Enanta Stumbles In Trying To Show Better FXR Agonist Profile In NASH

Enanta Pharmaceuticals Inc. is one of at least six companies working to develop a farnesoid X receptor (FXR) agonist for non-alcoholic steatohepatitis that might offer a better overall risk/benefit profile than Intercept Pharmaceuticals Inc.’s obeticholic acid (OCA) – likely to be the first drug approved for NASH – but data from its Phase IIa ARGON-1 study don’t offer a conclusive case on efficacy or tolerability.

The Boston-based infectious disease specialist unveiled data on 25 September testing 2.5mg and 1mg doses of EDP-305 in NASH patients that hit a primary endpoint for ALT reduction at 12 weeks along with a secondary endpoint of liver fat reduction. But a high rate of pruritus and of patients exiting the study due to that adverse event has investors questioning the drug’s profile. Pruritus has also been an issue for Intercept’s drug