Metabolex completes enrollment of diabetes drug trial

Metabolex will receive a milestone payment from Ortho-McNeil, which holds an exclusive license for worldwide development and commercialization of MBX-102/JNJ 39659100.

The company expects to share results from the trial early next year, when all patients have completed the 16-week trial and the data has been examined.

The randomized, double-blind, placebo- and active comparator-controlled, multicenter Phase II/III trial is evaluating MBX-102/JNJ 39659100 at daily doses of 200, 400 and 600mg versus Actos 30mg in patients with type II diabetes taking concomitant insulin.

The primary endpoint is change in hemoglobin A1c (HbA1c) levels – the gold-standard measure of a patient’s blood glucose control over time – with weight gain and edema as key secondary endpoints. Fasting blood glucose, triglycerides, cholesterol, uric acid and adiponectin levels are being evaluated. The trial is being conducted at 67 clinical sites in four countries.

MBX-102/JNJ 39659100 is being studied for its potential to lower blood glucose by treating insulin resistance, an underlying cause of type II diabetes, and a potential contributor to cardiac disease. The drug modulates genes that are linked to insulin sensitization without appearing to affect those genes associated with weight gain and edema, unlike the currently marketed insulin sensitizers from the thiazolidinedione (TZD) class. Clinical research to date suggests the difference in gene expression may offer the efficacy advantages of TZDs with an improved safety profile, the company says.

In June 2006, Metabolex struck a deal with Ortho-McNeil, giving it an exclusive license for worldwide development and commercialization of MBX-102/JNJ 39659100. Metabolex is conducting the Phase II/III trial of the drug, while Johnson & Johnson Pharmaceutical R&D will be responsible for all additional testing of the compound.