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Gilead’s FXR Agonist Posts Questionable Results In NASH, But Offers Hope In PSC

 
• By Joseph Haas

Although GS-9674’s efficacy data don’t appear as promising as that for Intercept’s competing FXR agonist OCA, Gilead seems to be building an argument that its drug has a better combination of efficacy and safety.

scientists doing lab research on digital screen

Gilead Sciences Inc. unveiled Phase II data for its farnesoid X receptor (FXR) agonist GS-9674 in non-alcoholic steatohepatitis (NASH) that raise doubts for its promise in that indication compared to other candidates from the same class, but Gilead’s drug fared better in a primary sclerosing cholangitis (PSC) trial, showing improvements in liver biochemistry and markers of cholestasis.

A competing NASH candidate, Intercept Pharmaceuticals Inc.'s obeticholic acid (OCA), showed the ability to reduce both fibrosis and steatosis in the Phase II FLINT trial, although increased lipid levels were seen in the same study. (Also see "Intercept Thinks Fibrosis Effect Could Carry Its NASH Candidate" - Pink Sheet, 17 November, 2014.) In Phase II data presented at the American Association for the Study of Liver Disease meeting Nov

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• By Andrew McConaghie

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