Lille (France), Cambridge (Massachusetts, United States), July 7, 2009 – 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 announced important steps in the Phase IIa program aiming to demonstrate the therapeutic potential of its drug candidate GFT505, in prediabetic patients with multiple micro- and macrovascular risks.
Rémy Hanf, GENFIT’s Vice President of Product Development stated: ”We are pleased to see that all the patients of the study GFT505-2083 are now randomized and that the final results will be surely available by the end of November 2009. Furthermore, GENFIT has launched another pharmaco-clinical trial on prediabetic patients (GFT505-2084) designed to provide new information on the mechanism of action of GTF505 on glucose metabolism and inflammation. Together with the recent launch of the two-year studies in rodent species required by the regulatory agencies for a chronic treatment, these clinical trials comprise the key elements of the GFT505 development plan. In particular, these studies will ensure the design of the phase IIb dose-range-finding study and the choice of the comparator that should be used in the prediabetic patients for whom reducing global micro- and macrovascular risk remains a therapeutic need.”
About Phase II clinical study (GFT505-2084):
This new phase II pharmaco-clinical trial will include 40 prediabetic patients suffering from impaired fasting glucose and impaired glucose tolerance together with abdominal obesity. This randomized, double-blind vs placebo controlled trial will assess safety and efficacy of oral administration of 80mg/d GFT505 for 35 days on glucose metabolism and inflammation. The spectrum of activity will be assessed by measuring GFT505 induced changes in fasting plasma glucose, 2 hour plasma glucose after oral glucose tolerance test, HOMA, VO2max as well as numerous inflammatory markers. This multicentric trial is on-going in France with a patient evaluation period that will be completed at the end of November 2009 while the final results should be communicated two months later.
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, and 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, PIERRE FABRE, 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, respectively in partnership with SANOFI-AVENTIS (AVE0897) and SOLVAY (SLV341), are in the advanced stages of Phase I. With facilities in Lille, France, and Cambridge, MA (USA), the Company has about 130 employees, including over 100 scientists. GENFIT is a public company listed on the Alternext trading market by Euronext™ Paris (Alternext: ALGFT; ISIN: FR0004163111).
