Ipsen, Genfit announce full results from pivotal Phase III ELATIVE trial

Ipsen (IPSEY) and Genfit (GNFT) announced full results from the pivotal Phase III ELATIVE trial, which are being presented in a late-breaking oral session at the American Association for the Study of Liver Diseases and simultaneously published in New England Journal of Medicine. This trial evaluated the efficacy and safety of investigational elafibranor, an oral, dual PPAR alpha,delta agonist, as a potential novel class of treatment for patients with the rare, autoimmune cholestatic liver disease, Primary Biliary Cholangitis. Results show statistically significant improvements in biomarkers of disease progression across key endpoints with a significant treatment benefit achieved in the primary composite endpoint, demonstrating a 47% placebo-adjusted difference between patients on elafibranor 80mg compared with patients on placebo achieving a biochemical response. In the trial, a biochemical response is defined as alkaline phosphatase less than1.67 x upper limit of normal, an ALP decrease greater than or equal to 15 percent and total bilirubin less than or equal to ULN at 52 weeks. ALP and bilirubin are important predictors of PBC disease progression. Reductions in levels of both can indicate reduced cholestatic injury and improved liver function.