A combination of two Eli Lilly antibody products was found to reduce the risk of hospitalization and death in high-risk patients recently diagnosed with a coronavirus by 70%, the company said Tuesday. The results stem from a Phase 3 BLAZE-1 trial involving 1,035 patients, adding to previous data collected during Phase 2 trials.
In the trial, patients were given 2800 mg bamlanivimab and 2800 mg etesevimab. Among the group receiving the combination therapy, there were 11 “events”, such as hospitalizations, compared to 36 “events” recorded in the placebo group, indicating a 70% reduction in risk. There were ten deaths during the trial, but the patients involved in the placebo group were, according to the company.
“These exciting results, which replicate positive Phase 2 data in a much larger set of patients, provide valuable clinical evidence on the role that neutralizing antibodies may play in combating this pandemic. While the preliminary nature of Phase 2 is due to COVID-19 that neutralizes monoclonal antibodies may have limited acceptance of the treatment, this Phase 3 data further reinforces the available evidence, ‘said Daniel Skovronsky, MD, Ph.D., Lilly’s Chief Scientific Officer and President of Lilly Research Laboratories, said in a news release on Tuesday.
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Skovronsky said the data builds on the results of a phase 2 trial that includes only bamlanivimab, which also had a decrease in ER visits and hospitalization in coronavirus patients. The company also has an ongoing BLAZE-4 study examining the effectiveness of giving lower doses of combination therapy to patients to maximize supply and reduce infusion times.
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The FDA only approved bamlanivimab emergency use in early November for the treatment of mild to moderate COVID-19 in adult and pediatric patients older than 12. At that time, studies showed that the drug COVID-19-related hospitalizations and ER- visits reduced. in patients.
The FDA has not yet approved the combination therapy, but the company is hopeful it can help tame the rising hospitalization rates as the country waits to see the impact of the vaccine vaccination.