Lilly enrols first COVID-19 patient in Phase III study to test baricitinib

Eli Lilly and Company have announced that the first patient has been enrolled in a Phase III study to evaluate the efficacy and safety of baricitinib, an oral JAK1/JAK2 inhibitor licensed from Incyte, in hospitalised adults with COVID-19.

The trial will be a randomised, double-blind, placebo-controlled study. Lilly expects to enrol 400  patients in total, with data expected in the next few months. The study will be conducted in the US, Europe and Latin America and includes patients hospitalised with SARS-CoV-2 infection who have at least one elevated marker of inflammation but do not require invasive mechanical ventilation at study entry. Patients will receive baricitinib or placebo for up to 14 days or until discharge from the hospital. 

The company says it is hypothesised that through JAK1 and JAK2 inhibition, baricitinib may reduce the cytokine storm associated with the complications of COVID-19 infection. In addition, the drug 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 4mg of baricitinib daily (with background therapy) compared to placebo (with background therapy).

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

Should research efforts for the drug in COVID-19 prove successful, Lilly says it will continue to create adequate supply to support both appropriate clinical and investigational use.

According to Lilly, baricitinib is currently approved in 70 countries as a treatment for adults with moderately to severely active rheumatoid arthritis.