Poxel SA, a biopharmaceutical company focused on the development of innovative treatments for metabolic disorders, including type 2 diabetes, and Sumitomo Dainippon Pharma, announced the initiation of the phase 3 programme 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 programme in Japan will include three pivotal trials to evaluate Imeglimin’s efficacy and safety in approximately 1,100 patients. In December 2017, the first patient was included in the TIMES 1 trial, a multicenter, double-blind, placebo-controlled, randomized, monotherapy study in over 200 Japanese patients with type 2 diabetes.

The TIMES programme 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.

“Initiation of the TIMES programme is a major milestone for Poxel and for the development of Imeglimin with our partner Sumitomo Dainippon Pharma. Based on the success of our phase 2 program, we have a clear roadmap for the phase 3 TIMES program,” said Thomas Kuhn, CEO of Poxel. “Our near-term focus in Japan is the successful execution of TIMES, and, to this end, we will work closely with our colleagues at Sumitomo Dainippon Pharma to support the Japanese New Drug Application submission.”

“Our commitment to diabetes patients is to continue to innovate and provide the best medicines to help them manage their disease. We are pleased to be working closely with Poxel and initiating the TIMES registration studies,” said Nobuyuki Hara, director, executive officer; Drug Development Division of Sumitomo Dainippon Pharma. “Diabetes is a significant area for us in Japan and we believe that Imeglimin will be a very important addition to our existing diabetes franchise.”

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 development in over 1,200 subjects in the US, EU and Japan.