Eli Lilly and Company has announced results from the Phase III BLAZE-2 trial, which showed bamlanivimab (LY-CoV555) significantly lowered the risk of contracting symptomatic Covid-19 in nursing homes’ residents and staff.
Developed by Lilly and AbCellera, bamlanivimab is a recombinant, neutralising human IgG1 monoclonal antibody (mAb) directed against SARS-CoV-2 spike protein.
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The ongoing trial is carried out in collaboration with the National Institutes of Health (NIH) unit the National Institute of Allergy and Infectious Diseases (NIAID) and the COVID-19 Prevention Network (CoVPN).
It is a randomised, double-blind, placebo-controlled trial to analyse the efficacy and safety of bamlanivimab 4200mg versus placebo in preventing Covid-19 in skilled nursing and assisted living facility (nursing home) residents and staff.
The 965 Covid-19 negative subjects (299 residents and 666 staff) were included in the analysis of primary and key secondary endpoints for evaluating prevention, while 132 Covid-19-positive participants (41 residents and 91 staff) were part of the exploratory analyses for analysing treatment.
Data showed that after eight weeks of follow-up, significantly lower frequency of symptomatic Covid-19 (the primary endpoint) was observed in the treatment arm as compared with placebo.
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By GlobalDataResults for all key secondary endpoints also reached statistical significance in both populations.
Nursing home residents who received bamlanivimab were shown to have up to an 80% reduced risk of contracting Covid-19 versus residents in the placebo arm.
Exploratory analyses results of viral load in the treatment group were consistent with previously observed data from BLAZE-1 study in the outpatient setting.
A total of 11 deaths of residents were reported, including deaths not related to Covid-19 in the placebo group versus five in bamlanivimab group.
Lilly chief scientific officer and Lilly Research Laboratories president Daniel Skovronsky said: “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.”
