Poxel SA announced that in a Phase 2 study imeglimin, a novel compound in development for Type 2 diabetes, showed incremental efficacy as an add-on therapy to sitagliptin, in patients inadequately controlled by sitagliptin monotherapy. The study achieved its primary endpoint of superiority in HbA1c (blood sugar levels) reduction versus placebo (p<0.001), and the decrease in FPG (fasting plasma glucose) was also statistically significant (p<0.006). Reduction in HbA1c and FPG are two important measures of diabetes control.
Data from the Phase 2 trial assessed the clinical benefit of adding imeglimin to sitagliptin in 150 patients. The trial demonstrated that in 12 weeks, patients in the imeglimin-sitagliptin treatment group experienced 0.73% reduction in HbA1c versus placebo. More patients responded to the imeglimin-sitagliptin treatment than to the sitagliptin-placebo treatment (p<0.001). The overall safety and tolerability profile in the imeglimin-sitagliptin group was excellent.
Professor Valdis Pirags, Principal Investigator, commented: "I am pleased to see this study meeting its end-points. Imeglimin is effective as add-on therapy to sitagliptin with a great safety/tolerability profile. Combinability associated to safety is essential for new products to tackle type 2 diabetes."
"The results from this add-on study are impressive. They do confirm the attractiveness of Imeglimin for both regulators and future prescribers: the molecule is unique and demonstrates its great efficacy potential in monotherapy as in combination with the two most important molecules on the treatment armamentarium today, metformin and sitagliptin", said Professor Harold Lebovitz, a prominent member of Poxel's scientific advisory board.
Thomas Kuhn, CEO of Poxel added: "In just two years since our first round of financing, the Company has now completed two successful Phase 2 clinical trials with Imeglimin. This second positive clinical trial demonstrates Imeglimin's potential to complement the efficacy of major drugs, which brings further value to our compound and added confidence in its further development. Within the type 2 diabetes landscape, Imeglimin is ahead in a race where new entrants have yet to prove their efficacy, their combinability and their safety."
Date: November 5, 2012
Source: Poxel SA