French biopharmaceutical firm Poxel and its Japanese partner Sumitomo Dainippon Pharma have reported positive results from the Phase III TIMES 3 clinical trial of Imeglimin to treat type 2 diabetes patients.
TIMES (Trials of Imeglimin for Efficacy and Safety) is a Phase III programme in Japan that consists of three pivotal trials to analyse efficacy and safety of Imeglimin in more than 1,100 patients.
The 16-week, double-blind, placebo-controlled, randomised part of the TIMES 3 trial was carried out in 215 patients.
Under this trial, 1,000mg Imeglimin was administered twice daily along with insulin in patients suffering from type 2 diabetes and inadequate glycemic control on insulin therapy versus patients administered placebo and insulin.
The TIMES 3 trial demonstrated efficacy as well as achieved statistical significance for its primary endpoint.
The primary endpoint is defined as a change of glycated hemoglobin A1c (HbA1c) from baseline as against placebo at week 16. The mean HbA1c placebo-corrected change from baseline is defined as -0.60%.
The overall safety and tolerability profile of the drug was observed to be similar to that of placebo.
A similar number of patients experienced hypoglycemia with Imeglimin as against the placebo group with a fixed insulin daily dose as mentioned in the protocol.
No severe hypoglycemia events were reported and the majority of the hypoglycemia events were mild in nature.
Furthermore, the adverse event profile was similar to placebo. It was also consistent with that of the Phase 3 TIMES 1 monotherapy trial and other Imeglimin clinical trials.
Further analyses of the trial, including secondary endpoints, are ongoing.
Poxel CMO and executive vice president for late development and medical affairs Arbet-Engels said: “The TIMES 3 16-week results are the second positive readout from the three pivotal trials in the TIMES programme and follow the positive TIMES 1 monotherapy results announced in April 2019.
“We are working very closely with our partner Sumitomo Dainippon Pharma in preparing for the Japanese New Drug Application and these results bring us one step closer to achieving that goal.”
Sumitomo Dainippon Pharma senior executive officer for drug development division Nobuhiko Tamura said: “Diabetes is a significant area for our company in Japan and we believe that Imeglimin will be a very important addition to our existing diabetes franchise.”
The TIMES trial is a joint initiative between Poxel and Sumitomo Dainippon Pharma.
In October 2017, the two firms entered into a strategic partnership for the development and commercialisation of Imeglimin in Japan, China, South Korea, Taiwan, and nine other East Asian countries.
Phase III results from the TIMES 2 and 36-week open-label extension part of TIMES 3 are expected by the end of 2019