Gilead Sciences has announced topline data from the phase 3 Stellar-4 study of its liver disease treatment selonsertib in compensated cirrhosis (F4) due to nonalcoholic steatohepatitis (NASH).
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.