Ipsen and Genfit present full Phase III data on elafibranor at AASLD

Ipsen (Euronext: IPN) and fellow French drugmaker Genfit (Euronext: GNFT) presented full results from the pivotal Phase III ELATIVE trial in a late-breaking oral session) at the American Association for the Study of Liver Diseases (AASLD) late yesterday.

The companies noted that this trial evaluated the efficacy and safety of investigational elafibranor, an oral, dual PPAR α,δ agonist, as a potential novel class of treatment for patients with the rare, autoimmune cholestatic liver disease, primary biliary cholangitis (PBC).

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 (P<0.001) between patients on elafibranor 80mg (51%) compared with patients on placebo (4%) achieving a biochemical response. In the trial, a biochemical response is defined as alkaline phosphatase (ALP) <1.67 x upper limit of normal (ULN), an ALP decrease ≥ 15% and total bilirubin (TB) ≤ 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.