Lilly begins phase III trial for COVID-19 therapy

By The Science Advisory Board staff writers

June 15, 2020 -- Eli Lilly has enrolled patients in a phase III study to evaluate the efficacy and safety of baricitinib in hospitalized adults with COVID-19.

Baricitinib, marketed by the company as Olumiant, is an oral Janus kinase (JAK)1/JAK2 inhibitor licensed from Incyte that has been approved in 70 countries as a treatment for rheumatoid arthritis.

COVID-19 can be associated with a hyperinflammatory state and JAK1/JAK2 inhibition may reduce the cytokine storm caused by SARS-CoV-2 infection. In addition to being a JAK1/JAK2 inhibitor, baricitinib may also inhibit cell host proteins that assist in viral reproduction, thereby reducing the ability of infected cells to produce more virus.

Lilly expects to enroll 400 patients in the randomized, double-blind, placebo-controlled study. The study will be conducted in the U.S., Europe, and Latin America and will include patients hospitalized with SARS-CoV-2 infection who have at least one elevated marker of inflammation but who do not require invasive mechanical ventilation. Patients will be dosed with 4 milligrams of baricitinib daily or placebo for up to 14 days or until discharge.

Upon successful approval for use of baricitinib in COVID-19, Lilly will continue to create adequate supply to support both appropriate clinical and investigational use.

This study will complement data from a study of baricitinib with remdesivir in the second phase of the Adaptive COVID-19 Treatment Trial (ACTT-2) run by the National Institute of Allergy and Infectious Diseases, part of the U.S. National Institutes of Health.

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