By Ted Bosworth
For treatment of non-alcoholic steatohepatitis, obeticholic acid (OCA) met one of its primary end points but not the other in the interim analysis of a phase 3 trial. The data provide proof that the drug is active, but not that the activity matters.
The results of the trial, called REGENERATE, are being followed closely. Obeticholic acid (Ocaliva, Intercept) could become the first drug with an indication for NASH. In REGENERATE, improvement in fibrosis by at least one stage was