Eli Lilly Begins Phase 3 Trial to Study Potential of Rheumatoid Arthritis Drug as COVID-19 Treatment

Eli Lilly and Company (Indianapolis, Ind, USA) has enrolled the first patient in a Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of baricitinib, an oral JAK1/JAK2 inhibitor, in hospitalized adults with COVID-19.

Baricitinib, a product licensed to Eli Lilly by Incyte and marketed under the brand name Olumiant, is approved in the US and in more than 65 additional countries as a treatment for adults with moderately to severely active rheumatoid arthritis. Some people with COVID-19 experience acute respiratory distress syndrome (ARDS), in which inflammation of the lungs leads to shortness of breath and rapid breathing. It is hypothesized that through JAK1 and JAK2 inhibition, baricitinib may reduce the cytokine storm associated with the complications of this infection. In addition, baricitinib may have a role in inhibiting the host cell proteins that assist in viral reproduction, reducing the ability of infected cells to make more virus.

The primary endpoint for Lilly's study is the proportion of patients who die or require non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation by Day 28 in patients treated with 4 mg of baricitinib daily (with background therapy) compared to placebo (with background therapy). Patients will receive baricitinib or placebo for up to 14 days or until discharge from the hospital. 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. Lilly expects to enroll 400 patients in the trial, with data expected in the next few months. The study will be conducted in the US, Europe and Latin America and includes 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 data from Lilly's trial will complement data from the 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 (NIAID), part of the National Institutes of Health (NIH). This study, which enrolled its first patient last month, assesses the efficacy and safety of the combination of a 4-mg daily dose of baricitinib plus remdesivir, as compared to remdesivir.

"Lilly is committed to fighting this global pandemic, and this includes testing whether existing medicines including baricitinib could help treat the complications of COVID-19 in patients," said Patrik Jonsson, Lilly senior vice president and president of Lilly Bio-Medicines. "This randomized controlled study is an important step in our understanding of baricitinib as a potential COVID-19 treatment."

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