LYON - POXEL SA (Euronext - POXEL - FR0012432516), a biopharmaceutical company focused on the development of innovative treatments for metabolic disorders, including type 2 diabetes and non-alcoholic steatohepatitis (NASH) and Sumitomo Dainippon Pharma Co., Ltd (Head Office: Osaka, Japan; Representative Director, President and CEO: Hiroshi Nomura; Securities Code: 4506, First Section of TSE), announced today positive top-line Phase 3 data results for the Imeglimin TIMES 3 16-week, double-blind, placebo-controlled, randomized part of the trial for the treatment of type 2 diabetes in Japan.
Referred to as TIMES (Trials of IMeglimin for Efficacy and Safety), the Imeglimin Phase 3 program in Japan includes three pivotal trials to evaluate Imeglimin's efficacy and safety in over 1,100 patients.
'I am very excited to contribute to the development of a new and innovative potential treatment option for Japanese patients with type 2 diabetes,' said Professor Hirotaka Watada, MD, PhD, Professor, Department of Medicine, Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan. 'Imeglimin's safety profile combined with its unique mechanism of action that targets very important deficiencies occurring in diabetes, could be helpful for Japanese patients treated with insulin to further manage their advanced disease.'
The TIMES 3 16-week, double-blind, placebo-controlled, randomized part of the trial evaluated efficacy and safety of Imeglimin in 215 patients. In this trial, Imeglimin 1,000 mg was orally administered twice-daily in combination with insulin in Japanese patients with type 2 diabetes and inadequate glycemic control on insulin therapy versus patients administered placebo and insulin. The TIMES 3 trial was observed to demonstrate efficacy and achieved statistical significance (p
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