RESOLVE-IT Failure Dashes Genfit's NASH Hopes
Elafibranor Missed Trial Endpoints At The Interim Stage
Genfit SA is now pinning its hopes for elafibranor on primary biliary cholangitis after the dual PPAR alpha/delta agonist failed in its Phase III RESOLVE-IT trial for NASH.
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The company said a planned 9 June advisory committee to review the NDA for obeticholic acid in NASH has been postponed a second time, which means OCA likely will not be approved by 26 June.
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.