Lilly Covid drug trial : US pharma giant launches phase 3 trial of baricitinib

Lilly Covid drug trial : Eli Lilly and Company has enrolled the first patient in a phase 3 randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of baricitinib in hospitalized adults with COVID-19.

Baricitinib is an oral JAK1/JAK2 inhibitor, which was licensed by Lilly from Incyte. Marketed as OLUMIANT, baricitinib has approval in 70 countries as a treatment for moderately to severely active rheumatoid arthritis in adults.

The Lilly Covid drug trial is anticipated to feature 400 patients with data likely to be released in the next few months. The Covid clinical trial will be held in the US, Europe, and Latin America.

The coronavirus trial will include people hospitalized with SARS-CoV-2 infection who have at least one elevated marker of inflammation but do not need invasive mechanical ventilation at study entry.

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The primary endpoint of the Lilly Covid drug trial is the proportion of patients who die or need non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation by Day 28 in patients subjected to 4mg of baricitinib daily (with background therapy) compared to placebo (with background therapy).

Key secondary outcomes of the coronavirus clinical trial include the proportion of patients with clinical improvement at different time points, time taken for recovery, hospitalization duration, number of ventilator-free days, and mortality over a 28-day period.

Commenting on the Lilly Covid drug trial, Patrik Jonsson – Lilly senior vice president and president of Lilly Bio-Medicines said: “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.

“This randomized controlled study is an important step in our understanding of baricitinib as a potential COVID-19 treatment.”