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 1 trial for the treatment of type 2 diabetes in Japan. Referred to as TIMES ( T rials of IM eglimin for E fficacy and S afety), the Imeglimin Phase 3 program in Japan includes three pivotal trials to evaluate Imeglimins 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 Kohjiro Ueki, MD, PhD, Director, Diabetes Research Center, the National Center for Global Health and Medicine, Tokyo, Japan. Imeglimins safety profile combined with its unique mechanism of action that targets very important deficiencies occurring in diabetes, namely beta-cell function, as well as insulin resistance, could be helpful for Japanese patients to manage their disease.
The TIMES 1 randomized, double-blind, placebo-controlled monotherapy trial orally administered 1,000 mg of Imeglimin twice-daily versus placebo for 24 weeks in 213 Japanese patients. The TIMES 1 trial demonstrated robust efficacy and achieved statistical significance (p
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