Eli Lilly and Company is partnering with the National Institute of Allergy and Infectious Diseases at NIH to study the effectiveness of its rheumatoid arthritis drug baricitinib (Olumiant) in combatting COVID-19.
The RA, lupus, and anti-malaria treatment hydroxychloroquine is also being tested to treat COVID-19, while Genentech recently obtained FDA approval for its clinical trial to assess its RA drug tocilizumab (Actemra) in severe COVID-19-caused pneumonia.
The Eli Lilly trial will start in the U.S. in April, and then expand to additional sites, including Europe and Asia. The pharma maker expects results in the next two months, it said in a press release.
"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, MD, 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.”
Baricitinib, an oral JAK1/JAK2 inhibitor, is approved in more than 65 countries as a treatment for adults with moderately to severely active RA.
The U.S. prescribing information includes boxed warnings regarding the use of baricitinib, including warnings about risk for developing serious infections — which 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,” Eli Lilly said.
Eli Lilly is also advancing 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.
The trial will begin later this month at several U.S. centers.
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