POXEL and Sumitomo Dainippon Pharma announced 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 (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 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. “Imeglimin’s 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<0.0001) for its primary endpoint, defined as a change of glycated hemoglobin A1c (HbA1c) versus placebo at week 24, with an HbA1c placebo-corrected mean change from baseline of -0.87%.
For the trial’s main secondary endpoint of a decrease from baseline in fasting plasma glucose (FPG), Imeglimin achieved statistical significance (p<0.0001) versus placebo at week 24, with a FPG placebo-corrected mean change from baseline of -19 mg/dL. Analyses of data for the additional secondary endpoints are ongoing. In this trial, the overall safety and tolerability of Imeglimin was similar to placebo and the adverse event profile was consistent with what was observed in the Phase 2b trial in Japan and the U.S. and European Phase 1 and 2 programs.
“This is a significant milestone for Poxel and for the development of our most advanced drug candidate. The TIMES 1 results confirm the robust efficacy combined with favorable safety observed in the Phase 2b trial in Japan and the potential benefits that Imeglimin can bring to type 2 diabetes patients globally,” said Thomas Kuhn, CEO of Poxel. “The TIMES 1 data is the first major step towards filing the Japanese New Drug Application in 2020. Japan represents the second largest single market for type 2 diabetes and, Asia, in broader terms, is considered the most important geographic location with regards to treating the diabetes pandemic in the future.”
The TIMES program is a joint development effort between Poxel and Sumitomo Dainippon Pharma. The companies entered into a strategic partnership in October 2017 for the development and commercialization of Imeglimin in Japan, China, South Korea, Taiwan and nine other Southeast and East Asian countries.
“Our commitment to diabetes patients is to continue to innovate and provide new therapeutic options to help them manage their disease. We are very pleased with the TIMES 1 data results and to be working closely with Poxel on the TIMES clinical trials,” said Nobuhiko Tamura, Senior Executive Officer; Drug Development Division of Sumitomo Dainippon Pharma. “Diabetes is a significant area for our company in Japan, and we believe that Imeglimin will be a very important addition to our existing diabetes franchise.”
Poxel anticipates presenting data results from the Phase 3 (TIMES 1) trial at an upcoming scientific meeting.
Soure: Company Press Release