Gilead has announced that STELLAR-4, a phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of selonsertib, an investigational, once-daily, oral inhibitor of ASK1, in patients with compensated cirrhosis due to nonalcoholic steatohepatitis (NASH), failed to meet the week 48 primary endpoint of a ≥ 1-stage histologic improvement in fibrosis without worsening of NASH. Essentially, the med was no more effective than a placebo.
In the study of 877 enrolled patients who received study drug, 14.4 percent of patients treated with selonsertib 18 mg (p=0.56 vs. placebo) and 12.5 percent of patients treated with selonsertib 6 mg (p=1.00) achieved a ≥ 1-stage improvement in fibrosis according to the NASH Clinical Research Network classification without worsening of NASH after 48 weeks of treatment, compared with 12.8 percent of patients who received placebo. Selonsertib was generally well-tolerated and safety results were consistent with prior studies.
Selonsertib was considered the company's frontrunner treatment, and while it has others in the pipeline this failure puts Gilead off track from possibly being first to market.
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