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Poxel Completes Patient Enrollment for TIMES 1 Trial in the Phase 3 Registration Program for Imeglimin

  • Phase 3 TIMES 1 data readout is on track for the second quarter of 2019
  • Japanese New Drug Application submission for Imeglimin targeted in 2020
  • Diabetes is a fast-growing market in Asia and Japan is the second largest single market for type 2 diabetes outside of the U.S.; it is expected to grow to approximately $6 billion in 2020

 POXEL SA (Euronext – POXEL - FR0012432516), a biopharmaceutical company focused on the development of innovative treatments for metabolic diseases, including type 2 diabetes and non-alcoholic steatohepatitis (NASH), announced today that patient enrollment for the TIMES 1 trial in the Phase 3 program for Imeglimin, an investigational therapeutic agent for type 2 diabetes, in Japan has been completed. Referred to as TIMES (Trials of IMeglimin for Efficacy and Safety), the Imeglimin Phase 3 registration program in Japan includes three pivotal 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.

 

 

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