The launch of the trial is based on the positive GFT505-209-4 and GFT505-109-6 studies, demonstrating the insulin-sensitizing effects of GFT505 in non-diabetic subjects.
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 proven beneficial effects on diabetic dyslipidemia and the pro-inflammatory state.
“Thus, if the safety and efficacy of GFT505 are confirmed, this Phase II trial should give the drug candidate a unique positioning in the management of type 2 diabetes through its wide spectrum of action, Cariou said.
Genfit vice president Product Development Remy Hanf the latest pre-clinical data further strengthen the anti-diabetic efficacy of GFT505, since they show highly significant beneficial effects of GFT505 on HbA1c, while shedding new light on its original mechanism of action.”