Eli Lilly Announces Phase 3 Clinical Trial of Baricitinib for COVID-19 Patients

A phase 3 clinical trial kicked off today to assess the effectiveness of Eli Lilly and Company’s rheumatoid arthritis (RA) drug baricitinib, marketed as Olumiant®, in hospitalized COVID-19 patients, the company announced.

Lilly expects to enroll about 400 patients in the U.S., Europe, and Latin America in the study, which started dosing participants last week. COVID-19 patients with at least one elevated marker of inflammation but do not require invasive medical ventilation at baseline are eligible for inclusion.

Increased COVID-19 severity may be correlated with a hyperinflammatory state in some patients. Lilly hopes that baricitinib will lower the “cytokine storm” associated with the virus. The cytokine storm refers to COVID-19 patients who appear to be getting better, then rapidly deteriorate. This happens when the body is no longer fighting off the virus but instead starts attacking its own immune system. Cytokine storms are seen in patients with rheumatic diseases as well as cancer.

Baricitinib is currently approved for active RA patients in 70 countries.

In the phase 3 baricitinib study, patients will receive either baricitinib 4 mg daily plus background therapy or placebo plus background therapy for up to 14 days, or until they are discharged from the hospital. The main endpoint is the proportion of patients who die or are placed on non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation by day 28. Additional outcomes will include the proportion of patients with clinical improvements at different time points, time to recovery, length of hospital stay, number of ventilator-free days, and mortality over 28 days.

The drug could receive U.S. regulatory approval by August, Patrik Jonsson, Lilly senior vice president and president of Lilly Bio-Medicines, reportedly told Reuters.

Meanwhile, Eli Lilly is also working on phase II of the Adaptive COVID-19 Treatment Trial. This study, an effort of the National Institute of Allergy and Infectious Diseases, enrolled its first patient last month and is comparing the efficacy of combination 4 mg baricitinib plus remdesivir versus remdesivir alone. Gilead’s remdesivir was granted emergency use authorization from the Food and Drug Administration last month. According to Jonsson, the combination treatment may be approved by July, according to the Reuters report.