Eli Lilly has enrolled the first patient in a Phase III randomised, double-blind, placebo-controlled study that will assess the efficacy and safety of baricitinib in hospitalised adults with COVID-19.
Baricitinib, an oral JAK1/JAK2 inhibitor licensed from Incyte, is approved in 70 countries as a treatment for adults with moderately to severely active rheumatoid arthritis (RA).
The drug giant said it expects to enrol 400 patients in the trial, with data expected in the next few months.
The study is to be conducted in the US, UK, Europe and Latin America, and will include 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.
It is thought that through JAK1 and JAK2 inhibition, baricitinib may reduce the cytokine storm associated with the complications of this infection, and that the drug could also play a role in inhibiting the host cell proteins that assist in viral reproduction.
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).
Key secondary outcomes of this study include the proportion of patients with clinical improvement at different time points, time to recovery, duration of hospitalisation, number of ventilator-free days and mortality over a 28-day period.
“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.”
“Following upon the success of remdesivir to treat moderate to severe COVID-19, hospitalised patients are still in need of novel approaches to reduce mortality,” added Vincent C. Marconi, M.D., professor of medicine and global health at Emory University School of Medicine and Emory’s Rollins School of Public Health. “Several ongoing studies with baricitinib will provide necessary data about this treatment that may combine antiviral activity with suppression of cytokine storm.”
By: Selina McKee
Source: Pharma Times
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