Eli Lilly announced that it has reached an agreement with the US National Institute of Allergy and Infectious Diseases (NIAID) to begin testing Olumiant (baricitinib) as a potential treatment for hospitalised patients diagnosed with COVID-19. The oral JAK1/JAK2 inhibitor, which will be evaluated in one of the arms of the NIAID's Adaptive COVID-19 Treatment study, will be tested in the US starting this month, with data expected in the next two months, and later expanded to additional sites, including in Europe and Asia.
The company said it is also advancing LY3127804, an investigational selective monoclonal antibody against Ang2, into Phase II testing later this month in the US for potential use in pneumonia patients hospitalised with COVID-19 who are at higher risk of progressing to acute respiratory distress syndrome (ARDS). "Ang2 is known to be elevated in ARDS patients," Eli Lilly noted, adding that the study will look at whether inhibiting the effects of Ang2 with a monoclonal antibody can reduce the progression to ARDS or the need for mechanical ventilation.
In regards to Olumiant, Eli Lilly suggested that the drug's anti-inflammatory activity may help to tamp down the inflammatory cascade seen in certain patients with COVID-19. "There is an urgent need for new strategies to help hospitalised COVID-19 patients, many of whom will progress to respiratory failure," remarked Vincent Marconi, professor of medicine and global health at Emory University School of Medicine, one of the US sites for NIAID's ongoing trial, adding this study "presents an important opportunity to test whether [Olumiant] can help these patients."
Olumiant, which Eli Lilly develops and markets together with Incyte, is approved in the US, Europe and Japan to treat certain patients with rheumatoid arthritis. Earlier this month, Incyte and partner Novartis also announced plans to initiate Phase III testing of their JAK1/JAK2 inhibitor ruxolitinib in patients suffering from COVID-19-associated cytokine storm. That drug is marketed by Incyte as Jakafi in the US, and by Novartis outside of the country under the name Jakavi.
Meanwhile, Eli Lilly indicated that it currently does not anticipate shortages for any of its medicines, including Olumiant, which it says "remains widely available" in countries where the drug is approved. The company added that "should research efforts for [Olumiant] in COVID-19 prove successful, [we] will continue to create adequate supply to support both appropriate clinical and investigational use."
Late last month, Eli Lilly stated that it would postpone most new study starts, and temporarily suspend recruiting new patients or healthy volunteers in most of its ongoing trials in light of the COVID-19 pandemic. For related analysis, see ViewPoints: Impact of COVID-19 on clinical trial enrolment comes into view.
To read more Top Story articles, click here.