Updated on 1 July 2016
Singapore: French biopharmaceutical company Poxel SA has announced that the company has completed patient enrollment for the phase IIb clinical trial of Imeglimin in type 2 diabetes patients in Japan.
Imeglimin is the first in a new class of oral anti-diabetic agents targeting mitochondrial bioenergetics and has completed phase II development in over 850 patients in the United States and Europe.
The dose-ranging, randomized, double-blind, placebo-controlled phase IIb study in Japan is supervised by Professor Kohjiro Ueki, Department of Diabetes and Metabolic Disease at the University of Tokyo and been designed to include approximately 300 naïve and pre-treated patients. Following recruitment and a six-to-ten week washout period, patients are randomized into 24 weeks of treatment. The primary endpoint of the trial is efficacy measured by change in glycated haemoglobin HbA1c concentrations.
"I am pleased to report that we have reached another important clinical milestone as we continue to advance Imeglimin into late-stage development in Japan," said Thomas Kuhn, CEO of Poxel. "As the second largest single market for type 2 diabetes with approximately $4 billion in annual sales and growing, Japan is a key focus for Poxel and we are excited with our progress. We are on track to report the phase IIb results during the first half of next year."
Poxel has worked in close collaboration with the Japanese Pharmaceutical and Medical Device Agency (PMDA) to plan for the phase III development program in Japan, which Poxel expects to be in the position to initiate during the second half of 2017.