Gilead announced that STELLAR-3, a Phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of selonsertib for patients with bridging fibrosis (F3) due to nonalcoholic steatohepatitis (NASH), did not meet the pre-specified week 48 primary endpoint of a ≥ 1-stage histologic improvement in fibrosis without worsening of NASH.
STELLAR-3 enrolled 802 enrolled patients who were randomized to receive selonsertib 18 mg (n=322), selonsertib 6 mg (n=321) or placebo (n=159), orally once daily, for up to 240 weeks. The percentage of patients achieving a ≥ 1-stage improvement in fibrosis according to the NASH Clinical Research Network (CRN) classification without worsening of NASH after 48 weeks of treatment is as follows: selonsertib 18 mg arm, 9.3% and selonsertib 6 mg arm, 12.1% versus 13.2% with placebo. Selonsertib was generally well tolerated and safety results were consistent with prior studies.
Gilead is working with the Data Monitoring Committee and investigators to conclude the STELLAR-3 study in a manner consistent with the best interests of each patient.
NASH is a chronic and progressive liver disease characterized by fat accumulation and inflammation in the liver, which can lead to scarring, or fibrosis, that impairs liver function. Individuals with advanced fibrosis are at a significantly higher risk of liver-related mortality and all-cause mortality.
Selonsertib is a small molecule inhibitor of ASK1, a protein that promotes inflammation, apoptosis (cell death) and fibrosis in settings of oxidative stress. Oxidative stress can be increased in many pathological conditions including liver diseases such as NASH.