Intercept quiet on NASH safety data disclosure concerns
This article was originally published in Scrip
Intercept Pharmaceuticals is not commenting on reports that the company did not appropriately disclose safety information about its lead drug candidate obeticholic acid (OCA), but Intercept released a set of e-mail messages on 22 May that show the company knew about OCA's impacts on cholesterol in the investigator-sponsored FLINT trial as early as 6 January.
You may also be interested in...
After otherwise successful Phase II NASH trial showed Ocaliva can increase a patient's LDL cholesterol levels, Intercept hopes a study in NASH patients who use atorvastatin will show this effect is manageable.
As Gilead’s ASK1 inhibitor nears Phase III, Intercept may be plagued by slower-than-expected enrollment of its Phase III trial for Ocaliva. A recent Biomedtracker survey finds liver docs may be more positively inclined toward the Gilead candidate.
The Medicines Company, Amarin and Geron have all reported interim analyses for clinical studies recently and investors have been left disappointed. Were we better off without the interim analysis?