INDIANAPOLIS, April 10, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today it has entered into an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to study baricitinib as an arm in NIAID's Adaptive COVID-19 Treatment Trial. The study will investigate the efficacy and safety of baricitinib as a potential treatment for hospitalized patients diagnosed with COVID-19, beginning this month in the U.S. with a planned expansion to additional sites including Europe and Asia. Results are expected within the next two months.

Baricitinib, an oral JAK1/JAK2 inhibitor marketed as OLUMIANT®, is approved in more than 65 countries as a treatment for adults with moderately to severely active rheumatoid arthritis. The U.S. prescribing information includes boxed warnings regarding the use of baricitinib, including warnings about risk for developing serious infections, a risk that may be related to baricitinib's effects on the immune system. Given the inflammatory cascade seen in COVID-19, baricitinib's anti-inflammatory activity has been hypothesized to have a potential beneficial effect in COVID-19 and warrants further study in patients with this infection. 

Joining the NIAID study is just one approach Lilly is taking to tackle the COVID-19 global health crisis. Lilly is also announcing today that it will advance LY3127804, an investigational selective monoclonal antibody against Angiopoietin 2 (Ang2), to Phase 2 testing in pneumonia patients hospitalized with COVID-19 who are at a higher risk of progressing to acute respiratory distress syndrome (ARDS). Ang2 is known to be elevated in ARDS patients and Lilly will test whether inhibiting the effects of Ang2 with a monoclonal antibody can reduce the progression to ARDS or the need for mechanical ventilation in COVID-19 patients. This trial will begin later this month at several U.S. centers.  

"Lilly is moving at top speed and using all available resources to help fight this pandemic," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories. "Developing potential therapeutic medicines for COVID-19 is part of our vital and humanitarian mission. To be successful, we must combine resources, data and expertise, with government, academia and other companies. We look forward to seeing the results of baricitinib and anti-Ang2 clinical studies."

"There is an urgent need for new strategies to help hospitalized COVID-19 patients, many of whom will progress to respiratory failure," said Vincent C. Marconi, M.D., professor of medicine and global health at Emory University School of Medicine, one of the U.S. sites for NIAID's ongoing Adaptive COVID-19 Treatment Trial. "This NIAID study presents an important opportunity to test whether baricitinib can help these patients."

Lilly currently does not anticipate shortages for any of its medicines, including baricitinib, which remains widely available in countries where it is approved. Should research efforts for baricitinib in COVID-19 prove successful, Lilly will continue to create adequate supply to support both appropriate clinical and investigational use.

Indication and Usage for OLUMIANT (baricitinib) tablets (in the United States) for RA patients

OLUMIANT® (baricitinib) 2-mg is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Limitation of Use: Use of OLUMIANT in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended. 

About OLUMIANT®

OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF inhibitor therapies, and approved outside of the U.S. for patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs.i 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.ii 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.i

In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases.

About Eli Lilly and Company 

Lilly is a global healthcare leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channels. P-LLY

i Olumiant Prescribing Information, 2019.
ii Walker JG and Smith MD. J Rheumatol. 2005;32;1650-1653.

 SOURCE Eli Lilly and Company