Gilead’s selonsertib crashes at Phase 3 in NASH
Gilead has broken the news that its apoptosis signal-regulating kinase 1 (ASK1) inhibitor selonsertib failed to meet its primary endpoint at Phase 3 in the treatment of bridging fibrosis (F3) due to nonalcoholic steatohepatitis (NASH).
When evaluated in 802 participants, the therapy failed to achieve a ≥ 1-stage histologic improvement in fibrosis without worsening of NASH in a pre-specified week 48 analysis. Just 9.3% of those taking an 18mg dose and 12.1% of those taking a 6mg dose achieved such an improvement compared to 13.2% with placebo.
“While we had hoped for different outcomes from the STELLAR programme, we remain focused and committed to developing highly effective treatments for patients living with advanced fibrosis due to NASH,” commented Dr John McHutchison, Chief Scientific Officer and Head of Research and Development at Gilead Sciences. “We are actively exploring the STELLAR data and will work with external collaborators like PathAI and insitro, to further our understanding of this complex disease and advance our development programmes.
“We believe that effective therapy for NASH will ultimately require a combination approach that targets distinct pathways involved in the pathogenesis of this disease. In this regard, we look forward to data from the Phase 2 ATLAS combination trial of selonsertib, cilofexor and firsocostat in patients with advanced fibrosis due to NASH, which will be available later this year,” he added.
Gilead said that it would now cooperate with the Data Monitoring Committee and investigators to conclude the drug’s ongoing study “in a manner consistent with the best interests of each patient.”
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