Eli Lilly and Company is set to start a new pragmatic study of its Covid-19 treatment candidate, bamlanivimab (LY-CoV555) in high-risk patients with Covid-19, along with major institutions in the state of New Mexico, US.
Developed by Lilly and AbCellera, bamlanivimab is a recombinant, neutralising human IgG1 monoclonal antibody directed against the spike protein of SARS-CoV-2.
Recently, the US Food and Drug Administration (FDA) granted Emergency Use Authorisation (EUA) for bamlanivimab 700mg injection to treat mild to moderate Covid-19.
Adult patients and paediatric patients aged 12 years or above, who are at high risk of progressing to severe disease and/or hospitalisation, are authorised to use the vaccine.
The study in New Mexico will help in collecting data on the effectiveness and safety of bamlanivimab in a real-world setting with a diverse population and includes both rural and urban environments.
Lilly chief scientific officer and Lilly Research Laboratories president Daniel Skovronsky said: “It is important to continue building on the evidence base for bamlanivimab through ongoing studies, including those in a real-world setting.
“In addition to gathering treatment and safety data, Lilly will use this study to explore the delivery of bamlanivimab in a variety of innovative infusion settings, which could help inform best practices and ultimately replication by institutions around the country.”
Set to begin in the coming weeks, the study will analyse the effectiveness of bamlanivimab in reducing Covid-19 hospitalisations in a high-risk group.
As per the study design, various infusion settings will be used across the state, allowing access to several diverse communities which include Native American communities.
Lilly will use its mobile research units which have a custom retrofitted recreational vehicle (RV) solution to support mobile labs and clinical trial material preparation.
In September, Lilly reported positive proof-of-concept results from the BLAZE-1 clinical trial, which assessed SARS-CoV-2 neutralising antibody candidate LY-CoV555, to treat symptomatic Covid-19 in outpatients.