Gilead says selonsertib Phase 3 STELLAR-3 Study did not meet primary endpoint
Gilead Sciences announced that STELLAR-3, a Phase 3, 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, or ASK1, for patients with bridging fibrosis, or F3, due to nonalcoholic steatohepatitis, or NASH, did not meet the pre-specified week 48 primary endpoint of a greater than or equal to 1-stage histologic improvement in fibrosis without worsening of NASH. In the study of 802 enrolled and dosed patients, 9.3 percent of patients treated with selonsertib 18 mg and 12.1 percent of patients treated with selonsertib 6 mg achieved a greater than or equal to 1-stage improvement in fibrosis according to the NASH Clinical Research Network, or CRN, classification without worsening of NASH after 48 weeks of treatment, versus 13.2 percent with placebo. Selonsertib was generally well tolerated and safety results were consistent with prior studies. Gilead will now work with the Data Monitoring Committee and investigators to conclude the STELLAR-3 study in a manner consistent with the best interests of each patient. Selonsertib, cilofexor, and firsocostat, alone or in combination, are investigational compounds and are not approved by the FDA or any other regulatory authority. Safety and efficacy have not been established for these agents.