Ipsen to move forward with elafibranor filings following data

French drugmakers Ipsen (Euronext: IPN) and Genfit (Euronext: IPN) have announced positive top-line data from the pivotal ELATIVE Phase III trial.

This study is assessing the efficacy and safety of elafibranor, an investigational dual α,δ PPAR agonist, to treat patients with the rare cholestatic liver disease, primary biliary cholangitis (PBC), who have an inadequate response or intolerance to the current standard of care therapy, ursodeoxycholic acid (UDCA).

"These are encouraging results that suggest elafibranor could be an effective treatment to prevent progression of PBC in patients who have received UDCA"The trial met its primary composite endpoint, with 51% of patients on elafibranor 80mg achieving a cholestasis response compared with 4% on placebo.