Topline data from the Phase 3 STELLAR-4 trial showed that selonsertib, an investigational treatment for patients with compensated cirrhosis due to nonalcoholic steatohepatitis (NASH), was not associated with a significant improvement in fibrosis without worsening of NASH.
The safety and efficacy of selonsertib, an oral inhibitor of apoptosis signal-regulating kinase 1 (ASK1), was evaluated in a double-blind, placebo-controlled trial involving 877 patients with compensated cirrhosis (F4) due to NASH. Patients were randomized to receive selonsertib 18mg (N=354), selonsertib 6mg (N=351), or placebo (N=172) once daily for up to 240 weeks. The primary endpoints of the study included a composite of the proportion of patients who achieved a ≥1-stage improvement in fibrosis according to the NASH CRN classification without worsening of NASH at 48 weeks and event-free survival at week 240 as assessed by time to the first clinical event.
Results showed that the study did not meet the week 48 primary endpoint, with 14.4% of the selonsertib 18mg group and 12.5% of the selonsertib 6mg group achieving a ≥ 1-stage improvement in fibrosis without worsening of NASH, compared with 12.8% of patients in the placebo arm. Based on these findings, Gilead has made the decision to conclude the STELLAR-4 study.
“We are grateful to the patients and investigators who participated in the STELLAR-4 study, and we now await the upcoming results from the Phase 3 STELLAR-3 trial of selonsertib in patients with bridging fibrosis (F3) due to NASH and the Phase 2 ATLAS combination trial of selonsertib, cilofexor (GS-9674) and firsocostat (GS-0976) in patients with advanced fibrosis due to NASH later this year,” said John McHutchison, AO, MD, Chief Scientific Officer, Head of Research and Development, Gilead.
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