Intercept Liver Disease Strategy Bets Heavily On New Surrogate Endpoints
Intercept is aiming to file obeticholic acid for accelerated approval in two liver disease indications and is mining clinical outcomes data to support new surrogate endpoints with the help of a clinical network dubbed the “Supergroup.”
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Company is moving its galectin-3 inhibitor into Phase III in non-alcoholic steatohepatitis patients with cirrhosis – a very advanced disease setting – and also to validate endpoints that don’t require liver biopsy.
Discussions between FDA and researchers during a workshop on the fatty liver conditions NAFLD/NASH clarified the status of potential surrogate endpoints for clinical trials, but indicated that much work remains to be done to ready the various options for use – and that will likely need to be a joint effort.
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.