Gilead's selonsertib heading for Phase III NASH trial

Gilead Sciences Inc. (NASDAQ:GILD) said anti-fibrotic activity shown in a Phase II study of selonsertib ( GS-4997) to treat non-alcoholic steatohepatitis warrants advancement of the compound into Phase III testing in the indication.

Among 67 evaluable patients in the open-label Phase II trial, high and low doses of selonsertib plus simtuzumab ( GS-6624) led to fibrosis improvements at 24 weeks of at least one stage from baseline in 43% and 30% of patients, respectively, compared with 20% for simtuzumab alone. Fibrosis stage was determined according to the NASH Clinical Research Network (CRN) classification. ...