Baricitinib misses goal in Phase III hospitalized COVID-19 patient study

US pharma major Eli Lilly (NYSE: LLY) and partner Incyte (Nasdaq: INCY) announced disappointing results of COV-BARRIER, a Phase III study evaluating the rheumatoid arthritis drug baricitinib 4mg once daily plus standard of care (SoC) versus placebo plus SoC.

The trial did not meet statistical significance on the primary endpoint, which was defined as a difference in the proportion of participants progressing to the first occurrence of non-invasive ventilation including high flow oxygen or invasive mechanical ventilation including extracorporeal membrane oxygenation (ECMO) or death by Day 28. Baricitinib-treated patients were 2.7% less likely than those receiving standard of care to progress to ventilation (non-invasive or mechanical) or death, a difference that was not statistically significant (odds ratio [OR]: 0.85; 95% CI 0.67, 1.08; p=0.1800).

This is a second disappoint for Lilly in its coronavirus ambitions, as a couple of weeks ago, the US government said it will no longer distribute the COVID-19 monoclonal antibody therapy bamlanivimab for use on its own.