The randomized, double-blind, placebo-controlled study of Imeglimin administered twice-daily for 24 weeks, demonstrated dose-dependent efficacy on two key measures of diabetes control in 299 Japanese patients.
The trial achieved statistical significance (p<0.0001) for its primary endpoint of glycated hemoglobin A1c reduction versus placebo in all treatment groups at 24 weeks.
In the study, hemoglobin A1c reduction was 0.52%, 0.94% and 1.00% for the 500 mg, 1000 mg and 1500 mg dose twice-daily, respectively. The level of reduction of hemoglobin A1c for Imeglimin was even more pronounced in the Japanese Phase 2b data than what has previously been shown in the U.S. and EU Phase 2b data.
For the study’s key secondary endpoint of a decrease in Fasting Plasma Glucose (FPG), the top two Imeglimin doses of 1000 mg and 1500 mg achieved statistical significance (p<0.0001) versus placebo at 24 weeks.
Analyses of data for the additional secondary endpoints are ongoing. In this study, Imeglimin was shown to be safe and well tolerated and the adverse event profile was consistent to what was observed in the U.S. and EU Phase 1 and 2 programs.
The Company anticipates meeting with the Pharmaceuticals and Medical Devices Agency in Japan during the third quarter, and pending feedback from the meeting, the Company plans to be in the position to advance Imeglimin into a Phase 3 program in Japan during the fourth quarter of 2017.
Pascale Fouqueray, MD, PhD, Executive Vice President, Early Development & Translational Medicine of Poxel, said: "The strong efficacy of Imeglimin observed in this study suggests that its innovative mechanism of action may play an important role in the treatment of type 2 diabetes and could be particularly well-suited for Japanese patients.
“Imeglimin has been successfully studied in over 1,200 subjects and has shown a differentiated product profile combined with favorable safety, and we believe that it has the potential to address the large and growing needs of the type 2 diabetes market.”
Christophe Arbet-Engels, MD, PhD, MBA, Chief Medical Officer and Executive Vice President, Late Development & Medical Affairs of Poxel, said: “We are very pleased with these results and are actively preparing for the Imeglimin Phase 3 program in Japan. The Phase 3 program is anticipated to include 3 pivotal trials as well as non-pivotal studies in specific patient populations to further differentiate Imeglimin from other approved therapies in Japan.
“Diabetes is a growing health concern in Asia and with these data results we are encouraged that Imeglimin could become an innovative new treatment option for Japanese patients to manage their type 2 diabetes.”
Thomas Kuhn, CEO of Poxel said: "This is a significant milestone for Poxel. Japan is a key focus and is an integral part of our business strategy, especially with the unique treatment paradigm for innovative therapies. 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.
“Japan represents the second largest single market for type 2 diabetes and is expected to grow to approximately $6 billion in annual sales in 2020*. Asia, in broader terms, is considered the most important geographic location with regards to treating the diabetes pandemic in the future."
Poxel anticipates presenting the full data results of the Phase 2b study in Japanese patients at scientific meetings during the second half of 2017.