Clinical developments

N-Gene has completed three POC/POE human clinical trials in insulin resistance related therapeutic indications. Main figures of such human studies are summarized below:

BGP-15-CLIN-IR01 (EUDRA CT code: 2005-000872-41), a 28-day study

BGP-15 significantly improved insulin resistance in prediabetic patients (hyperinsulinemic euglycemic clamp). (No SAE was reported.)

BGP-15-CLIN-IR03, a 17-day study

BGP-15 significantly prevented olanzapine induced deterioration of insulin sensitivity. (No SAE was reported.)

BGP-15-CLIN-IR04 (EUDRA CT code: 2009-013328-21, BfArM file #: 61-3910-4036614), a 13-week multicenter study

As a result of heavily underpowered data due to early termination and unexpected and sizeable decrease in HbA1c in the placebo group (-0.31%), LOCF analyses of data showed no significant reduction in HbA1c compared to placebo in the primary target 400 mg TDD group (200 mg BID + 400 mg QD groups). In contrast, the 200 mg TDD group, particularly the 200 mg QD sub-group, was more effective. (No SAE was reported.)