Phase III TIMES 2 trial of imeglimin shows positive results in type 2 diabetes.- Poxel/Sumitomo Dainippon Pharma

POXEL and Sumitomo Dainippon Pharma announced positive topline results from TIMES 2, a Phase III trial evaluating imeglimin in combination with approved hypoglycemic therapies, and as a monotherapy, for the treatment of type 2 diabetes in Japan. These results mark the successful conclusion of the Phase III program in Japan, referred to as TIMES (Trials of IMeglimin for Efficacy and Safety), which included three pivotal trials to evaluate Imeglimin’s efficacy and safety in over 1,100 patients. The TIMES 2 trial, which was open-label and not placebo-controlled, was observed to show a glycated hemoglobin A1c (HbA1c) decrease from baseline at the end of the 52-week treatment (LS mean) period of: -0.92% versus baseline with Imeglimin as an add on to a DDP-4 inhibitor, -0.88% versus baseline with Imeglimin as an add on to a thiazolidine, -0.85% versus baseline with Imeglimin as an add on to an alpha-glucosidase inhibitor, -0.70% versus baseline with Imeglimin as an add on to a glinide, -0.67% versus baseline with Imeglimin as an add on to a biguanide, -0.57% versus baseline with Imeglimin as an add on to a SGLT2 inhibitor, -0.56% versus baseline with Imeglimin as an add on to a sulphonylurea, -0.12% versus baseline with Imeglimin as an add on to a GLP1 receptor agonist and -0.46% versus baseline with Imeglimin as monotherapy. The TIMES 2 trial met another important efficacy endpoint and was observed to show a decrease in fasting plasma glucose (FPG) that was consistent with the reduction in HbA1c, except in the GLP1 group, which showed a stronger reduction in FPG when compared to the observed decrease in HbA1c. In addition, the HbA1c and FPG decrease for Imeglimin as monotherapy were similar to previous studies in this population when measured from baseline (not placebo controlled), such as the Phase IIb trial in Japan. In this trial, Imeglimin demonstrated a favorable safety and tolerability profile that was observed across all arms of the study. In addition, the adverse event profile was consistent with what was observed in the TIMES 1 monotherapy trial, the TIMES 3 trial in combination with insulin and prior clinical studies of Imeglimin. Comment: The TIMES 2 trial further strengthens Imeglimin’s differentiated profile showcasing that its dual mechanism of action of increasing insulin secretion in response to glucose and improving insulin sensitivity was observed to show added efficacy benefits, especially with agents that have complementary mechanisms of action. Poxel anticipates submitting the full data results from the Phase III TIMES 2 trial for presentation at a scientific meeting 2020.