Date: 2011-07-12
Type of information: Results
phase: 2a
Announcement: results
Company: Genfit (France)
Product: GFT505
Action mechanism: PPAR agonist. Elafibranor (GFT505) is an oral once-daily treatment, and a first-in-class drug acting via dual peroxisome proliferator-activated alpha/delta pathways to treat nonalcoholic steatohepatitis (NASH).
Disease:
Therapeutic area: Metabolic diseases - Cardiovascular diseases
Country:
Trial details:
Latest
news: Genfit has announced the first results of the GFT505-210-5 clinical trial, confirming the broad spectrum of action of GFT505 in diabetic patients. A scientific committee of independent international experts has studied the results and strongly encouraged Genfit to pursue the development of GFT505 for two indications: NAFLD/NASH (nonalcoholic hepatic steatosis and fibrosis) and the prevention of cardiovascular risk in diabetic patients.
The GFT505-210-5 Phase II trial, that studied the effect of 12 weeks of GFT505 treatment versus placebo in 97 treatment-naïve diabetic patients, is part of Genfit’s program for the evaluation of the therapeutic potential of GFT505 in different target populations. These first results confirm and reinforce the multifaceted activity of GFT505 on several metabolic parameters:
In the GFT505-treated group, glucose homeostasis is improved. Compared to baseline values, there is a significant reduction in HbA1c levels (-0.4%, p=0.01), in 2 hour glycemia upon OGTT (-38 mg/dL ; p<0.001), and in the area under the curve for glycemia upon OGTT (-39 mg/dL*h ; p<0.001). There is also a reduction in fasting glycemia in the GFT505 group (-8.01 mg/dL, p=0.08), while this parameter is not altered in the placebo group. A non-significant improvement observed for the other glycemic parameters of the placebo group limits inter-group statistical significance.
GFT505 treatment strongly lowers plasma triglyceride levels (-34% vs placebo, p<0.0001). It also significantly lowers non-HDL-C (-12%, p<0.001), LDL-C (-8%, p<0.05), and total cholesterol (-8%, p<0.01). The level of HDL-C is increased by +15% (p<0.0001) compared to baseline values, but a significant effect is also observed in the placebo group (+11%, p<0.01).
Markers of hepatic dysfunction are improved upon GFT505 treatment, with a highly significant reduction in gamma GT levels (-28% vs placebo, p<0.0001). Moreover, the excellent safety profile of GFT505 is confirmed over a prolonged period of 3 months. GFT505 has no undesirable effect on arterial pressure or cardiac rhythm, and no weight gain, edema, or hemodilution were observed.
Pr. Bertrand Cariou, Principal Investigator of the study declared: « Based on the results of the different studies conducted by GENFIT, the scientific expert committee strongly recommended continuing the clinical development of GFT505 and the initiation of a Phase IIb trial. This next study, that will pave the way for Phase III, will enable the confirmation of the beneficial properties of GFT505 in cardiovascular prevention and its positive effects in NAFLD/NASH. This study will target a high risk population, including diabetics, pre?diabetics, and patients with the metabolic syndrome ».
