Poxel has completed patient enrolment for the TIMES 1 trial in Japan to investigate the use of Imeglimin for the treatment of type 2 diabetes.
The Phase lll, multicentre, double-blind, placebo-controlled, randomised, 24-week, monotherapy trial enrolled more than 200 Japanese type 2 diabetes patients.
Part of the Trials of IMeglimin for Efficacy and Safety (TIMES) programme, the TIMES 1 trial is designed to evaluate the efficacy, safety and tolerability of Imeglimin in the enrolled patients.
TIMES 1’s primary endpoint is HbA1c, while its secondary endpoints are other standard glycemic and non-glycemic parameters.
The TIMES programme, which currently includes three Phase lll trials, is a joint effort between Poxel and Sumitomo Dainippon Pharma for the development and commercialisation of Imeglimin in Japan, China, South Korea, Taiwan and nine other South East Asian countries.
It expects to enrol a total of around 1,100 patients.
Poxel CEO Thomas Kuhn said: “We continue to make progress advancing all three pivotal Phase lll TIMES trials for Imeglimin in Japan and completing patient enrolment of the TIMES 1 trial is another important clinical milestone that takes us one step closer to the Phase lll data readout in 2019.
“Enrolment of the TIMES 2 and TIMES 3 trials is anticipated to be completed during the second half of 2018.
“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 is an orally available drug candidate, which features a new mechanism that can reduce glucose level by simultaneously targeting liver, muscles and the pancreas, the three key organs that play an important role in the treatment of type 2 diabetes.