GENFIT's GFT505 exhibits potential to address unmet needs in prediabetic and diabetic patients

Jan 28 2010

NEW CLINICAL EFFICACY RESULTS DEMONSTRATE THAT GFT505:

• REDUCES GLOBAL CARDIOVASCULAR RISK FACTORS IN PREDIABETIC PATIENTS WITH IMPAIRED GLUCOSE TOLERANCE
• DECREASES FASTING GLUCOSE LEVELS AND IMPROVES INSULIN SENSITIVITY
• HAS A POSITIVE IMPACT ON LIPID PARAMETERS (TRIGLYCERIDES AND CHOLESTEROL)
• HAS ANTI-INFLAMMATORY EFFECTS

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 neurodegenerative diseases, today announces positive results from a recently completed clinical trial demonstrating the activity of GFT505 on glucose homeostasis. Results from the clinical trial (GFT505-2094) clearly demonstrate the potential of the drug candidate to reduce global cardiovascular risk in prediabetic patients who suffer from impaired fasting plasma glucose, impaired glucose tolerance, and abdominal obesity.

Following treatment with GFT505 (80mg/day) for 28-days, the main objective of the study which was demonstration of efficacy of the compound on glucose homeostasis was attained. GFT505 led to a significant reduction in fasting plasma glucose levels in the treated group in comparison to the placebo treated group (-5% vs placebo,>

In addition to the effects of GFT505 on glucose homeostasis and parallel to results from the previous study (GFT505-2083), the new results from the GFT505-2094 study clearly reaffirm the beneficial effects of the compound on plasma lipids and demonstrate an additional effect on LDL-C. Patients treated with GFT505 had a significant reduction of bad cholesterol (LDL-C, -11% vs placebo,>

Taken together, the effects of GFT505 on plasma glucose, lipids, and inflammation, are expected to strongly reduce the risk of macrovascular events and microvascular complications found in prediabetic patients. The present study also confirms the favorable efficacy/safety ratio of GFT505, considering that no specific side effects were observed between the treated and placebo groups. In particular, treatment with GFT505, in contrast to fenofibrate, did not increase the level of circulating homocysteine which is considered a marker of cardiovascular risk.

Jean-François Mouney, CEO of GENFIT, stated: “Together with the results from the GFT505-2083 trial communicated in December 2009, the results of the present study demonstrate the strong potential of GFT505 as a therapy to address the existing unmet needs in prediabetic and diabetic patients. An extremely important point about GFT505 is obtaining the therapeutic effects without any identifiable undesirable side effects. Therefore, we consider the efficacy/safety profile of GFT505 unparalleled in this indication, in comparison to products on the market, as well as, to those under development. Of course, these results reinforce our conviction to be able to partner this program with a major pharmaceutical company to further advance the clinical development into Phase IIb and ultimately completion of Phase III studies and the marketing of GFT505.”

Dr. Dean W. Hum, CSO and Dr. Rémy Hanf, Vice-president of product development at GENFIT, added: “The Phase IIa program with the objective to provide proof of efficacy of GFT505 is now complete. The effect of the compound on glucose homeostasis is of course very important considering that it clearly differentiates GFT505 from its competitors. Following our complete analysis of the present study and in combination with the data from previous studies, Genfit will design the pivotal phase IIb study to optimize the future development plan of GFT505. Genfit is assembling a dedicated Steering Committee presided by Professor Bart Staels to oversee the advancement of GFT505. This committee will be composed of experts in the field and is scheduled to meet during the first quarter of 2010. In light of the recent results, several internationally renowned experts have already accepted to participate in this committee and to guide the development of GFT505.”