United States-based Gilead Sciences has revealed top-line data from the phase three Stellar-four study of its liver disease treatment, selonsertib, in compensated cirrhosis (F4) due to nonalcoholic steatohepatitis (NASH), it was reported yesterday.

The product has failed to meet the pre-specified week 48 primary endpoint of an up to one-stage histologic improvement in fibrosis without worsening of NASH. It is an investigational, once-daily and oral inhibitor of apoptosis signal-regulating kinase one (ASK1), which promotes inflammation, apoptosis (cell death) and fibrosis in settings of oxidative stress.

Stellar-4 is a phase three randomised, double-blind and placebo-controlled study designed to evaluate the safety and efficacy of the product in patients with F4 due to NASH.

According to the company, the 877-patient study indicated that 14.4% of patients treated with selonsertib 18mg and 12.5% of patients treated with selonsertib 6mg achieved an up to one-stage improvement in fibrosis as per the NASH Clinical Research Network classification without worsening of NASH after 48 weeks of treatment, compared against 12.8% of patients who received placebo.

The company will work with the Data Monitoring Committee and investigators to complete the Stellar-four study without compromising on the interests of each patient.