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 Randomized, Double-Blind, Placebo-Controlled Study of Baricitinib Continues

TORONTO, Sept. 17, 2020 (GLOBE NEWSWIRE) -- On Monday, September 14 th , 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.

About Lilly’s COVID-19 Efforts Lilly is bringing the full force of its scientific and medical expertise to attack the coronavirus pandemic around the world. Existing Lilly medicines are now being studied to understand their potential in treating complications of COVID-19, and the company is collaborating with two partner companies to discover novel antibody treatments for COVID-19. Lilly intends to test both single antibody therapy as well as combinations of antibodies (sometimes known as antibody cocktails) as potential therapeutics for COVID-19.

About OLUMIANT ® In Canada, OLUMIANT (baricitinib), in combination with methotrexate (MTX), is indicated for reducing the signs and symptoms of moderate- to severe rheumatoid arthritis (RA) in adult patients who have responded inadequately to one or more disease-modifying anti-rheumatic drugs (DMARDs). OLUMIANT can be used as a monotherapy in cases of intolerance to MTX. 1

OLUMIANT is believed to interfere with the activity of an enzyme called Janus Kinase (JAK). Normally JAK enzymes help turn on your immune system when you need it. The immune system then causes swelling and tenderness. This is called inflammation. There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases. 2 OLUMIANT has greater inhibitory potency at JAK1, JAK2 and TYK2 relative to JAK3; however, the relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.

About Lilly Canada Eli Lilly and Company is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by Colonel Eli Lilly, who was committed to creating high quality medicines that meet people’s needs, and today we remain true to that mission in all our work. Lilly employees work to discover and bring life-changing medicines to people who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism.

Eli Lilly Canada was established in 1938, the result of a research collaboration with scientists at the University of Toronto, which eventually produced the world’s first commercially available insulin. Our work focuses on oncology, diabetes, autoimmunity, neurodegeneration, and pain. To learn more about Lilly Canada, please visit us at www.lilly.ca .

About Incyte Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

For our perspective on issues in healthcare and innovation, follow us on twitter @LillyPadCA and @LillyMedicalCA

Media Contact: Samira Rehman Rehman_Samira@lilly.com 647-617-1994

References 1 OLUMIANT Product Monograph 2 Walker JG and Smith MD. J Rheumatol. 2005;32;1650-1653.