Results from the STELLAR-4 phase 3 study showed that selonsertib did not meet the pre-specified 48-week endpoint of histologic improvement by 1 or more stage in fibrosis without worsening of nonalcoholic steatohepatitis, according to a press release.
“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,” John McHutchison, AO, MD, chief scientific officer and head of research and development at Gilead, said in the release. “Gilead has a long-term commitment and proven track record of addressing significant challenges in the field of liver diseases.”
The study comprised 877 patients with NASH and compensated cirrhosis. At study end, 14.4% of those who received 18 mg of selonsertib and 12.5% of those who received 6 mg of selonsertib achieved an improvement in fibrosis by 1 or more stage. Selonsertib was generally well-tolerated and safety results were consistent with prior studies.
Gilead reports that further in-depth analysis of the findings is ongoing, and the data will be submitted to an upcoming scientific conference.
“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 programs,” McHutchinson said in the release.