Eli Lilly and Co. (LLY) said Thursday that its neutralizing antibody Bamlanivimab (LY-CoV555) significantly reduced the risk of contracting symptomatic COVID-19 among residents and staff of long-term care facilities in the BLAZE-2 trial. The risk was reduced by up to 80 percent, the company noted.<\/p>\n
Bamlanivimab is authorized for emergency use by the U.S. Food and Drug Administration for the treatment of mild to moderate COVID-19 in high-risk patients.<\/p>\n
The Phase 3 BLAZE-2 COVID-19 prevention trial is being conducted by Eli Lilly in partnership with the National Institute of Allergy and Infectious Diseases or NIAID, part of the National Institutes of Health (NIH), and the COVID-19 Prevention Network (CoVPN).<\/p>\n
The trial enrolled residents and staff at skilled nursing and assisted living facilities, commonly referred to as nursing homes, across the U.S.<\/p>\n
Eli Lilly noted that the 965 participants who tested negative for the SARS-CoV-2 virus at baseline, comprising 299 residents and 666 staff, were included in the analysis of primary and key secondary endpoints for assessing prevention. <\/p>\n
The 132 participants (41 residents and 91 staff) who tested positive for the virus at baseline were included in exploratory analyses for assessing treatment.<\/p>\n
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, Eli Lilly said. <\/p>\n
Results for all key secondary endpoints also reached statistical significance in both the overall and resident populations.<\/p>\n
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.<\/p>\n
According to Eli Lilly, the results suggested that residents randomized to bamlanivimab have up to an 80 percent lower risk of contracting COVID-19 versus residents in the same facility randomized to placebo.<\/p>\n
Eli Lilly said it will present the full results from BLAZE-2 at a future medical congress and also submit for publication in a peer-reviewed clinical journal. <\/p>\n