Poxel's imeglimin meets in first Japanese Phase III for Type II diabetes

Poxel and Sumitomo said imeglimin met the primary endpoint in the Japanese Phase III TIMES 1 trial to treat Type II diabetes. The partners reiterated their plan to submit in 2020 an NDA to Japan’s Ministry of Health, Labour and Welfare (MHLW) for imeglimin in the indication.

Poxel S.A. (Euronext:POXEL) and Sumitomo Dainippon Pharma Co. Ltd. (Tokyo:4506) said twice-daily 1,000 mg imeglimin as monotherapy significantly reduced HbA1c from baseline to week 24 vs. placebo (placebo-corrected mean change of 0.87%, p<0.0001). Imeglimin also met the secondary endpoint of reducing fasting plasma glucose (FPG) from baseline to week 24 vs. placebo (placebo-corrected mean change of 19 mg/dL, p<0.0001). The double-blind trial enrolled 213 patients...