Eli Lilly has commenced a phase 3 clinical trial with baricitinib, marketed as Olumiant, for hospitalised Covid-19 patients.
The phase 3 randomised, double-blind and placebo-controlled study will assess the efficacy and safety of baricitinib, an oral JAK1/JAK2 inhibitor licenced from Incyte, in hospitalised adults with Covid-19.
Baricitinib secured approval in around 70 countries for the treatment of adults with moderately to severely active rheumatoid arthritis (RA).
In December 2009, Lilly and Incyte entered an exclusive worldwide licence and collaboration agreement to develop and commercialise baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases.
Lilly is planning to recruit up to 400 patients in the trial at the centres in the US Europe and Latin America. The data from the trial is expected to be revealed within a few months.
The trial will comprise of patients hospitalised with SARS-CoV-2 infection who have at least one elevated marker of inflammation and does not need invasive mechanical ventilation at study entry.
Baricitinib is believed to minimise the cytokine storm associated with the complications of this infection through JAK1 and JAK2 inhibition. It is also expected to inhibit the host cell proteins that support viral reproduction.
According to the company, the trial’s primary endpoint 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).
Patients will be provided with baricitinib or placebo for up to 14 days or until discharge from the hospital. Major secondary outcomes of the trial comprise of 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.
The data from the study is said to complement data from the study of baricitinib with remdesivir in the second phase of the Adaptive Covid-19 Treatment Trial (ACTT-2) conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
The ACTT-2 trial is evaluating the efficacy and safety of the combination of a 4-mg daily dose of baricitinib plus remdesivir, compared to remdesivir.
Lilly Bio-Medicines president and senior vice president Patrik Jonsson 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 randomised controlled study is an important step in our understanding of baricitinib as a potential Covid-19 treatment.”
In May this year, Eli Lilly collaborated with Junshi Biosciences for the development of therapeutic antibodies to treat and prevent Covid-19, the disease resulted due to the SARS-CoV-2 novel coronavirus.