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.
For more information visit Gilead.com.
This article originally appeared on MPR