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Intercept’s Phase III Endpoints May Not Apply To Other Firms’ NASH Programs

Tobira’s cenicriviroc, which addresses both fibrosis and the inflammation underlying both NASH and fatty liver disease, could be approvable on a different set of parameters than Intercept’s OCA, the company says.

Other companies seeking to bring a drug therapy for non-alcoholic steatohepatitis to market were heartened by the news that Intercept Pharmaceuticals Inc. now has agreement with FDA on a Phase III trial design, but one NASH sponsor cautioned that what will apply to Intercept’s obeticholic acid (OCA) won’t necessarily pertain to other NASH candidates.

On May 19, Intercept revealed that after negotiations with FDA and the European Medicines Agency, it is planning a 2,500-patient...

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