French biopharmaceutical firm Poxel has reported positive top-line results from its Phase IIb clinical trial of imeglimin in Japan to treat patients with type 2 diabetes.
Imeglimin is a first-in-class clinical candidate being developed to target mitochondrial bioenergetics of the liver, muscle and the pancreas.
The potential of the drug to lower glucose and prevent endothelial dysfunction is expected to offer protective effects on the micro-vascular and macro-vascular defects caused by diabetes.
The results from the randomised, double-blind, placebo-controlled Phase IIb trial showed dose-dependent efficacy and statistical significance for the primary endpoint of glycated haemoglobin A1c reduction.
Conducted in a total of 299 Japanese patients, the trial evaluated 500mg, 1,000mg and 1,500mg of imeglimin twice-daily over a period of 24 weeks.
It was observed that the decrease in haemoglobin A1c was prominent in Japanese patients compared to the US and EU patients.
The statistical significance for the trial's secondary endpoint of a decrease in fasting plasma glucose (FPG) was achieved by 1,000mg and 1,500mg doses.
The safety and the adverse event profile of imeglimin were found to be consistent with the data from the previous trials conducted in the US and EU.
Poxel early development and translational medicine executive vice-president Pascale Fouqueray said: “Imeglimin has been successfully studied in over 1,200 subjects and has shown a differentiated product profile combined with favourable safety, and we believe that it has the potential to address the large and growing needs of the type 2 diabetes market.”
The firm is planning to initiate imeglimin's Phase III programme in Japan, which will include three clinical trials with specific patient populations.
Poxel chief executive officer Thomas Kuhn said: "In Japan, we believe imeglimin may be a prime candidate for first-line treatment as monotherapy and as an add-on to other glucose-lowering therapies for the treatment of patients with type 2 diabetes."