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Gilead Sciences Late-Stage Study Of Selonsertib Fails To Meet Primary Endpoint

Gilead Sciences Inc. (GILD) Monday said a phase 3 Stellar-4 study of Selonsertib did not meet primary goals.

The randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of selonsertib, an investigational, once-daily, oral inhibitor of apoptosis signal-regulating kinase 1, in patients with compensated cirrhosis due to nonalcoholic steatohepatitis, did not meet the pre-specified week 48 primary endpoint of a = 1-stage histologic improvement in fibrosis without worsening of NASH.

"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," said John McHutchison, Chief Scientific Officer, Head of Research and Development, Gilead.

In the study of 877 enrolled patients who received study drug, 14.4 percent of patients treated with selonsertib 18 mg and 12.5 percent of patients treated with selonsertib 6 mg 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.

"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."

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