GENFIT Initiates Phase II Clinical Trials With GFT14 To Tackle Cardiometabolic Risk

Main Category: Cardiovascular / Cardiology
Also Included In: Statins;  Diabetes;  Cholesterol
Article Date: 03 May 2006 - 0:00 PDT

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Phase I results revealed very good tolerance in healthy volunteers as well as an excellent security profile for GFT14, one of the medical candidates that GENFIT is developing to tackle cardiometabolic risk.

Lille (France), Cambridge (Massachusetts), 2 May 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 II clinical trials of GFT14, destined for the treatment of cardiometabolic risk.

The decision to commence Phase II was taken in light of the excellent results obtained during the Phase I. Initiated in March 2005, this test was carried out on over one hundred healthy volunteers who ingested GFT14 either in a single dose (50 - 500mg) or in a repeated dose over fourteen days (50 - 300 mg/day).

The results demonstrated that GFT14 attained all of its principal objectives; namely, that no significant adverse effect was registered during the course of the trials; that any reported adverse effect was weak, (and without the implication of the treatment being proven); that GFT14 is very well absorbed with pharmacokinetic parameters being perfectly compatible with a single daily dose. The trials in a healthy volunteer therefore concluded that GFT14 is very well tolerated.

"This first phase of clinical trials proved that the innovative formulation of GFT14 developed by GENFIT produced a very good margin of security", commented Professeur Fruchart, who continued : " Fresh from these promising results, an initial Phase II study targeting the effectiveness of GFT14 in patients with dyslipidemia has just been undertaken. The first patient should begin tests later this month, with results expected at the beginning of 2007".

GFT14, a proprietary compound from GENFIT, is destined to improve the condition of patients at risk from cardiovascular disease by a simultaneous and favorable action on the plasmatic lipids (rise of HDL- cholesterol et lowering of triglycerides) and on other risk factors such as hypertension or diabetes. Orally absorbed GFT14 has absolutely no structural link with current treatments for dyslipidemia (statin or fibrate based). The risks of medical interaction are weak and GFT14 may be easily combined with statins or other antidiabetic molecules (glitazones).

Dyslipidemic patients are defined as having a high level of "bad" cholesterol (LDL-C) and/or triglycerides and/or a low level of good cholesterol (HDL-C). They have, therefore, an increased risk of developing atherosclerosis, the clinical complications of which pose serious health problems, especially in cases of coronary implication.

Jean-François MOUNEY, Chairman and CEO of GENFIT declared:

" These highly promising results confirm the hypothesis that GFT14 constitutes, thanks to its novel pharmacological approach, a significant advance in the treatment of metabolic disorders. The results announced today illustrate our capacity to deliver innovative therapeutic solutions with huge potential and further reinforce the value of our product portfolio, currently comprising seventeen research programmes of which nine molecules are in development. Genfit is engaged in challenging the soaring global cardiometabolic pandemic characterized by obesity, diabetes and cardiovascular illness which are affecting an increasingly younger population."

About GENFIT
http://www.genfit.com

The emerging biopharmaceutical company, GENFIT (www.genfit.com) 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. Its most advanced programs, conducted internally or in partnership with industry leaders such as SANOFI - AVENTIS, PIERRE FABRE, SOLVAY - FOURNIER, MERCK AG, UCB, KOWA, SERVIER, concentrate on the treatment of key metabolic and inflammatory disorders. GENFIT's initial proprietary medicines will concentrate on global cardiovascular risk by treating several pathologies, such as atherosclerosis, diabetes and obesity, simultaneously with a single molecule. Founded and managed by Professeur Jean-Charles FRUCHART and Mr. Jean-François MOUNEY, the company is headquartered in Lille with facilities in Cambridge (USA). The company currently employs over 110 people.

http://www.genfit.com