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GENFIT: Two major pre-diabetes clinical trials within the IT-Diab Program

Lille (France), Cambridge (Massachusetts, United States), May 31, 2010 – GENFIT (Alternext: ALGFT; ISIN: FR0004163111), a biopharmaceutical company at the forefront of drug discovery and development, focusing on the early diagnosis and preventive treatment of cardiometabolic and associated disorders, today announces that it has received approval from the French medical agencies to initiate the enrollment of patients in two major clinical trials in pre-diabetes and the early stages of diabetes, as part of its IT-Diab program.

The DECODIAB (DEpistage et COmpréhension du préDIABète) study, where a cohort of 500 hyperglycemic subjects will be assessed prospectively over a 5 year period for their conversion to Type 2 Diabetes, is led by Pr. Bertrand Cariou (Endocrinology-Diabetology Department, Thorax Institute/U915 INSERM, CHU Nantes, France). It will offer the opportunity to identify and validate in humans new biomarkers of -cell dysfunction in a population prone to develop Type 2 Diabetes. Enrollment for the DECODIAB trial is expected to begin in June 2010.

The ABOS (Atlas Biologique de l’Obésité Sévère) study, a clinical study initially designed by Pr. François Pattou (Head of the Endocrine General Surgery Department and of U859 INSERM, CHRU Lille, France) to analyze the association between glycemic or ponderal status and tissue gene expression, has been extended in the context of IT-Diab to provide longitudinal follow-up and samplings of a cohort of 900 morbid obese patients subjected to bariatric (weight loss) surgery. Enrollment for this trial is expected to begin in July 2010.

“The initiation of these large clinical trials that will assemble over 1000 patients represents a major step forward in the understanding of this disease, that will pave the way to the development of new medical strategies and drugs for the treatment of pre-diabetes and the prevention of Type 2 diabetes” said Jean-François Mouney, Chairman and CEO of GENFIT.

“The strong collaborations that GENFIT has established with world-renowned clinical experts such as Pr. Cariou and Pr. Pattou, and the privileged access to customized cohorts of various patient sub-populations in major hospitals, will provide us with precious phenotypic data and longitudinal biological samples. Combined with our cutting-edge analytical technologies, these human data sets represent an unprecedented source of information that we will exploit in our biomarker and target discovery programs to develop new diagnostic and therapeutic solutions for pre-diabetes and early stages of Type 2 diabetes” added Dr. Dean W. Hum, CSO of GENFIT.

About the IT-Diab Program:

IT-Diab (Therapeutic Innovation – Diabetes) is an industrial/academic research consortium comprising four companies with world-renowned scientific expertise, as well as seven internationally recognized academic members, of which Pr. Cariou and Pr. Pattou’s teams. The IT-Diab consortium totalizes a budget of €24.9 million and is supported by OSEO, the French SME’s funding agency. It is structured and managed by GENFIT and provides an innovative medical and technological approach addressing unmet medical needs in pre-diabetes and diabetes.

Organized around a large clinical investigation plan complemented by experimental translational approaches, the IT-Diab program primarily strives to decipher physiopathological mechanisms leading to insulin resistance and to pancreatic dysfunction. The ultimate goal is to develop new diagnostic and therapeutic solutions for pre-diabetes and early stages of Type 2 diabetes.

About GENFIT:

GENFIT is a biopharmaceutical company focused on the Discovery and Development of drug candidates in strategic therapeutic fields linked to cardiometabolic and neurodegenerative disorders (prediabetes/diabetes, atherosclerosis, dyslipidemia, obesity, Alzheimer’s…). GENFIT uses a multi-pronged approach based on early diagnosis, preventive solutions, and therapeutic treatments to address these major public health concerns and their unmet medical needs. GENFIT’s proprietary research programs and its partnerships with leading pharmaceutical companies, including SANOFI-AVENTIS, SOLVAY GROUP, and SERVIER, have resulted in the creation of a rich and diversified pipeline of drug candidates at different stages of development. GENFIT’s lead proprietary compound, GFT505, is currently in Phase II and two other compounds, in partnership with SANOFI-AVENTIS and SOLVAY, are in the advanced stages of Phase I.

With facilities in Lille, France, and Cambridge, MA (USA), the Company has approximately 120 employees. GENFIT is a public company listed on the Alternext trading market by Euronext™ Paris (Alternext: ALGFT; ISIN: FR0004163111). www.genfit.com

Contacts:

GENFIT
Jean-François Mouney – Chairman of the Management Board
+33 (0)3 2016 4000

MILESTONES – Press Relations
Bruno Arabian
+33 (0)1 75 44 87 40 / +33 (0)6 87 88 47 26 – barabian@milestones.fr

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