Eli Lilly's Neutralizing Antibody Could Significantly Reduce Risk of Contracting Symptomatic COVID-19, Finds Major Study

Bamlanivimab is authorized for emergency use by the US Food and Drug Administration for the treatment of mild to moderate COVID-19 in high-risk patients. Bamlanivimab significantly reduced the risk of contracting symptomatic COVID-19 among residents and staff of long-term care facilities, according to the Phase 3 BLAZE-2 COVID-19 prevention trial - conducted in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the COVID-19 Prevention Network (CoVPN).

The trial enrolled residents and staff at skilled nursing and assisted living facilities, commonly referred to as nursing homes, across the US. The 965 participants who tested negative for the SARS-CoV-2 virus at baseline (299 residents and 666 staff) were included in the analysis of primary and key secondary endpoints for assessing prevention, while the 132 participants (41 residents and 91 staff) who tested positive for the virus at baseline were included in exploratory analyses for assessing treatment, adding to the growing body of evidence for treatment with bamlanivimab. All participants were randomized to receive either 4,200 mg of bamlanivimab or placebo. After all participants reached 8 weeks of follow-up, there was a significantly lower frequency of symptomatic COVID-19 (the primary endpoint) in the bamlanivimab treatment arm versus placebo (odds ratio 0.43, p=0.00021). Results for all key secondary endpoints also reached statistical significance in both the overall and resident populations.

For the pre-specified subgroup of nursing home residents, there was also a significantly lower frequency of symptomatic COVID-19 in those treated with bamlanivimab versus placebo in this important population (odds ratio 0.20; p=0.00026). These results suggest that residents randomized to bamlanivimab have up to an 80% lower risk of contracting COVID-19 versus residents in the same facility randomized to placebo. Results from exploratory analyses of viral load in the treatment group were consistent with previously disclosed data from BLAZE-1 evaluating bamlanivimab as an outpatient treatment for recently diagnosed COVID-19. Among the 299 residents in the prevention group, there were four deaths attributed to COVID-19 at the time of death, and all occurred in the placebo arm. There were no COVID-19 attributed deaths in the bamlanivimab arm. Among the 41 residents in the treatment group, there were four deaths, and all occurred in the placebo arm with none in the bamlanivimab arm. Over the entire trial, there were a total of 16 deaths reported, including deaths not related to COVID-19, and all deaths were residents (11 deaths in the placebo arm and five in the bamlanivimab arm).

"We are exceptionally pleased with these positive results, which showed bamlanivimab was able to help prevent COVID-19, substantially reducing symptomatic disease among nursing home residents, some of the most vulnerable members of our society," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories. "These data provide important additional clinical evidence regarding the use of bamlanivimab to fight COVID-19 and strengthen our conviction that monoclonal antibodies such as bamlanivimab can play a critical role in turning the tide of this pandemic. We're glad bamlanivimab is already available as a treatment for patients at high risk for progressing to severe COVID-19 illness or hospitalization, including those in nursing homes, and look forward to working with regulators to explore expanding the emergency use authorization to prevent the spread of COVID-19 in these facilities."

"The results of this innovative study further support the belief that bamlanivimab – and potentially other monoclonal antibodies – can reduce symptoms and may even prevent COVID-19," said Myron S. Cohen, M.D., CoVPN co-principal investigator and director of the Institute for Global Health and Infectious Diseases at the University of North Carolina at Chapel Hill. "The antiviral activity seen with bamlanivimab treatment emphasizes the importance of early intervention to help counter the devastating impact the virus has had in this vulnerable population and other high-risk patients."


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