Intermediate magnification micrograph of primary biliary cirrhosis. Credit: Nephron.

GENFIT has completed patient enrolment in a Phase lla trial to investigate the efficacy and safety of elafibranor for the treatment of patients with Primary Biliary Cholangitis (PBC) and inadequate response to ursodeoxycholic acid.

The multicentre, double-blind, randomised, placebo-controlled trial enrolled 45 patients, some of whom have already completed the trial’s 12-week treatment period.

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The trial includes three arms to provide 80mg and 120mg of elafibranor, and placebo. Each arm of the study comprises 15 patients.

It is being conducted at several clinical centres in the US and Europe.

The trial’s primary goal is to determine the effect of daily oral administration of elafibranor on serum alkaline phosphatase (ALP) in the enrolled patients.

Its secondary endpoints comprise safety and tolerability of elafibranor, particularly on pruritus, and quality of life.

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“This attribute, along with what PPAR agonists have demonstrated on ALP reduction, provides a strong rationale for elafibranor in PBC.”

Top line data from the trial is scheduled to be unveiled by the end of this year.

Sophie Mégnien, Chief Medical Officer of GENFIT, added: “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 consistently in previous clinical studies, on other populations.

“This attribute, along with what PPAR agonists have demonstrated on ALP reduction, provides a strong rationale for elafibranor in PBC.

“Recent clinical data has shown that PPAR alpha may also have a positive impact on pruritus, which further differentiates the dual mechanistic action of elafibranor to not only improve liver biochemistry (delta) but also alleviate pruritus (alpha) in this rare disease.”

PBC is a rare autoimmune disease that occurs due to the gradual damage of bile ducts in the liver, which could result in cirrhosis and even liver failure.