Selonsertib has failed to meet the pre-specified week 48 primary endpoint of a ≥ 1-stage histologic improvement in fibrosis without worsening of NASH.
Stellar-4 is a phase 3 randomized, double-blind and placebo-controlled study designed to assess the safety and efficacy of selonsertib in patients with compensated cirrhosis (F4) due to NASH.
According to the company, the 877-patient study showed that 14.4% of patients treated with selonsertib 18mg and 12.5% of patients treated with selonsertib 6mg achieved a ≥ 1-stage improvement in fibrosis as per the NASH Clinical Research Network (CRN) classification without worsening of NASH after 48 weeks of treatment, compared against 12.8% of patients who received placebo.
Gilead will work with the Data Monitoring Committee and investigators to complete the Stellar-4 study without compromising on the interests of each patient.
Selonsertib is an investigational, once-daily and oral inhibitor of apoptosis signal-regulating kinase 1 (ASK1), which promotes inflammation, apoptosis (cell death) and fibrosis in settings of oxidative stress
Selonsertib, cilofexor and firsocostat, alone or in combination, are investigational compounds, and did not secured approval from the US Food & Drug Administration (FDA) or any other regulatory authority.
Selonsertib, cilofexor and firsocostat, alone or in combination, are investigational compounds and are not approved by the U.S. Food & Drug Administration (FDA) or any other regulatory authority. Safety and efficacy have not been established for these agents.
Gilead research and development head and chief scientific officer Dr John McHutchison said: “While we are disappointed that the STELLAR-4 study did not achieve its primary endpoint, we remain committed to advancing therapies for patients with advanced fibrosis due to NASH, where there is a significant unmet need for effective and well-tolerated treatments.
“Gilead has a long-term commitment and proven track record of addressing significant challenges in the field of liver diseases. Data from this large study of patients with compensated cirrhosis due to NASH, including the extensive set of biomarkers collected, will further advance our understanding of the disease and inform our broader NASH development programs.”