Baricitinib in Combination with Remdesivir Reduces Time to Recovery in Hospitalised Patients with COVID-19 in NIAID-Sponsored ACTT-2 Trial

• Study Met Primary Endpoint of Reduction of Time to Recovery
• Additional Analyses Ongoing to Understand Other Clinical Outcome Data
• Lilly’s Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Baricitinib Continues

 BASINGSTOKE, September 14, 2020 – Eli Lilly and Company announced today initial data emerging from the Adaptive COVID-19 Treatment Trial (ACTT-2) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the United States National Institutes of Health (NIH). ACTT-2 included more than 1,000 patients and began on May 8 to assess the efficacy and safety of a 4-mg dose of baricitinib plus remdesivir versus remdesivir in hospitalized patients with COVID-19. Baricitinib in combination with remdesivir met the primary endpoint of reduction of time to recovery in comparison with remdesivir.

 Study investigators noted an approximately one-day reduction in median recovery time for the overall patient population treated with baricitinib in combination with remdesivir versus those treated with remdesivir. This finding was statistically significant. 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 hospitalised at Day 29. The study also met a key secondary endpoint comparing patient outcomes at Day 15 using an ordinal 8-point scale ranging from fully recovered to death.

 An independent data and safety monitoring board overseeing the double-blind, randomised controlled trial met regularly throughout the trial to review safety data. Additional analyses are ongoing to understand other clinical outcome data, including mortality and safety data. NIAID is expected to publish full details of the study in a peer-reviewed journal.

“We are pleased with these data from the ACTT-2 study,” said Patrik Jonsson, Lilly senior vice president and president of Lilly Bio-Medicines. “There is an urgent need to identify COVID-19 treatments, and we will continue to work with NIAID to understand these data and next steps on baricitinib’s role moving forward. We appreciate NIAID selecting baricitinib for inclusion in this important study and the participants, investigators and collaborators for the vital roles they played.” 

 “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 authorisation (EUA) with the U.S. Food and Drug Administration (FDA) and to explore similar measures with other regulatory agencies for baricitinib as a treatment of hospitalised patients with COVID-19. If authorised 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 review the ACTT-2 data with NIAID and assess any impact on COV-BARRIER, the Phase 3 randomised, double-blind, placebo-controlled study it initiated in June to evaluate the efficacy and safety of baricitinib versus background therapy in hospitalised 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, M.D., Ph.D., Lilly senior vice president and chief scientific officer. “These data allow us to better understand baricitinib’s role in potentially improving outcomes for hospitalised COVID-19 patients, and we look forward to continuing this research alongside our other initiatives to combat COVID-19.”

 Lilly is also currently supporting ongoing multisite and single-site investigator-initiated trials in Europe and North America for hospitalized patients with COVID-19 infections.