GENFIT to Begin Elafibranor Clinical Program in PBC

GENFIT

today announced at the GENFIT R&D Event in New York City, that the Company plans to begin a second Elafibranor clinical program in 2016, targeting unmet need in the liver disease Primary Biliary Cholangitis (PBC). GENFIT intends to begin a Phase 2 clinical trial of Elafibranor in the treatment of PBC before the end of 2016, in patients that do not tolerate or do not respond sufficiently to the standard primary treatment, with ursodeoxycholic acid (UDCA), which may occur in approximately 70% of patients. The Company will work with regulatory agencies to confirm the most appropriate trial endpoints and study design in the coming months. GENFIT also announced its intention to launch new trials in NASH for pediatric as well as cirrhosis subpopulations. In addition, the Company provided an overview of other research programs currently in progress and/or planned. Professor Velimir A. C. Luketic, MD, Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University School of Medicine, Richmond, VA, USA commented: "PBC is a rare disease that can adversely affect patients' quality of life and survival. Since the currently approved treatment has been associated with side-effects and is ineffective in a significant proportion of patients, there is a major need for newer therapies with an improved profile." Jean-François Mouney, Chairman and Chief Executive Officer of GENFIT said: "Based upon the known mechanistic effect of PPAR alpha on bile acid metabolism, as well as positive effects seen on surrogate markers in Elafibranor clinical studies, we have decided after discussions with KOLs and Primary Biliary Cholangitis experts that PBC is the next logical target in our development plan. When it comes to NASH, we are happy to expand our investigational studies with Elafibranor, and we are confident on the drug's ability to address further unmet needs." Dean Hum, Chief Scientific Officer (CSO) of GENFIT commented: "It was useful to share an updated overview on our pipeline today, because the work currently done by our teams in the field of gastroenterology and liver diseases is important for the future of GENFIT. NASH and Elafibranor have indeed had so much exposure recently that there have been few opportunities to shed light on other research work, and related achievements. It was therefore important for us to explain the diversity of our pipeline and provide insights on our global research strategy."