13 April 2020 | News
Lilly Starts Phase 2 Trial with Anti-Ang2 in COVID-19
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Eli Lilly and Company announced that 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.