Genfit SA (GNFTF)

[Wildbilly]

FDA grants Fast Track designation to GFT505 in NASH

In February 2014

GFT505 is an oral treatment positioned as a best-in class drug to treat NASH.
Based on the beneficial activities that it demonstrates on the different features of the pathology, GFT505 represents the ideal drug for the patients including those suffering from the most severe forms of NASH.
Its therapeutic profile on a range of metabolic factors and fibrotic processes, together with its safety profile, widen the therapeutic potential of GFT505 to other non-hepatic pathologies and also present solid arguments for positioning this candidate in the prevention of cardiovascular events in prediabetic and diabetic patients.

An oral once-daily treatment, GFT505 is Genfit’s lead pipeline product currently in a US/EU phase 2b clinical trial for the treatment of NASH (Non-Alcoholic Steato-Hepatitis).
Administered to over 600 patients and healthy volunteers to date, GFT505 has demonstrated beneficial properties for NASH, including in particular:
Improvement of markers of liver dysfunction, including ALAT, ASAT, ?GT, ALP
Improvement of insulin sensitivity and glucose homeostasis
Favorable effects on plasma lipids, including decrease of plasma triglycerides and LDL-C, and increase of HDL-C levels.
Anti-inflammatory properties
Efficacy on histological NASH parameters (steatosis, inflammation, fibrosis) in animal disease models – anti-fibrotic activities
The absence of safety concern has been confirmed in a full toxicological package up to 2-year carcinogenicity studies.
Its pleiotropic beneficial anti-NASH activities, combined with its anti-fibrotic properties, position GFT505 as an attractive new generation drug candidate for treating NASH and eliminating the underlying causes of fibrosis, thus avoiding evolution to cirrhosis and its complications.

GFT505 is currently being tested for clinical efficacy in NASH in a 1-year liver biopsy-based Phase 2b trial (GFT505-2127), one of the largest interventional studies ever conducted in NASH. A total of 56 centers of clinical excellence in the United States and in multiple European countries (France, Belgium, The Netherlands, Italy, United Kingdom, Germany, Spain, and Romania) actively participate in this study initiated in October 2012. Two hundred and seventy-five (275) diabetic and non-diabetic patients are included in this study, divided into 3 groups treated with GFT505 at 80 or 120 mg/day, or with placebo.

In October 2013, the members of the independent Data Safety and Monitoring Board (DSMB), set up to ensure patient safety, analyzed the complete safety data for patients that had been treated for more than 6 months with GFT505 at 80 mg/day. The members of the DSMB unanimously concluded that GFT505 showed no safety issue that compromised the ongoing Phase 2b study. Therefore, the Phase 2b study continues to progress according to the planned protocol.


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