Poxel has commenced its TIMES 2 and TIMES 3 trials in Japan, examining the use of Imeglimin for the treatment of type 2 diabetes.
Both studies are part of the Trials of IMeglimin for Efficacy and Safety (TIMES) programme, which includes three studies involving around 1,100 patients.
The programme has been conducted under a joint development effort between Poxel and Sumitomo Dainippon Pharma.
TIMES 2 is a Phase III, 52-week study designed to examine the long-term safety and efficacy of Imeglimin in Japanese patients with type 2 diabetes.
In the trial, Imeglimin will be administered orally either as a monotherapy or combination therapy. In the latter instance it will be given with existing hypoglycemic agents, including a DPP4 inhibitor, SGLT2 inhibitor, biguanide, sulphonylurea and GLP1 receptor agonist.
TIMES 3 is a Phase III, 16-week, placebo-controlled trial.
It features a 36-week open-label extension period to analyse the efficacy and safety of Imeglimin in combination with insulin in Japanese patients with type 2 diabetes and inadequate glycemic control on insulin therapy.
Poxel CEO Thomas Kuhn said: “Over the last few months, we have made significant progress advancing the TIMES programme for Imeglimin in Japan with the initiation of all three pivotal Phase III trials.
“We are on track for the Phase III data readout in 2019.
“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.”
Imeglimin simultaneously targets the three key organs that help treat type 2 diabetes; the liver, muscles and pancreas. Such a mechanism has been observed in clinical studies to have glucose-lowering benefits.
Japan is the second largest single market for type 2 diabetes outside of the U.S. and is expected to grow to approximately $6 billion in 2021.