Indianapolis-based Eli Lilly and Co. (NYSE: LLY) will start a new pragmatic study of bamlanivimab in high-risk COVID-19 patients in New Mexico. Lilly says performing the study in New Mexico will allow for data collection on the effectiveness and safety of the drug in diverse, rural and urban populations.
Bamlanivimab recently received Emergency Use Authorization by the U.S. Food and Drug Administration for treating mild to moderate COVID-19 in high-risk patients.
“It is important to continue building on the evidence base for bamlanivimab through ongoing studies, including those in a real-world setting,” said Daniel Skovronsky, M.D., Ph.D., Lilly’s chief scientific officer and president of Lilly Research Laboratories. “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.”
Lilly says the study will begin in a few weeks and will test the effectiveness of the drug in reducing hospitalizations relating to COVID-19. Lilly will use its mobile research units, including custom RV’s and support vehicles, to deliver the clinical trial supplies to an infusion clinic for patients.
Lilly has completed a Phase 1 study of the drug in hospitalized COVID-19 patients, and a Phase 2 study of people recently diagnosed with COVID is ongoing.