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.
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Genfit believes elafibranor’s clean tolerability and safety profile may help narrow the gap between it and Intercept’s OCA, with safety questions delaying OCA’s entry to market. Part two of Scrip’s interview with Genfit’s CEO and COO.
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.
Sponsors in the hotly pursued and yet untapped field of non-alcoholic steatohepatitis think that selection of different primary or co-primary endpoints could help differentiate their programs in the competitive space.