Eli Lilly and Co. has entered into an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), to study baricitinib as an arm in NIAID’s Adaptive COVID-19 Treatment Trial. The study will evaluate safety and efficacy of baricitinib as a potential treatment for hospitalized patients with COVID-19, beginning this month in the U.S. with a planned expansion to additional sites. Results are expected within the next two months.

Baricitinib, an oral JAK1/JAK2 inhibitor marketed as OLUMIANT, is approved in more than 65 countries as a treatment for adults with moderately to severely active rheumatoid arthritis. Given the inflammatory cascade seen in COVID-19, baricitinib’s anti-inflammatory activity has been hypothesized to have a potential benefit in COVID-19 and warrants further study in patients with this infection.

Lilly is also advancing LY3127804, an investigational selective monoclonal antibody against Angiopoietin 2 (Ang2), to Phase II testing in pneumonia patients hospitalized with COVID-19 who are at a higher risk of progressing to acute respiratory distress syndrome (ARDS). Ang2 is known to be elevated in ARDS patients and Lilly will test whether inhibiting the effects of Ang2 with a monoclonal antibody can reduce the progression to ARDS or the need for mechanical ventilation in COVID-19 patients. This trial will begin later this month at several U.S. centers.  

Lilly currently does not anticipate shortages for any of its medicines, including baricitinib, which remains widely available in countries where it is approved. Should research efforts for baricitinib in COVID-19 prove successful, Lilly will continue to create adequate supply to support both appropriate clinical and investigational use.