Lilly starts phase 3 trial of baricitinib in COVID-19

Eli Lilly has begun enrolment for a phase 3 study of its JAK inhibitor baricitinib in hospitalised adults with COVID-19.

Lilly has revealed that it plans to enrol 400 participants into the pivotal trial, and expects to have data for the drug in COVID-19 within the next few months.

The study is set to take place in the US, Europe and Latin America and includes patients hospitalised with SARS-CoV-2 infection, which causes COVID-19, who have at least one elevated marker of inflammation but do not require invasive mechanical ventilation. Participants will receive baricitinib or placebo for up to 14 days or until discharge from hospital.

Baricitinib is already approved, under the brand name Olumiant, in 70 countries as a treatment for adults with moderately to severe active rheumatoid arthritis. It works by inhibiting certain JAK enzymes, which have been implicated in a number of inflammatory and autoimmune diseases.

Among patients infected with COVID-19, a hyper inflammatory state can be associated with increased disease severity. Lilly hopes that baricitinib may be able to reduce cytokine storm, an overactive inflammatory response, associated with complications of COVID-19 infection.

"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,” he added.

Other anti-inflammatory drugs have proved effective against COVID-19, including Roche’s interleukin-6 inhibitor Actemra (tocilizumab). Actemra has already been approved in China for the treatment of COVID-19 patients with lung complications and elevated levels of IL-6.

Prior research has suggested that elevated levels of IL-6 – a biomarker for inflammation and a high-level immune response – is associated with a higher mortality rate in people with community-acquired pneumonia.

In addition to Lilly’s trial of baricitinib as a mono therapy treatment, it is also collaborating on a study of the JAK inhibitor in combination with Gilead’s remdesivir run by the US National Institute of Allergy and Infectious Diseases (NIAID).