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April 26, 2019

Gilead’s selonsertib fails in second Phase III trial for NASH

Gilead Sciences has reported that selonsertib failed to meet the primary endpoint in the Phase III STELLAR-3 clinical trial performed in patients with bridging fibrosis (F3) caused by nonalcoholic steatohepatitis (NASH).

Gilead Sciences has reported that selonsertib failed to meet the primary endpoint in the Phase III STELLAR-3 clinical trial performed in patients with bridging fibrosis (F3) caused by nonalcoholic steatohepatitis (NASH).

The announcement comes two months after the apoptosis signal-regulating kinase 1 (ASK1) inhibitor failed to demonstrate positive outcomes in the Phase III STELLAR-4 study.

In the STELLAR-3 trial, the drug did not meet the primary endpoint of a ≥1-stage histologic improvement in fibrosis without worsening NASH at week 48.

The trial investigated the safety and efficacy of selonsertib in a total of 802 patients. 9.3% of patients on 18mg selonsertib and 12.1% on 6mg dose achieved the primary endpoint.

“We believe that effective therapy for NASH will ultimately require a combination approach that targets distinct pathways.”

However, the figure was observed to be 13.2% in the placebo arm. The data also showed that selonsertib was generally well tolerated and its safety profile was consistent with previous trials.

Gilead Sciences chief scientific officer and Research and Development head John McHutchison said: “We believe that effective therapy for NASH will ultimately require a combination approach that targets distinct pathways involved in the pathogenesis of this disease.

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“In this regard, we look forward to data from the Phase II ATLAS combination trial of selonsertib, cilofexor and firsocostat in patients with advanced fibrosis due to NASH, which will be available later this year.”

The randomised, double-blind, placebo-controlled STELLAR-3 trial also involved another primary endpoint of event-free survival as measured by time to the first clinical event at week 240.

Secondary endpoints of the study included proportion of patients with a ≥1-stage improvement in fibrosis without worsening NASH at week 240 and those with NASH resolution without worsening fibrosis at week 48 and week 240.

The company is set to work with the Data Monitoring Committee and investigators to appropriately conclude the STELLAR-3 trial.

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