Imeglimin Phase IIb study in Japan for type 2 diabetes meets endpoint

French diabetes focused biotech firm Poxel (Euronext: POXEL) today announced additional results from the imeglimin Phase IIb study conducted in Japan. The firm’s share were up 3.9% at 7.66 euros in late morning trading, having earlier hit a day’s high of 7.97 euros.

The Phase IIb randomized, double-blind, placebo-controlled study tested three doses of imeglimin (500mg, 1,000mg and 1,500mg) administered twice-daily for 24 weeks in 299 Japanese patients for the treatment of type 2 diabetes. In this study, a statistically-significant (p<0.0001) decrease in the primary endpoint of HbA1c was observed along with consistent, statistically-significant (p<0.0001) decreases in the key secondary endpoints of fasting plasma glucose, glycated albumin and percentage of patients reaching a target HbA1c of less than 7%.

A statistically-significant dose dependent (500mg p=0.008,1,000mg p=0.0008, and 1,500g p<0.0001) improvement of the homeostasis model assessment of beta-cell function (HOMA-B), a marker of beta cell function in fasting condition, was also observed and is consistent with previously published data. In addition, there was a significant decrease in two of the most relevant liver enzymes, alanine aminotransferase (ALT) and gamma-glutamyl transferase (GGT), which are considered biomarkers in liver disease. The ALT and GGT results reflect an improvement of liver function and are consistent with previously published data in animal models. These data support imeglimin’s unique dual mechanism of action of improving both insulin secretion and sensitivity, which are the two key defects that cause type 2 diabetes.