Two Phase II Clinical Trials For Proprietary Drug Candidate GFT505, Aiming At The Global Treatment Of The Cardiometabolic Disease

Main Category: Cardiovascular / Cardiology
Also Included In: Pharma Industry / Biotech Industry;  Clinical Trials / Drug Trials
Article Date: 05 Oct 2007 - 4:00 PDT

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GENFIT (Alternext: ALGFT; ISIN: FR0004163111), a biopharmaceutical company committed to drug discovery and development in the field of metabolic, inflammatory and cardiovascular diseases, announced the beginning of two Phase II clinical trials for its proprietary drug candidate GFT505 aimed at the global treatment of cardiometabolic disease risk factors.

These two Phase II clinical trials are double blind, placebo-controlled and randomized. They aim to assess the safety and efficacy of once-a-day administration of a 30mg oral dose of GFT505 for 28 days. They are conducted in several clinical centers.

In the first Phase II study, the primary objectives are to evaluate the efficacy and the tolerability of GFT505 in patients with type IIb dyslipidemia.

In the second Phase II study, the primary objectives are to evaluate the efficacy and the tolerability of GFT505 in pre-diabetic patients with atherogenic dyslipidemia and abdominal obesity.

The results of the two Phase II clinical trials are expected in March and June 2008.

«The promising results of the Phase I clinical trial revealed a highly satisfactory safety margin. This drug candidate demonstrated in animal models significant positive effects on triglycerides, insulinresistance, HDL cholesterol and the prevention and stabilization of the atherosclerotic plaque confirming the pluripotent nature of GFT505. We are very enthusiastic to begin this new step in the development of GFT505, especially now that the scientific international community acknowledges the central role of Peroxisome Proliferator-Activated Receptors (PPAR nuclear receptors) in the mechanisms of regulation of lipid and glucose metabolism », explained Professor Jean-Charles Fruchart, Chairman of GENFIT's Supervisory Board and President of the International Atherosclerosis Society (IAS).

The GFT505 mechanism of action triggers PPAR nuclear receptors. GFT505 is endowed with a totally novel profile: it is a pan-SPPARM (Selective PPAR Modulator alpha, gamma, delta) with preferential activity on PPAR alpha.

GFT505 is the most advanced molecule of a new generation of drug candidates developed by GENFIT, which aim at the prevention of the global cardiometabolic risk. Stemming from the Selective Nuclear Receptor Modulator (SNuRM) platform developed by GENFIT, this new generation of drug candidates has a sophisticated mechanism of action. These compounds are able to differentially recruit cofactors to the nuclear receptor, which subsequently leads to differential regulation of genes and biological effect. Therefore, the ability to identify and profile the activity of SNuRMs is a powerful approach to select innovative drug candidates with improved efficacy and less side effects.These pluripotent and multimodal molecules have significant positive effects on obesity, insulin-resistance and diabetes, atherosclerosis and inflammation and the lipid triad (increasing of HDL cholesterol, lowering of triglycerides and LDL cholesterol). These molecules also revealed neuro-protective effects in ischemia models and may therefore be used to prevent and treat neuro-degenerative diseases (such as Alzheimer and Parkinson diseases).

Jean-François Mouney, Chairman of GENFIT's Management Board: « GFT505 offers significant competitive advantages compared to existing marketed drugs. This drug candidate, discovered and developed by GENFIT, for which we own all the intellectual property rights, is the first drug candidate stemming from our SNuRM platform. Designed with the best of our know-how, it prefigures what will soon come out of our more early-stage programs. GENFIT is massively investing in such programs in order to be in a position to out-license to Pharmaceutical companies new drug candidates that will safely and fully address colossal unmet patient needs.

About GENFIT

An emerging biopharmaceutical company, GENFIT studies the deregulation of genes implicated in 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 industrial pharmaceutical companies such as SANOFI-AVENTIS, PIERRE FABRE, FOURNIER (SOLVAY Group), MERCK AG, SERVIER, deal with the most prevalent metabolic and inflammatory diseases. GENFIT's internal drug discovery and development focuses on global cardiometabolic risks, attacking several pathologies (atherosclerosis, diabetes, obesity, etc.) simultaneously, using a multimodal approach to identify single molecules addressing multiples indications.

GENFIT possesses a rich and diversified pipeline of drug candidates in all stages of development, carried out by GENFIT alone or in partnership. Four molecules are in Phase II: 2 proprietary products and 2 molecules in partnership with Sanofi-Aventis (AVE8134 and AVE0847). In addition, another molecule in partnership with Sanofi-Aventis (AVE0897) is completing Phase I.

With facilities in Lille, France, and Cambridge (USA), the Company was founded by Jean-François MOUNEY, Chairman of the Management Board, with the scientific support of Jean-Charles FRUCHART, Chairman of the Supervisory Board. As of September of 2007, its staff was comprised of 130 employees, including more than 100 scientists. Genfit is a public company listed on the Alternext of EuronextTM Paris.

Warning: This press release expressly contains, in an implicit manner, certain prospective statements concerning GENFIT and its activity. These statements rely on certain risks, known or unknown, uncertainty or on other factors that may lead to actual results, financial conditions, performance or achievements on the part of GENFIT that may differ significantly from the results, financial conditions, performance or achievements expressed or implied in these prospective statements. GENFIT is issuing this press release on the present date and is not committed to update the prospective statements contained therein, either as a result of new information, future events or other. For a description of the risks or uncertainty of a nature to cause a difference between GENFIT's actual results, financial conditions, performance or achievements and those contained in the prospective statements, please refer to the section on "Risk Factors'' on the Prospectus available on the GENFIT website: http://www.genfit.com