Gilead’s selonsertib has failed to hit a key target in a late-stage study involving patients with compensated cirrhosis due to nonalcoholic steatohepatitis (NASH).
Topline data from the Phase III STELLAR-4 trial showed that the oral apoptosis signal-regulating kinase 1 inhibitor did not meet the pre-specified week 48 primary endpoint of a ≥ 1-stage histologic improvement in fibrosis without worsening of NASH.
Of 877 enrolled patients who received study drug, 14.4% treated with selonsertib 18mg and 12.5% of those given selonsertib 6mg achieved a ≥ 1-stage improvement in fibrosis according to the NASH Clinical Research Network (CRN) classification without worsening of NASH after 48 weeks of treatment, compared with 12.8 percent of patients who received placebo.
On the plus side, selonsertib was generally well-tolerated and safety results were consistent with prior studies, the firm noted.
“While we are disappointed that the STELLAR-4 study did not achieve its primary endpoint, we remain committed to advancing therapies for patients with advanced fibrosis due to NASH, where there is a significant unmet need for effective and well-tolerated treatments,” noted John McHutchison, chief scientific officer, head of Research and Development, at Gilead.
Data from this large study of patients with compensated cirrhosis due to NASH, including the extensive set of biomarkers collected, will further advance our understanding of the disease and inform our broader NASH development programmes,” he added.
The firm is now awaiting upcoming results from the Phase III STELLAR-3 trial of selonsertib in patients with bridging fibrosis (F3) due to NASH and the Phase II ATLAS combination trial of selonsertib, cilofexor (GS-9674) and firsocostat (GS-0976) in patients with advanced fibrosis due to NASH, expected later this year.