GENFIT Announces Publication of Positive Results from the Phase 2 Clinical Trial Evaluating Elafibranor in Patients with PBC in the Journal of Hepatology

Lille, France; Cambridge, MA; February 09, 2021 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and liver diseases, today announced that the positive results from the Phase 2 clinical trial evaluating elafibranor in patients with Primary Biliary Cholangitis (PBC) with incomplete response to ursodeoxycholic acid (UDCA) have been published in the Journal of Hepatology.

Dr. Carol Addy, CMO at GENFIT, commented: “These data support the potential for elafibranor as novel treatment in PBC and confirm the rationale of evaluating our compound in this disease in a pivotal Phase 3 trial. PBC remains a disease with significant unmet medical needs, mostly because a substantial number of patients have insufficient response or cannot benefit from existing therapies. This publication reminds us that research can give patients and healthcare professionals hope for new therapeutic options. We seek to replicate the Phase 2 efficacy and safety results in ELATIVE, our Phase 3 clinical trial in PBC, in the hope that we may improve the prospect of new treatment for patients.”

These data show a clinically relevant improvement on the primary and composite biochemical endpoints, a positive trend on pruritus improvement, while maintaining a favorable tolerability profile, all of which are supportive of the conduct of ELATIVE, a longer term, larger scale pivotal Phase 3 study to evaluate elafibranor in patients with PBC.

Dr. Jörn Schattenberg, Director Metabolic Liver Research Program, University Medical Center, Mainz, Germany added: “These promising findings along with existing safety data derived from past clinical trials suggest elafibranor is a promising development candidate as a potential novel treatment for patients with PBC. Regulatory authorities know the disease well and there remains an important unmet need to be addressed as many patients at present remain without a long-term therapeutic option.”

Based upon the Phase 2 data, elafibranor was granted Breakthrough Therapy designation by the Food and Drug Administration (FDA), as well as Orphan Drug designation by the FDA and the European Medicines Agency (EMA).  In September 2020, GENFIT initiated enrollment of patients in ELATIVE, a global pivotal Phase 3 clinical trial to evaluate the efficacy and safety of elafibranor in patients with PBC and an inadequate response to UDCA. The randomized study (2:1, elafibranor: placebo) will evaluate approximately 150 patients following 52 weeks of treatment. Topline data are expected in Q1 2023.