French biopharmaceutical company Genfit has begun patient enrolment for the Phase IIa clinical trial of elafibranor to treat primary biliary cholangitis (PBC).
Elafibranor is an oral once-daily that acts through proliferator-activated alpha / delta pathways.
Specifically developed for non-alcoholic steatohepatitis (NASH), the drug is expected to work on different aspects of the disease such as inflammation, insulin sensitivity, lipid / metabolic profile, and liver markers.
The multi-centre, double-blind, randomised, placebo-controlled Phase IIa trial is designed to recruit a total of 45 patients.
Set to be conducted at sites in the US and three European countries, the trial will assess the efficacy and safety of 80mg or 120mg of elafibranor for a period of 12 weeks in adult patients who have shown inadequate response to ursodeoxycholic acid (UDCA).
Genfit chief medical officer Sophie Mégnien said: “We are excited to have this first randomised PBC patient in this Phase II trial and advance our PBC programme.
Elafibranor, a dual PPAR alpha and delta agonist, is an attractive candidate for PBC patients due to its impact on lowering alkaline phosphatase levels, as shown in previous studies in other populations.
"This attribute, along with what PPARs have consistently demonstrated on ALP reduction, provides a strong rationale for elafibranor in PBC."
The trial's primary objective is determination of elafibranor's effect on serum alkaline phosphatase (ALP), while secondary objectives include safety, measure of total bilirubin, PBC scores, pruritus and quality of life.