French biotech firm Genfit (Alternext: ALGFT) says that its leading drug candidate GFT505 in a Phase II clinical study dubbed GFT505-210-6 has reached all its primary and secondary efficacy objectives with no adverse side effects.
Statistical analysis shows that GFT505 improves insulin sensitivity in the liver and peripheral tissues, improves dyslipidemia, and lowers markers of liver dysfunction and inflammation in insulin-resistant patients with abdominal obesity (BMI = 30±3 kg/m2).
The primary objective of the GFT505-210-6 pharmaco-clinical trial was to evaluate the effect of eight weeks of GFT505 treatment (80mg/day) on the insulin sensitivity of the liver and peripheral tissues by the gold standard hyperinsulinemic euglycemic clamp technique. The decrease in hepatic glucose production (HGP) induced by insulin was -0.86 ± 0.07mg/kg/min after GFT505 versus -0.63 ± 0.07 mg/kg/min after placebo (p=0.006), equivalent to an improvement in the liver insulin response of 37%. Similarly, the insulin sensitivity of the peripheral tissues was significantly increased by GFT505 treatment (glucose infusion rate GIR, 3.8 ± 0.3 mg/kg/min after GFT505 vs 3.2 ± 0.3 mg/kg/min after placebo, p=0.019).
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