24 September 2019 - - French biopharmaceutical company Poxel S.A. (Euronext POXEL FR0012432516) has presented detailed Phase 3 results from the TIMES 1 programme, which evaluated the efficacy, safety and tolerability of Imeglimin in Japanese patients with type 2 diabetes as well as data supporting the safety and efficacy of Imeglimin in various patient populations, the company said.

The data were featured in a symposium session at the 55th annual meeting of the European Association for the Study of Diabetes, held at the Fira Barcelona Gran Via conference center in Barcelona, Spain from September 16-20, 2019.

The session was chaired by leading academic diabetes expert, Ralph DeFronzo, M.D., Professor of Medicine and Chief of the Diabetes Division at UT Health San Antonio and Deputy director of the Texas Diabetes Institute, part of University Health System, San Antonio, Texas.

The symposium included a specific focus on the patient population in Japan and the detailed Phase 3 TIMES 1 trial results.

Asia is considered one of the most important geographic locations in treating the diabetes pandemic in the future, with Japan being the second largest single market after the US Imeglimin Phase 3 TIMES 2 and TIMES 3 36-week open label results are expected around the end of 2019.

A Japanese New Drug Application for Imeglimin is targeted for 2020.

Imeglimin's unique mechanism of action, coupled with its efficacy and safety profile, illustrates Imeglimin's potential to be a candidate worldwide for the treatment of type 2 diabetes in almost all stages of the current anti-diabetic treatment paradigm, including monotherapy, or as an add-on to other glucose lowering therapies and in various populations of patients with type 2 diabetes.

Data presented at the symposium included results from the Phase 3 TIMES 1 randomized, double-blind, placebo-controlled monotherapy trial.

In this trial, Imeglimin was orally administered 1,000 mg twice daily versus placebo for 24 weeks in 213 Japanese patients.

The TIMES 1 trial demonstrated robust efficacy and achieved statistical significance (p