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news.Genfit, a biopharmaceutical company at the forefront of drug discovery and development, has initiated a new Phase II clinical trial to assess the HbA1c-lowering potential of a 12-week treatment with GFT505 at 80mg/d in type 2 diabetic patients.
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In the GFT505-209-4 and GFT505-109-6 studies, GFT505 showed insulin-sensitising effects in non-diabetic subjects.
An international expert panel chaired by Bart Staels, president of the Scientific Advisory Board, encouraged Genfit to launch a new clinical trial to assess the anti-diabetic efficacy of GFT505 in patients with HbA1c levels between 7.0 and 9.5% at inclusion.
The placebo-controlled study (GFT505-210-5) carried out in 6 European countries will include a total of 120 patients (2×60) and the results are expected to be available by mid-2011.
International Scientific Coordinator of the trial Bertrand Cariou said that all the clinical data obtained to date suggest that GFT505 should be efficacious in reducing fasting glycemia and HbA1c in type 2 diabetic patients in addition to its beneficial effects on diabetic dyslipidemia and the pro-inflammatory state.
Genfit Product Development vice president Remy Hanf said that the scientific experts are unanimous in acknowledging the intrinsic medical value of GFT505 in the treatment of type 2 diabetes.
“Their opinion is primarily based on the proof of efficacy in humans, but also on experimental results obtained in diabetic animals,” Hanf said.
“Indeed, the latest pre-clinical data further strengthen the anti-diabetic efficacy of GFT505, since they show beneficial effects of GFT505 on HbA1c, while shedding new light on its original mechanism of action.”