The Imeglimin Phase 3 registration program in Japan includes three trials to evaluate the efficacy and safety of Imeglimin in approximately 1,100 patients. The TIMES 1 trial is a multicenter, double-blind, placebo-controlled, randomized, monotherapy study in over 200 Japanese patients with type 2 diabetes.
Imeglimin is a clinical candidate in a new chemical class of oral agents called glimins by the World Health Organization. Imeglimin has a mechanism of action (MOA) that targets mitochondrial bioenergetics and acts on all three key organs, liver, muscle, and pancreas, which play an important role in the treatment of type 2 diabetes.
This MOA has the potential to prevent endothelial and diastolic dysfunction, which can provide protective effects on micro- and macro-vascular defects induced by diabetes. It also has the potential for protective effect on beta-cell survival and function.
TIMES, the Phase 3 program for Imeglimin for the treatment of type 2 diabetes in Japan, consists of three trials involving approximately 1,100 patients. The TIMES program includes three trials that will be performed using the dose of 1,000 mg twice daily.
Poxel is focused on the development of innovative treatments for metabolic diseases, including type 2 diabetes and non-alcoholic steatohepatitis.
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