Poxel SA announces positive top-line results for new oral anti-sugar drug imeglimin key phase III TIMES 3 study

Recently, Poxel SACompany(http://announced the positive top-line results of the 36-week open label extension of the new oral sugar-reducing drug imeglimin key PHASE III TIMES 3 studyAbout TIMES 3
TIMES 3 is a study in the Imeglimin PHASE III Clinical Development Project TIMES, which is evaluating the efficacy and safety of imeglimin in the treatment of patients with type 2 diabetes in Japan to support the safety and efficacy of imeglimin in different patient groupsThe project included three key Phase III studies involving more than 1,100 patients, in which imeglimin was given a dose of 1000 mg and taken orally twice dailyThe TIMES 2 results are expected by the end of 2019, after which Roxel will submit itsnew drug(http://(NDA) application in Japan in 2020 with partner SumitomoPharmaceutical(http://TIMES 3 is a 16-week, double-blind, placebo-controlled, randomized study with a 36-week open label extension periodThe study enrolled 215 patients with type 2 diabetes who received insulin-treated blood sugar level control in Japan and assessed the efficacy and safety of imeglimin and insulin combination therapyThe main endpoint of the study was the relative baseline change in the treatment of glycated hemoglobin A1c (HbA1c) at week 16 　　The 16-week portion of the study reached its main endpoint and a good safety and tolerance profile was observed, with the top line results released on June 25, 2019 　　The results showed that imeglimin combined insulin therapy showed significant lysing effects: in the 16th week of treatment, the relative baseline of HbA1c in the imeglimin-insulin therapy group was significantly reduced (the average change in the relative baseline of HbA1c after placebo correction was -0.60%), with statistically significant differences (p 0.0001) During 16 weeks of treatment, imeglimin was similar to placebo in terms of overall safety and tolerance The incidence of hypoglycemia was similar in 2 groups, with most hypoglycemia events being mild and no severe hypoglycemia events 　　the adverse event profile of imeglimin was consistent with the placebo and was consistent with the phase III TIMES 1 single-drug study and other imeglimin clinical studies 'The about imeglimin imeglimin belongs to a new class of oral chemicals called Glimins, which is the first candidate product (http:// to enter clinical development in this category of drug (http:// , with a unique mechanism of action 　　imeglimin has been shown to reduce blood sugar by increasing insulin secretion, increasing insulin sensitivity, and inhibiting the effects of sugar isogenesis (gluconeogenesis) 　　imeglimin also has potential protective effects on the survival and function of beta cells