Thursday, May 10, 2012

GENFIT : GFT505 PROMOTES LIVER FIBROSIS REGRESSION

GENFIT : GFT505 PROMOTES LIVER FIBROSIS REGRESSION

* Reuters is not responsible for the content in this press release.


Thu May 10, 2012 11:45am EDT

GENFIT: GFT505 PROMOTES
LIVER FIBROSIS REGRESSION
  • New pre-clinical data show that the oral administration of GFT505 promotes elimination of established liver fibrosis. In parallel, the treatment leads to decreased markers of fibrosis and inflammation.
  • In humans, GFT505 is a candidate for the curative treatment of hepatitis associated liver fibrosis.
Lille (France), Cambridge (Massachusetts, United States), May 10th, 2012 - 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 associated disorders, today announces new pre-clinical data showing that the administration of GFT505 has a beneficial impact on the regression of liver fibrosis and decreases hepatic markers of inflammation and fibrosis, which are important components of NASH*.

Previous studies have demonstrated efficacy of GFT505 in preventing and blocking liver fibrosis in animal models. The present pre-clinical study further demonstrates the potential of GFT505 in reversing advanced liver fibrosis.

After having induced hepatic fibrosis in animals by the injection of a pro-fibrotic chemical agent (carbon tetrachloride, CCl4) for 2 weeks, the chemical stress was discontinued and groups were treated with GFT505 or vehicle control for up to 2 weeks. The microscopic examination of the liver demonstrates that GFT505 treatment significantly promotes clearance of fibrosis. Accordingly, liver gene expression markers of fibrosis and inflammation were dramatically decreased in the GFT505 treated group.

Commenting on these results, Dr.Rémy Hanf, EVP, Product Development, declared: « Together with previous animal studies demonstrating the potency of GFT505 to treat NASH, this complementary study shows that GFT505 is also able to promote regression of liver fibrosis strengthening the therapeutic potential of GFT505."

Further commenting these results, Dr. Sophie Megnien, CMO of GENFIT added: "In patients with chronic hepatitis, regression of fibrosis remains an unmet medical need. According to these data, GFT505 should have the ability to repair the damages caused by this pathology and might therefore widen its therapeutic area beyond NASH*".

*About NAFLD and NASH:In parallel with the current pandemic of diabetes and obesity, the prevalence of non-alcoholic fatty liver disease (NAFLD) is increasing considerably. NAFLD is believed to affect between 80 and 100% of diabetic patients, and progresses to non-alcoholic steatohepatitis (NASH) in 20-50% of cases. This serious liver disease can further progress to cirrhosis and liver cancer. There is currently no approved treatment for NAFLD/NASH, and the portfolio of products in the advanced stages of development is limited.

About GENFIT:
GENFIT is a biopharmaceutical company focused on the Discovery and Development of drug candidates in therapeutic fields linked to cardiometabolic disorders (prediabetes/diabetes, atherosclerosis, dyslipidemia, inflammatory diseases.). GENFIT uses a multi-pronged approach based on early diagnosis, preventive solutions, and therapeutic treatments and advances therapeutic research programs, either independently or in partnership with leading pharmaceutical companies, including Sanofi, to address these major public health concerns and their unmet medical needs.
GENFIT's research programs have resulted in the creation of a rich and diversified pipeline of drug candidates at different stages of development, including GENFIT's lead proprietary compound, GFT505, that is currently in Phase II.

With facilities in Lille, France, and Cambridge, MA (USA), the Company has approximately 100 employees. GENFIT is a public company listed on the Alternext trading market by Euronext(TM) Paris (Alternext: ALGFT; ISIN: FR0004163111). www.genfit.com

Contacts:

GENFIT
Jean-François Mouney - CEO & Chairman of the Management Board
+33 (0)3 2016 4000

Milestones - Press Relations
Bruno Arabian
+33 (0)1 75 44 87 40 / +33 (0)6 87 88 47 26 - barabian@milestones.fr
2012.05.10 PR GFT505 Fibrosis Regression

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