Baricitinib has Significant Effect on Recovery Time, Most Impactful in Patients with COVID-19 Requiring Oxygen

Further results from NIAID-sponsored ACTT-2 Trial

TORONTO, Oct. 16, 2020 /CNW/ - Eli Lilly and Company and Incyte shared additional data that showed baricitinib in combination with remdesivir reduced time to recovery and improved clinical outcomes for patients with COVID-19 infection compared with remdesivir. This finding was part of additional efficacy and safety data 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), which was presented on October 8^th  by John Beigel, M.D., associate director for clinical research in the Division of Microbiology and Infectious Diseases at NIAID. These data were presented at a special International Society for Influenza and other Respiratory Virus Diseases Antiviral Group (isirv-AVG) Virtual Conference on 'Therapeutics for COVID-19.' The largest benefits were observed in patients requiring supplemental oxygen (grade 5 on the eight-point ordinal scale) and those who required high-flow oxygen/non-invasive ventilation (grade 6) at baseline.

The new data provide a better understanding of the improved clinical outcomes in hospitalized adults with COVID-19 infection who received baricitinib, including data for mortality. As previously reported, ACTT-2 achieved the primary endpoint, demonstrating that the overall patient population treated with baricitinib in combination with remdesivir improved their median time to recovery from 8 to 7 days in comparison to remdesivir, a 12.5% improvement (incidence rate ratio: 1.16; 95% CI: 1.01, 1.32; p=0.04). 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 pre-specified secondary endpoint. Using the ordinal scale that ranged from recovered to death, the odds of improvement in clinical status at Day 15 were 30% greater in patients being treated with baricitinib in combination with remdesivir compared with remdesivir (odds ratio 1.3; 95% CI: 1.0, 1.6; p=0.04).

A numerical decrease in death (35%) through Day 29 was observed in patients treated with baricitinib plus remdesivir compared to remdesivir in the overall population (5.1% vs. 7.8%, respectively; hazard ratio: 0.65; 95% CI: 0.39, 1.08; p=0.09). The reduction in mortality was more pronounced for patients receiving oxygen, as mortality at Day 29 was 60% lower and 43% lower for the OS5 and OS6 subgroups respectively. No new safety signals were observed for baricitinib-treated patients in this study. NIAID authors are working to have the full analysis completed and a peer-reviewed manuscript will be made available soon.

"We are very pleased to learn that baricitinib in combination with remdesivir has demonstrated further positive results and clinical improvement in hospitalized patients with COVID-19," says Dr. Doron Sagman, vice president, R&D and Medical Affairs, Eli Lilly Canada. "We look forward to learning more about the potential role for baricitnib to treat hospitalized patients with COVID-19 through the full data analysis."

Lilly is continuing conversations with the U.S. Food and Drug Administration (FDA) around the potential for Emergency Use Authorization (EUA) of baricitinib as a treatment for hospitalized patients with COVID-19, and will explore similar measures with other regulatory agencies, including Health Canada. Baricitinib has not been approved by the FDA, or any regulatory agency, to treat COVID-19; the efficacy and safety of baricitinib for the treatment of COVID-19 has not been established.

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®
OLUMIANT is a once-daily, oral Janus Kinase (JAK) inhibitor. 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

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.

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

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.

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about OLUMIANT (baricitinib) as a potential treatment for patients with COVID-19 and as a treatment for patients with rheumatoid arthritis, and reflects Lilly's and Incyte's current beliefs. This press release also contains a forward-looking statement about Lilly's potential antibody treatments for COVID-19. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that OLUMIANT will receive additional regulatory approvals or continue to be commercially successful, or that potential antibody treatments will be safe and effective. For further discussion of these and other risks and uncertainties, see Lilly's and Incyte's most recent respective Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly and Incyte undertake no duty to update forward-looking statements to reflect events after the date of this release.

References

^1	Olumiant Product Monograph, 2020.
^2	Walker JG and Smith MD. J Rheumatol. 2005;32;1650-1653.

SOURCE Eli Lilly Canada Inc.

Media Contact: Samira Rehman, [email protected], 647-617-1994