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.
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.
Results 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.”