Genfit gets FDA’s IND clearance for PBC drug to go on with phase 2 study

Genfit, a biopharmaceutical company has gotten the FDA’s clearance for the IND to proceed with the Phase II trial aimed at evaluating elafibranor in Primary Biliary Cholangitis PBC.

As previously announced, this trial is designed to be a multicenter, double-blind, randomized, placebo-controlled, Phase II study to evaluate the efficacy and safety of elafibranor after 12 weeks of treatment in patients with PBC and inadequate response to ursodeoxycholic acid.

The primary objective is to determine the effect of daily oral administration of elafibranor on serum alkaline phosphatase (ALP) in these patients, based on relative change versus placebo.

PBC is a chronic disease in which bile ducts in the liver are gradually destroyed. The damage to bile ducts can inhibit the liver`s ability to rid the body of toxins, and can lead to scarring of liver tissue known as cirrhosis.

PBC is a rare disease with unmet need. Current treatments only cure a fraction of the patient population, and/or generate important side effects such as pruritus, which is a major and well-known symptom already affecting most PBC patients.

Jean-François Mouney, CEO, Co-founder, and Chairman of the board of Genfit commented: “We are satisfied with the progress made on the regulatory side in PBC. Our presence in this field is highly relevant given the profile of elafibranor, our proprietary molecule. We soon hope to be able to provide patients with a new, safe and well-tolerated therapeutic solution. Our involvement in PBC will continue to enrich our medical network thanks to our broad discussions and interactions we have with hepatologists. We value and cultivate a high level of collaboration with the medical community as it`s a way for us to ensure that the best decisions are made to address unmet medical needs in this field.”