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Gilead's Failed NASH Drug Trial Drags Stock Lower

Gilead's Failed NASH Drug Trial Drags Stock Lower

Gilead Sciences, Inc. (NASDAQ: GILD) is facing another setback, as its non-alcoholic steatohepatitis, or NASH, candidate Selonsertib flunked in a late-stage study.

Stellar Trial's Dimmed Results

Gilead said the STELLAR-4 study that evaluated the safety and efficacy of Selonsertib in patients with compensated cirrhosis due to NASH did not achieve statistical significance with respect to the primary endpoint of achieving greater than or equal to one-stage histologic improvement without worsening of NASH at week 48.

Selonsertib is a once-daily, oral inhibitor of apoptosis signal-regulating kinase 1, or ASK1. The trial was designed as a randomized, double-blind, placebo-controlled study with 877 patients.

About 14.4 percent patients treated with 18mg Selonsertib and 12.5 percent patients treated with 6mg Selonsertib achieved the primary endpoint at week 48 compared to 12.8 percent patients receiving placebo.

"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, R&D Head at Gilead.

Way Forward

Gilead now looks ahead to another late-stage study dubbed STELLAR-3 of Selonsertin in patients with bridging fibrosis due to NASH and a mid-stage study dubbed ATLAS, which is evaluating a combination of Selonsertib, cilofexor and firsocostat in patients with advanced fibrosis, both due to NASH later this year.

Gilead shares were down 3.3 percent at $65.35 Tuesday morning.

Intercept Pharmaceuticals, Inc. (NASDAQ: ICPT), which is running neck-on-neck in the NASH drug development race, is trading about 2 percent higher at $119.56.

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