Searching For Surrogate Endpoints Requires Teamwork
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.
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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.
The pivotal REGENERATE study of Ocaliva now can succeed if either of two co-primary endpoints is achieved. Intercept also will use a new "objective" definition of NASH resolution in the study.
Lack of pruritus and a positive cardiometabolic profile could give elafibranor an advantage as it competes with Intercept’s Ocaliva to be the first drug therapy to market in NASH. The French biotech also is working on a biomarker algorithm to optimize patient selection.