Gilead stumbles in the race for a NASH treatment

Dec. 16, 2019

Gilead Sciences announced this week that its combination of experimental drugs all failed in a mid-stage study for non-alcoholic steatohepatitis (NASH).

There is currently no available treatment for NASH, a type of fatty liver disease related to obesity that impacts about 5 percent of the world’s population. Several pharma companies, including Intercept Pharmaceuticals and Novo Nordisk, have been racing for a slice of the potential pie in the NASH market that analysts predict could be worth $20 billion by 2025. 

Gilead’s latest study tried different combinations of three drugs: selonsertib, cilofexer and firsocostat. According to the company, none of the treatment combinations met the trial goals of improving fibrosis or building up scar tissue in the liver, without their NASH symptoms worsening. The trial results did not come as a surprise for Gilead’s NASH program, which has experienced several setbacks.

Intercept, meanwhile, is moving closer to regulatory approval for its NASH treatment. The company said this week that the FDA has set a tentative advisory committee date to review its treatment for April 20, 2020. Intercept has also filed a marketing approval application to the EMA.

Read the Reuters report.