Enanta dips on concerns about pruritus, differentiation of NASH compound
Dose selection for an upcoming trial could prove crucial among Enanta’s next steps for its FXR agonist following a Phase II readout in NASH that raised questions about the compound’s tolerability and differentiation from others in its class.
Enanta shed more than $200 million in market cap Thursday as investors digested data from the ARGON-1 study to treat non-alcoholic steatohepatitis, reported after the bell Wednesday. While the trial’s higher dose of Enanta’s EDP-305 met the its primary endpoint, data showed that dose also led to pruritus in 51% of patients, with a discontinuation rate of 20.8%. The rate was also higher than that seen with another compound in the same class, Ocaliva obeticholic acid from Intercept Pharmaceuticals Inc. (NASDAQ:ICPT), in the Phase II FLINT study. Intercept’s drug, the most advanced agonist of farnesoid X receptor (FXR; NR1H4), is nearing registration in the U.S. and EU...
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