French biopharmaceutical firm Poxel has concluded patient enrolment in the Phase III TIMES 2 clinical trial of its drug candidate Imeglimin for the treatment of type 2 diabetes in Japan.
Imeglimin is a first-in-class, investigational, orally available therapeutic agent targeting mitochondrial bioenergetics. It acts on the liver, muscles and the pancreas, which are known to be associated with the treatment of type 2 diabetes.
The open-label, parallel-group TIMES 2 trial is designed to evaluate the long-term safety and efficacy of Imeglimin as a monotherapy or combination therapy over 52 weeks in 700 participants with current hypoglycemic agents.
TIMES 2 is part of the Phase III registration programme (TIMES), which is being conducted by Poxel in partnership with Sumitomo Dainippon Pharma to study 1,000mg twice-daily Imeglimin in a total of more than 1,100 Japanese patients.
The partners formed an alliance in October last year for the development and commercialisation of the drug candidate in Japan, China, South Korea, Taiwan and nine other South East and East Asian markets.
Aside from TIMES 2, the Phase III programme comprises two other trials, TIMES 1 and TIMES 3.
Poxel CEO Thomas Kuhn said: “In less than one year after signing the strategic partnership with Sumitomo Dainippon Pharma, we have made substantial progress advancing all three pivotal Phase III TIMES trials for Imeglimin in Japan.
“We remain on track for the TIMES 1 data results in the second quarter of 2019 and the TIMES 2 and TIMES 3 data results are anticipated in the second half of 2019.”
In pre-clinical studies, Imeglimin is said to have shown the potential to address mitochondrial dysfunction, which is believed to be the primary driver of type 2 diabetes pathophysiology.
The drug has already been assessed in Phase I and Phase II trials in more than 1,200 patients across the US, Europe and Japan.