GENFIT INITATES PHASE I CLINICAL TRIALS OF GFT505, A MULTIMODAL MOLECULE DEDICATED TO THE PREVENTION AND TREATMENT OF SEVERAL RISK FACTORS OF CARDIOMETABOLIC DISEASE
Released on = September 19, 2006, 4:59 am
Press Release Author = Milestones for GENFIT
Industry = Biotech
Press Release Summary = GENFIT, the biopharmaceutical company engaged in the discovery and development of medical candidates in the areas of cardiovascular, inflammatory and metabolic diseases, today announced the entry into Phase I clinical trials of GFT505, the company's proprietary molecule for the simultaneous treatment of several risk factors of cardiometabolic disease.
Press Release Body = Lille (France), Cambridge (Massachusetts), 19th September 2006 - GENFIT, the biopharmaceutical company engaged in the discovery and development of medical candidates in the areas of cardiovascular, inflammatory and metabolic diseases, today announced the entry into Phase I clinical trials of GFT505, the company's proprietary molecule for the simultaneous treatment of several risk factors of cardiometabolic disease.
The mechanism of action of GFT505, a multimodal, pluripotent compound, acts on the molecular level by activating PPAR "Peroxisome Proliferator-Activated Receptors" nuclear receptors, which play a central role in the regulation of lipid metabolism and the control of glycemia. With a completely original profile (Pan-sPPARm, selective PPAR modulator, with a preferential action on the PPAR alpha family), and evaluated by Genfit's proprietary SNuRM technology platform, GFT505 targets a wide range of indications: mixed dyslipidemia (by raising levels of HDL- cholesterol and reducing those of triglycerides and LDL-cholesterol), type II diabetes (by controlling glycemia with an action on the energy metabolism of diabetic patients), and atherosclerosis (by reducing atheroma patches).
During preclinical tests, GFT505 demonstrated an extremely high margin of security and excellent absorption, whilst no significant unwanted side effect was observed, even at doses thirty to a hundred times higher than the active pharmacological dose.
The first Phase I clinical trial, the patients for which were recruited during the summer, aims to show that GFT505 is innocuous in healthy volunteers. The results of the Phase I trial are expected in the first half of 2007.
Dean Hum, Vice President and CSO, underlined, "During the International Symposium on Atherosclerosis in Rome in June this year, Genfit presented its strategy for the selection and modulation of nuclear receptors as therapeutic targets, a subject of enormous interest to leading international specialists in cardiovascular and metabolic diseases. GFT505 clearly subscribes to this approach and illustrates our capacity to select and develop multimodal molecules. GFT505 was developed to optimise the safety/efficiency ratio. The molecule finally emerged with an original profile demonstrating an optimal action on several risk factors of cardiometabolic illness.
Jean-François Mouney, Chairman and CEO, declared, "We are delighted that GFT505 has reached this new important stage in its development. This very promising molecule may provide an answer to huge medical needs, as yet unsatisfied by the hypolipemics and anti-diabetics already on the market or in development. GFT505 looks likely to initiate a pharmacological revolution in the prevention and treatment of cardiometabolic disease, which covers a series of disorders. We are confident that this program, in conjunction with other projects being developed in parallel on other therapeutic targets, will progress quickly in the next twelve months. With GFT14, which entered into Phase II clinical trials last May, GENFIT is pursuing its strategy of discovering pluripotent medicines destined to curb the pandemic of type II diabetes and associated cardiovascular risks."
About GENFIT
The emerging biopharmaceutical company, GENFIT studies gene deregulation, which is at the origin of some of the most wide-spread diseases. The GENFIT group identifies new therapeutic targets and develops drug candidates. The company\'s most advanced programs, conducted internally or in partnership with industry leaders such as SANOFI - AVENTIS, PIERRE FABRE, FOURNIER, MERCK AG, KOWA and SERVIER, concentrate on the treatment of key metabolic and inflammatory disorders. GENFIT's proprietary drugs focus on global cardiovascular risk by treating several pathologies, such as atherosclerosis, diabetes and obesity, simultaneously with a single molecule. Founded and managed by Professor Jean-Charles FRUCHART and Mr. Jean-François MOUNEY, the company is headquartered in Lille with facilities in Cambridge (USA). The company currently employs 120 people, including 90 scientists (www.genfit.com)