Poxel has enrolled the first patient in a multi-centre, double-blind, placebo-controlled Phase IIb clinical study of Imeglimin, a drug in development for the treatment of type 2 diabetes.
Featuring a mitochondrian-based mechanism of action, Imeglimin inhibits hepatic gluconeogenesis, increases muscle glucose uptake and restores normal insulin secretion.
The trial, which will recruit 350 patients, will select men and women aged between 18 and 75 with type 2 diabetes, and who have not been treated previously with oral anti-diabetic monotherapy, including metformin, sulfonylurea, dipeptidyl peptidase 4 (DPP- 4) inhibitors, glinide or acarbose.
With the trial, the company intends to confirm Imeglimin’s efficacy in monotherapy, and complete the data package for partnering discussions.
The trial will also recruit some patients presenting with mild to moderate renal impairment, according to the company.
The study will randomise patients into five parallel groups, including four Imeglimin groups and one placebo group, and will assess the dose-response of Imeglimin at four dose levels compared to placebo in type 2 diabetes patients after 24 weeks of treatment.
The primary endpoint of the study includes change in glycosylated hemoglobin (HbA1c), while the secondary endpoint includes the optimal dose and activity of Imeglimin compared to placebo on other glycemic and non-glycemic parameters.
In addition, the trial will assess the tolerability and safety of Imeglimin compared to placebo.
During the company’s Phase II study, Imeglimin achieved its primary endpoint of reducing HbA1c from baseline to week 12 versus placebo plus sitagliptin, and also met the secondary endpoint of reducing fasting plasma glucose (FPG) from baseline to week 12 versus placebo (p<0.006).
Poxel CEO Thomas Kuhn said; "This is a very important milestone for Imeglimin and Poxel; we have already proved Imeglimin as an excellent add-on therapy to the standard treatments for type 2 diabetes."