy, there were 11 “events”, such as hospitalizations, against 36 “events” recorded in the placebo group, marking a 70% reduction in risk. There were 10 deaths during the trial, but all involved patients in the placebo group, the company said.
“These exciting results, which replicate the positive Phase 2 data in a much larger group of patients, add valuable clinical evidence about the role that neutralizing antibodies can play in fighting this pandemic. While the preliminary nature of Phase 2 results from the antibodies COVID-19 neutralizing monoclonal antibodies may have limited treatment acceptance, this Phase 3 data further strengthens the available evidence, “said Daniel Skovronsky, MD, Ph.D., Lilly’s scientific director and president of Lilly Research Laboratories, in a statement published on Tuesday.
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Skovronsky said the data is based on the results of a Phase 2 study involving only bamlanivimab, which also saw a reduction in emergency room visits and hospitalization in patients with coronavirus. The company also has an ongoing BLAZE-4 study exploring the effectiveness of administering lower doses of combination therapy to patients to maximize delivery and reduce infusion times.
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The FDA first granted emergency use authorization for bamlanivimab in early November to treat mild to moderate COVID-19 in adult and pediatric patients over 12 years of age. At that time, trials showed that the drug reduced COVID-19-related hospitalizations and emergency patient visits.
Combination therapy has not yet been authorized by the FDA, but the company hopes it can help tame rising hospitalization rates, while the country waits to see the impact of the vaccine’s launch.