Eli Lilly and Wilmington-based Incyte announced promising results from the Adaptive Covid-19 Treatment Trial sponsored by a unit of the National Institutes.
The ACTT-2 trial included more than 1,000 patients and began on May 8 to assess the effectiveness and safety of a 4-mg dose of arthritis drug baricitinib plus remdesivir in hospitalized patients with Covid-19.
Study investigators noted an approximately one-day reduction in median recovery time for the overall patient population treated with baricitinib branded asOlumiant in combination with remdesivir versus those treated with remdesivir alone.
Recovery was defined as the participant being well enough for hospital discharge, meaning the participant either no longer required supplemental oxygen or ongoing medical care in the hospital, or was no longer hospitalized at Day 29.
Covid-19 treatment is intense and expensive for seriously ill patients.
Additional analyses are ongoing to understand other clinical outcome data, including mortality and safety data.
“These findings from ACTT-2 are another step as we improve the care of these patients,” said Andre Kalil, M.D., professor at the University of Nebraska Medical Center and a principal investigator of the ACTT studies. “These data may help us to better understand baricitinib’s potential role in the treatment of COVID-19.”
Based on the ACTT-2 data, Lilly plans to discuss the potential for emergency use authorization with the U.S. Food and Drug Administration (FDA) and to explore similar measures with other regulatory agencies for baricitinib as a treatment of hospitalized patients with Covid-19.
If authorized for use, Lilly will propose that baricitinib be available through commercial channels and will work with hospitals and governments to ensure patient access.
Lilly will continue to create adequate supply for rheumatoid arthritis (RA) patients and ensure baricitinib remains available in countries where it is approved including the U.S.
Lilly will review the ACTT-2 data with NIAID and assess any impact on COV-BARRIER, the Phase 3 study it initiated in June to evaluate the efficacy and safety of baricitinib versus background therapy in hospitalized adults with Covid-19 in the U.S., Europe, Asia and Latin America.
“As a company, we’ve moved quickly to develop and evaluate medicines for patients for the prevention and treatment of Covid-19,” said Daniel Skovronsky, Lilly senior vice president and chief scientific officer. “These data allow us to better understand baricitinib’s role in potentially improving outcomes for hospitalized COVID-19 patients, and we look forward to continuing this research alongside our other initiatives to combat Covid-19.”
Incyte and Lilly co-developed baricitinib. Incyte decided to turn over further development to Lilly, with Incyte but collects royalties from sales. This occurred after the FDA limited dosages of the drug due to side effects.
The FDA decision kept the drug from becoming a blockbuster. However, sales have been growing, with Covid-19 treatment a potential market.
The list price of Olumiant is $2,265 for 15 days of 4 mg. dosages.
Lilly is currently supporting ongoing multisite and single-site investigator-initiated trials in Europe and North America for hospitalized patients with Covid-19 infections.