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Poxel Announces Initiation of TIMES 2 and TIMES 3 Trials for the Phase 3 Program for Imeglimin, an Investigational Therapeutic Agent for Type 2 Diabetes, in JapanPOXEL 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 the initiation of the TIMES 2 and TIMES 3 trials for the Phase 3 program for Imeglimin, an investigational therapeutic agent for 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 approximately 1,100 patients. "Over the last few months, we have made significant progress advancing the TIMES program for Imeglimin in Japan with the initiation of all three pivotal Phase 3 trials. We are on track for the Phase 3 data readout in 2019," said Thomas Kuhn, CEO of Poxel. "Our near-term focus in Japan is the successful execution of TIMES, and to this end, we are working closely with our colleagues at Sumitomo Dainippon Pharma to support the Japanese New Drug Application submission anticipated in 2020." The TIMES program is a joint development effort between Poxel and Sumitomo Dainippon Pharma. The companies announced on October 30, 2017, a strategic partnership for the development and commercialization of Imeglimin in Japan, China, South Korea, Taiwan and nine other Southeast Asian countries.2 Through this partnership, the TIMES 1 trial in Japan was initiated in December 2017. Imeglimin is an orally-available drug candidate with a novel mechanism of action that has been observed in clinical studies to demonstrate glucose lowering benefits by simultaneously targeting all three key organs which play an important role in the treatment of type 2 diabetes: the liver, muscles and the pancreas. Imeglimin has demonstrated in preclinical studies the potential to address mitochondrial dysfunction, which is believed to be at the core of type 2 diabetes pathophysiology. Imeglimin has completed Phase 1 and Phase 2 develpment in over 1,200 subjects in the U.S., EU and Japan.
About the TIMES Program TIMES 1: A Phase 3, 24-week, double-blind placebo-controlled, randomized, monotherapy study to assess the efficacy, safety and tolerability of Imeglimin in Japanese patients with type 2 diabetes, using the change in HbA1c as the primary endpoint. Secondary endpoints of the trial will include other standard glycemic and non-glycemic parameters. TIMES 2: A Phase 3, 52-week, open-label, parallel-group study to assess the long-term safety and efficacy of Imeglimin in Japanese patients with type 2 diabetes. In this study, Imeglimin will be administrated orally as a monotherapy or combination therapy with existing hypoglycemic agents, including a DPP4 inhibitor, SGLT2 inhibitor, biguanide, sulphonylurea and GLP1 receptor agonist. TIMES 3: A Phase 3, 16-week, double-blind, placebo-controlled, randomized study with a 36-week open-label extension period to evaluate the efficacy and safety of Imeglimin in combination with insulin in Japanese patients with type 2 diabetes and inadequate glycemic control on insulin therapy.
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1Source (News - Alert): Oppenheimer & Co. estimates.
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