Poxel announces Positive Top Line Results for Its Antidiabetic Agent Imeglimin in a Phase 2b Dose-Ranging Trial
Wednesday, December 17, 2014
Poxel SA today announced 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 2b trial conducted in both treatment-naïve patients and patients previously treated with a diabetes monotherapy. 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 Poxel will advance into a phase 3 development program.
This phase 2b trial assessed the efficacy and safety profile of 4 doses of Imeglimin in 382 patients after 24-week treatment. In addition to the HbA1C and FPG reductions obtained with the 1500mg 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.
Professor Valdis Pirags, Principal Investigator and member of the Faculty of Medicine University of Latvia, commented, “These data further support the therapeutic profile of Imeglimin we have reported to date and provide hope at a time when physicians are seeking new therapeutic options for helping patients to control their disease.”
“Imeglimin shows great promise with this positive phase 2b trial for both its success in meeting the trial’s endpoints and its safety/tolerability profile. These data confirm the potential of this agent that was also demonstrated as an add-on treatment to the two main marketed products, metformin and sitagliptin,” said Professor Harold Lebovitz, Professor of Medicine in the Division of Endocrinology and Metabolism/Diabetes at State University of NY, Brooklyn, and a prominent member of Poxel’s Scientific Advisory Board.
Thomas Kuhn, CEO of Poxel added, “With this initial analysis, Poxel has reached a key milestone, confirming the potential of its most advanced asset, Imeglimin, and allowing the company to advance to late-stage clinical trials. These results are also instrumental in achieving our goals as a company.”
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