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Phase 3 Trial of Selonsertib for NASH-fibrosis Reduction Fails to Meet Primary Endpoint
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Gilead Sciences announced that the STELLAR-3 phase 3 study of selonsertib for patients with bridging fibrosis due to nonalcoholic steatohepatitis did not meet the prespecified 48-week primary endpoint of 1-stage or more histological improvement in fibrosis without worsening of nonalcoholic steatohepatitis, according to a press release.
“While we had hoped for different outcomes from the STELLAR program, we remain focused and committed to developing highly effective treatments for patients living with advanced fibrosis due to NASH,” John G. McHutchison, AO, MD, chief scientific officer and head of research and development at Gilead Sciences, said in the release. “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 programs.”
The randomized control study comprised 802 patients. At 48 weeks, 9.3% of patients who received selonsertib 18 mg and 12.1% who received selonsertib 6 mg achieved a 1-stage or more improvement in fibrosis compared with 13.2% of patients who received placebo.
Safety results and tolerability profile were consistent with prior studies.
According to the release, Gilead will now work with the Data Monitoring Committee and investigators to conclude the phase 3 study in a manner consistent with the best interests of each patient.
“We believe that effective therapy for NASH will ultimately require a combination approach that targets distinct pathways involved in the pathogenesis of this disease,” McHutchison said in the release. “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.”
Cilofexor, a farnesoid X receptor agonist, and firsocostat, a small molecule and an oral allosteric acetyl CoA carboxylase inhibitor, are both under investigation by Gilead Sciences.
Reference: www.gilead.com