Gilead's Phase III STELLAR-4 study of selonsertib fails in NASH

Having invested significantly in building a pipeline of non-alcoholic steatohepatitis (NASH) drugs, US biotech major Gilead Sciences (Nasdaq: GILD) suffered a setback with its candidate selonsertib in a late stage trial, with the news pushing the firm’s shares 2.4% lower to $66.00 in after-hours trading on Monday.

Gilead announced that STELLAR-4, a Phase III, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of selonsertib, an investigational, once-daily, oral inhibitor of apoptosis signal-regulating kinase 1 (ASK1), in patients with compensated cirrhosis (F4) due to NASH, did not meet the pre-specified week 48 primary endpoint of a ≥ 1-stage histologic improvement in fibrosis without worsening of NASH.

In the study of 877 enrolled patients who received study drug, 14.4% of patients treated with selonsertib 18mg (p=0.56 versus placebo) and 12.5% of patients treated with selonsertib 6mg (p=1.00) achieved a ≥ 1-stage improvement in fibrosis according to the NASH Clinical Research Network (CRN) classification without worsening of NASH after 48 weeks of treatment, compared with 12.8% of patients who received placebo. Selonsertib was generally well-tolerated and safety results were consistent with prior studies.