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Eli Lilly enters agreement with NIH to study baricitinib as an arm in NIAID's Adaptive COVID-19 Treatment Trial

Indianapolis
Monday, April 13, 2020, 09:00 Hrs  [IST]

Eli Lilly and Company 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 US 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 US 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 US 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 US 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.

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.

 

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