On Monday, Eli Lilly (LLY -1.27%) announced that it had begun a phase 3 clinical trial for Olumiant (baricitinib) as a potential treatment for COVID-19. Olumiant is already approved for the treatment of moderate to severe rheumatoid arthritis, and Eli Lilly thinks it could help prevent cytokine storms (a potentially deadly immune reaction) in patients with severe cases of COVID-19. The company also believes that Olumiant could prevent host cells from making more copies of the SARS-CoV-2 virus that causes the disease.
The pharma giant will conduct this study in the U.S. and several other countries in Europe and Latin America. Eli Lilly will enroll 400 hospitalized COVID-19 patients, each of whom will receive daily oral doses of Olumiant (or a placebo) for 14 days, or until they are released from the hospital. The primary endpoint for the trial will be the proportion of patients who die or require intensive care (in the form of mechanical ventilation) when given Olumiant as compared to those who are given a placebo.
Secondary endpoints for the study include "the proportion of patients with clinical improvement at different time points, time to recovery, duration of hospitalization, number of ventilator-free days and mortality over a 28-day period." Since Olumiant is already approved by regulatory authorities, safety issues aren't a big concern. Eli Lilly said it expects data from this study within a few months.
Eli Lilly has initiated two other clinical trials for potential COVID-19 treatments. Last week, it announced that it was starting a phase 1 study for an investigational antibody therapy called JS016. Eli Lilly is partnering with Junshi Biosciences, which will run a phase 1 trial for JS016 in China concurrently. This trial will test the safety, tolerability, immunogenicity (the ability to trigger an immune response in the body), and pharmacokinetics (the way the body processes the treatment) in healthy participants who haven't been diagnosed with COVID-19.