Gilead’s selonsertib fails Phase III for NASH compensated cirrhosis

Gilead Sciences Inc. (NASDAQ:GILD) said selonsertib (GS-4997) missed the primary endpoint in the Phase III STELLAR-4 trial to treat compensated cirrhosis due to non-alcoholic steatohepatitis (NASH). Selonsertib is an oral small molecule ASK1 inhibitor.

The primary endpoint measured the percent of patients who achieved a histologic improvement in fibrosis of at least one stage according to the NASH Clinical Research Network (CRN) classification without worsening of NASH after 48 weeks of treatment. Among 877 adults enrolled, 12.5% of patients that received 6 mg once-daily selonsertib (p=1) and 14.4% of patients dosed with 18 mg once-daily selonsertib achieved the endpoint vs. 12.8% of patients that received placebo...