Elafibranor in PBC
Primary Biliary Cholangitis (PBC) is a chronic disease in which bile ducts in the liver are gradually destroyed.1 The damage to bile ducts can inhibit the liver’s ability to rid the body of toxins, and can lead to cirrhosis. Targeting PPAR receptors may result in a reduction of bile acid synthesis, improved detoxification of bile in the bile duct and anti-inflammatory activity. The use of drugs targeting PPAR receptors has been shown to reduce blood levels of Alkaline Phospahatase (ALP), and improve biochemical measures of cholestasis and pruritus (itching) in patients with PBC.
GENFIT is currently evaluating its proprietary drug candidate, elafibranor*, a dual agonist of PPARα and PPARδ in PBC. Enrollment is ongoing for the Phase 3 clinical trial ELATIVE™ (NCT04526665), which aims to confirm elafibranor 80mg efficacy, based upon changes in biochemical parameters and its potential to improve pruritus, and safety in patients with PBC.
In a multi-center, double-blind, randomized, placebo-controlled clinical Phase 2 trial (NCT03124108), the efficacy and safety of 12 weeks of elafibranor 80 mg, elafibranor 120 mg, or placebo were evaluated in patients with PBC and inadequate response to ursodeoxycholic acid (UDCA). The statistically significant efficacy and safety data from this study is supportive of proceeding with longer-duration, larger scale Phase 3 trials in patients with PBC.
Elafibranor was granted Breakthrough Therapy designation by the FDA in April 2019 for the treatment of PBC in adults with inadequate response to UDCA, as well as Orphan Drug Designation by the FDA and the EMA (European Medicines Agency) in July 2019.
We are committed to exploring the safety and efficacy of elafibranor in other potential therapeutic areas.