Gilead's NASH Drug Fails to Meet Late-Stage Study Goal

By Reuters Staff

April 26, 2019

(Reuters) - Gilead Sciences Inc's experimental drug aimed at treating nonalcoholic steatohepatitis (NASH) failed to meet the main goal of a late-stage study on Thursday, two months after it failed another.

STELLAR-3 was a Phase 3, 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 (ASK1), for patients with bridging fibrosis (F3) due to NASH.

The drug did not show an improvement in fibrosis symptoms, Gilead said.

The company in February said selonsertib had failed another trial testing patients with compensated cirrhosis, an advanced form of NASH.

In a statement, Dr. John McHutchison, Chief Scientific Officer and Head of Research and Development, Gilead Sciences, said: "We believe that effective therapy for NASH will ultimately require a combination approach that targets distinct pathways involved in the pathogenesis of this disease. 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."

Analysts have projected the market for NASH treatments to reach $20 billion to $35 billion as people with fatty diets increasingly develop the disease.