Genfit Shows Encouraging Results in GFT505 First Clinical Trial of Efficacy

LILLE (France), CAMBRIDGE (Mass.), March 27, 2008 – GENFIT (Alternext: ALGFT; ISIN: FR0004163111) the biopharmaceutical company at the forefront of research and development of cardiovascular, inflammatory and metabolic drugs today announced encouraging clinical results for activity and tolerance of GFT505 in patients presenting mixed dyslipidemia of type 2b (Triglycerides > 200 mg/dL and LDL-C<130 mg>This phase 2a pilot study was carried out in double-blind vs placebo with a limited number of patients treated over 28 days with 30 mg/day GFT505 (n=24) or with the placebo (n=13). The aim was to gather data concerning the therapeutic potential and the tolerance of this new mixed agonist for PPAR receptors, and to better define the design of the phase 2a trial including appropriate dosage. Effectiveness was measured relative to a group of cardiovascular risk factors

Despite the small number of patients, which limits the statistical power of the trial, the dose of 30 mg/day of GFT505 shows a very broad profile of activity. In particular, GFT505 reduces the levels of triglycerides, non- HDLC and remanent particles. Additionally, a parallel reduction of levels of Apo-CIII, ApoB and ApoE particles, as well as, the levels of ApoCIII-nonApoB, ApoCIII-ApoB, ApoE-ApoB, and ApoE-nonB particles were observed

Compared to the placebo patients, those of the GFT505 group showed an increase in their levels of ApoA1 and ApoA2 HDL-C. Finally, a reduction in fibrinogen level of patients was observed. Complementary analyses are underway seeking to clarify the acting mechanism of GFT505. Product tolerance was excellent as no secondary effect emerged nor was reported that could be imputed to the treatment in the GFT505 group

Following this first trial, GENFIT has decided to pursue the development of GFT505 for treatment of dyslipidemia and reduction of risk of micro- and macro-vascular ailments associated with metabolic syndrome

Considering the potential for activity of this new drug candidate compared to GFT14 (GENFIT’s first compound) on the same target population, the Company’s assessment favors GFT505, and future development efforts will be concentrated on this product

Jean-François Mouney, Chairman of GENFIT’s Management Board: “Based on these encouraging results, GENFIT has decided with an immediate action to accelerate the development of GFT505, at the expense of the GFT14 program. During this first trial, GFT505 has demonstrated a significantly better clinical activity on the lipid triad. As the next step, we need to confirm the potential of this drug candidate originating from our technological platform of Selective Nuclear Receptor Modulator (SNuRM). GFT505 represents our most successful compound in a new class of drug candidates, dedicated to the prevention of global cardiometabolic risk factors. The additional clinical trials of GFT505 will enable us to provide the pharmaceutical industry a major therapeutic option in an area of unmet need”

About GFT505: GFT505 is the most advanced compound of a new generation of drug candidates developed by GENFIT that aims at the global prevention of cardiometabolic risk factors. This drug candidate stems from the Selective Nuclear Receptor Modulator (SNuRM) platform developed by GENFIT, for the identification of innovative drug candidates with improved efficacy and safety profiles compared to current treatments. With a novel mechanism of action, GFT505 is a pluripotent compound acting simultaneously on different risk factors associated with obesity: the lipid triad (increasing of HDL cholesterol, lowering of triglycerides and LDL cholesterol), insulinresistance and diabetes, atherosclerosis and inflammation in animal models. This molecule has demonstrated neuro-protective effects in an ischemia-reperfusion model of stroke, and it may potentially have effects in neurodegenerative diseases (such as Alzheimer and Parkinson diseases).

About Dyslipidemia: Dyslipidemia is thought to affect between 4 and 10% of the world population. It plays a key role in cardiovascular disease. In 99% of the cases, dyslipidemia is responsible for atherosclerosis. The lipids are indeed atherogenes, and they can settle on the wall of the arteries and form multiple atheromatous plaques

Atherosclerosis involves both the thickening of the walls of the large arteries (abdominal aorta, coronary arteries, cerebral arteries, leg arteries) and their blockage by atheromatous plaques. The progressive blockage of the arteries diminishes the supply of blood and oxygen to the tissues. The arteries most affected by atherosclerosis are the coronary arteries, feeding the heart, which leads to coronary insufficiency. Complete blockage of the coronary arteries, depriving the heart of oxygen, is responsible for myocardial infarction

Approximately, 80% of victims of myocardial infarction have a disorder of the blood lipids. Type IIb mixed dyslipidemia is the most common. This is characterized by an increase in bad cholesterol (LDL-C) and of triglycerides (VLDL-TG)

About GENFIT: A biopharmaceutical company, GENFIT studies the deregulation of genes implicated in many of the most widespread diseases. GENFIT’s scientists identify new therapeutic targets and develop drug candidates designed specifically for such targets. GENFIT’s programs, conducted in partnership with pharmaceutical companies such as SANOFI-AVENTIS, SOLVAY GROUP, PIERRE FABRE, MERCK AG, and SERVIER, treat the most prevalent metabolic and inflammatory diseases. GENFIT’s development of proprietary drugs focuses on global cardiovascular risk factors, using a single molecule to simultaneously attack several pathologies (atherosclerosis, diabetes, obesity, etc.). GENFIT possesses a rich and diversified pipeline of drug candidates in all stages of development – development carried out by GENFIT alone or in partnership. GENFIT’s lead proprietary compound, GFT505, is currently in Phase II and another compound in partnership with SANOFIAVENTIS (AVE0897) is now completing Phase I. With facilities in Lille, France, and Cambridge, MA (USA), the company has over 130 employees on staff, including over 100 scientists. GENFIT is a public company listed on the Alternext by Euronext™ Paris (Alternext: ALGFT; ISIN: FR0004163111)

Posted: March 2008

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