Press release
Baricitinib in Combination with Remdesivir Reduces Time to Recovery in Hospitalized 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
About this update from Incyte Corporation
[{"type":"text","content":"- 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\n TORONTO, Sept. 17, 2020 (GLOBE NEWSWIRE) -- On Monday, September 14th, Eli Lilly and Company and Incyte announced 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 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 hospitalized 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, randomized 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. “As a tightly knit organization, we are truly working as one team to help discover a number of treatment options for COVID-19, including the potential role of baricitinib. We are pleased by the topline ACTT-2 results and look forward to the full data to completely understand baricitinib’s impact on COVID-19,” says Dr. Doron Sagman, Vice President, R&D and Medical Affairs, Eli Lilly Canada. Based on the ACTT-2 data, Lilly plans to discuss the potential for emergency use authorization (EUA...