French biopharmaceutical firm Poxel and its Japanese partner Sumitomo Dainippon Pharma have reported positive results from the Phase III TIMES 1 clinical trial of Imeglimin in type 2 diabetes patients.
According to the top-line data, the trial met its primary endpoint with statistical significance in change of glycated haemoglobin A1c (HbA1c) at week 24, compared to placebo.
Imeglimin is an oral anti-diabetes candidate that simultaneously targets the pancreas, liver, and muscles.
In the pancreas, the therapeutic increases insulin secretion, while reducing excess glucose production in the liver and increasing insulin sensitivity in the muscles.
The 24-week, double-blind, placebo-controlled, randomised TIMES 1 trial was conducted in 213 Japanese patients to evaluate the safety, efficacy, and tolerability of 1,000mg Imeglimin as a monotherapy.
In addition to the primary endpoint, the trial also achieved statistical significance for its secondary endpoint of a decrease in fasting plasma glucose (FPG) at week 24 from baseline.
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Analyses of findings for the other secondary endpoints are ongoing.
The overall safety and tolerability profile of the drug was observed to be similar to that of placebo.
Also, the adverse event profile was consistent with data from the Phase IIb trial in Japan and the US, and the Phase I and II programmes conducted in Europe.
Poxel CEO Thomas Kuhn said: “The TIMES 1 results confirm the robust efficacy combined with favourable safety observed in the Phase IIb trial in Japan and the potential benefits that Imeglimin can bring to type 2 diabetes patients globally.
“The TIMES 1 data is the first major step towards filing the Japanese new drug application in 2020.”
The company partnered with Sumitomo Dainippon Pharma in 2017 to develop and commercialise the drug in Japan, China, South Korea, Taiwan and nine additional Southeast and East Asian markets.
TIMES 1 is part of the partners’ Japanese Imeglimin Phase III programme, which comprises three pivotal trials in more than 1,100 patients.
The companies noted that Japanese diabetes market is predicted to reach around $6bn by 2020.