Eli Lilly will assess its JAK1/JAK2 inhibitor Olumiant (baricitinib) as a potential treatment for COVID-19 in a Phase III study.
Indianapolis-based Eli Lilly said the latest study will complement an ongoing study of the rheumatoid arthritis drug being conducted in partnership with the National Institute of Allergy and Infectious Diseases (NIAID). This morning, Lilly said it intends to enroll approximately 400 patients in the double-blind, placebo-controlled study that will include patients hospitalized with SARS-CoV-2 infection who have at least one elevated marker of inflammation but do not require invasive mechanical ventilation at study entry.
The primary endpoint for Lilly’s new study is the proportion of patients who die or require non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation following 28 days of daily treatment with 4 mg of baricitinib. Key secondary outcomes of this 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.
Olumiant isn’t the first rheumatoid arthritis drug being aimed at the disease. Other drugs that inhibit Interleukin-6, such as Roche’s Actemra and Regeneron and Sanofi’s Kevzara, are also being studied as a potential treatment for the cytokine storms associated with the disease. Unlike Actemra, Olumiant is a JAK-inhibitor. Kevzara hit a snag in April during an ongoing study in COVID-19 and amended protocols as it continued. It’s thought that inhibition of JAK 1 and JAK 2 may also play a role in reducing the cytokine storm associated with the most severe complications of COVID-19. In addition, Eli Lilly suspects Olumiant may have a role in inhibiting the host cell proteins that assist in viral reproduction, reducing the ability of infected cells to make more of the virus. Studying baricitinib in controlled trials is important in order to better characterize its potential benefits and understand the safety of its use as a COVID-19 treatment, the company added.
Patrik Jonsson, president of Lilly Bio-Medicines, said the Phase III study in this indication is an important step in the company’s understanding of baricitinib as a potential COVID-19 treatment. He said Lilly is committed to fighting the global pandemic, which includes studying the efficacy of older medications against the disease that has infected nearly 8 million people across the globe, including more than 2 million in the United States.
Data from this Phase III study will complement the NIAID study, which is also assessing Olumiant in combination with Gilead Science’s remdesivir, which previously received Emergency Use Authorization from the U.S. Food and Drug Administration against COVID-19.
In addition to Olumiant, Eli Lilly partnered with Vancouver-based AbCellera to co-develop antibody products against the disease. Also, Eli Lilly partnered with the state of Indiana to accelerate testing for the virus in that state.