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A combination of two anti-Eli Lilly antibodies has reduced the risk of hospitalization and death by 70% in high-risk patients recently diagnosed with coronavirus, the company said on Tuesday. The results are from a Phase 3 BLAZE-1 trial involving 1,035 patients and are in addition to previous data collected during the Phase 2 trials.
The trial saw patients receiving 2800 mg of bamlanivimab and 2800 mg of etesevimab. In the group that received the combination therapy, there were 11 “events”, such as hospitalizations, compared to 36 “events” recorded in the placebo group, marking a 70% reduction in risk. There were 10 deaths that occurred during the trial, but all of them involved patients in the placebo group, the company said.
“These exciting results, which replicate positive Phase 2 data in more patients, add valuable clinical evidence on the role that neutralizing antibodies can play in the fight against this pandemic. While the preliminary nature of Phase 2 results from 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., director Lilly scientist and president of Lilly Research Laboratories, in a statement released Tuesday.
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Skovronsky said the data is based on the results of a Phase 2 trial involving only bamlanivimab which also saw a reduction in emergency room visits and hospitalizations in patients with coronavirus. The company also has an ongoing BLAZE-4 trial exploring the effectiveness of delivering lower doses of the combination therapy to patients to potentially maximize supply 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. in patients.
The combination therapy has not yet been approved by the FDA, but the company is hoping it could help tame skyrocketing hospitalization rates as the country waits to see the impact of the vaccine rollout.
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