GENFIT's GFT505 Granted FDA Fast Track Designation
By Cyndi Root
Genfit pharmaceutical company announced in a press release that the Food and Drug Administration (FDA) has given GFT505 Fast Track designation. GFT505 is indicated for Nonalcoholic Steatohepatitis (NASH). The expedited review is granted to drugs for serious diseases with unmet therapeutic needs. The drug’s sponsor receives priority in communicating with the FDA on study design and the drug discovery process. Chairman and Chief Executive Officer of Genfit Jean-François Mouney said, “All the preclinical and clinical data obtained to date show that GFT505 has the ideal profile for NASH treatment. The granting of the Fast Track designation will enable us to accelerate the development of GFT505 and reduce the time to market.”
Nonalcoholic Steatohepatitis
NASH is a liver disease that occurs in people with little to no alcohol use. The disease is sometimes called “silent” as many people are unaware that they have it until it shows up on routine blood panels. Liver damage can be severe, as the liver becomes fatty, inflamed, and sometimes cirrhotic. Cirrhosis makes the liver unable to function. While up to 20% of the American population have a “fatty liver” that is not harmful, up to 5% have NASH. It is diagnosed after a liver biopsy. The incidence of this disease is rising, in part due to the obesity epidemic. Obesity and its accompanying risks of heart disease and diabetes can negatively impact the patient’s ability to cope with NASH.
GFT505
GFT505 is in a class of compounds developed by Genfit. It targets NASH with a once-daily oral agent. Additionally, the drug positively influences other risk factors including inflammation, fibrosis, and insulin resistance. Efficacy and safety have been proven from several clinical trials. Diabetic patients have seen an improvement in the insulin resistance index, a reduction in fasting plasma glucose, and improvement in glucose homeostasis. The liver and surrounding tissues have shown an increase in insulin sensitivity. Atherogenic dyslipidemia has improved. Fibrinogen and haptoglobin have decreased, signifying GFT505’s anti-inflammatory properties. Researchers report a very good safety profile, with no adverse events reported.
GFT505-212-7 is being studied in a Phase IIb trial to study efficacy over one year.
The study is international in scope with over 50 centers participating in the U.S. and Europe. Results from this study of 270 people are due at the end of 2014.
Source:
http://genfit.com/fileadmin/press/press/press_release/2014.02.17_PR_GENFIT_GFT505_Fast_track.pdf