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) with the U.S. Food and Drug Administration (FDA) and to explore similar measures with other regulatory agencies, including Health Canada, for baricitinib as a treatment of hospitalized patients with COVID-19. If authorized for use in Canada, 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 Canada and around the world where it is approved. In Canada, baricitinib is approved for RA patients at a 2-mg daily dose.
Lilly will review the ACTT-2 data with NIAID and assess any impact on COV-BARRIER, the Phase 3 randomized, double-blind, placebo-controlled 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.
Lilly is also currently supporting ongoing multisite and single-site investigator-initiated trials in Europe and North America, including the SAIL-004 study in Nova Scotia, Canada, in hospitalized patients with COVID-19 infections.