Strong top-line results for Poxel's antidiabetic agent imeglimin

France-based drug developer Poxel says that imeglimin, a novel compound in development to treat type 2 diabetes, demonstrated dose-dependent efficacy on two key measures of diabetes control in a Phase IIb trial conducted in both treatment-naïve patients and patients previously treated with a diabetes monotherapy.

Poxel, founded in 2009 as a spun out from Merck Serono and now operates independently, says the trial achieved its primary endpoint of HbA1c reduction versus placebo (p<0.001), and significant decrease in FPG (Fasting Plasma Glucose) (p<0.006) at a dose of 1500mg, which will be the dose the company will advance into a Phase III development program.

This Phase IIb trial assessed the efficacy and safety profile of four doses of imeglimin in 382 patients after 24-week treatment. In addition to the HbA1C and FPG reductions obtained with the 1,500mg dose, the number of responders (defined as patients achieving an HbA1C below 7% at the end of the treatment) was statistically significant (p=0.005) and no patient required rescue therapy (p=0.01) during the trial’s duration. The overall safety and tolerability profile was positive in all imeglimin groups, with a similar overall incidence of adverse events between treatment groups and placebo group. The trial reported no serious adverse events related to the treatment with imeglimin. Poxel anticipates reporting final analysis of the trial data at an international scientific meeting in 2015.

Further support for therapeutic profile