Metabolex Announces Full Enrollment Of Phase 2/3 Study Of MBX-102/JNJ 39659100 In Patients With Type 2 Diabetes

Main Category: Diabetes
Also Included In: Clinical Trials / Drug Trials
Article Date: 20 Jul 2007 - 0:00 PDT

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Metabolex, Inc., a biotechnology company dedicated to the discovery and development of novel therapeutics for diabetes and related metabolic disorders, announced that it has completed enrollment in the 400-patient Phase 2/3 study of its novel insulin sensitizer, MBX-102/JNJ 39659100, in patients with type 2 diabetes. Metabolex will receive a milestone payment from Ortho-McNeil, Inc., which holds an exclusive license for worldwide development and commercialization of MBX-102/JNJ 39659100.

"We have had great success in recruiting patients into the trial, which is a testament to the promise of our approach and the efforts of our investigators," said Harold Van Wart, Ph.D., Metabolex's president and chief executive officer. "Our clinical team is now working to ensure the patients in the trial are well monitored, and we expect to share the results early next year, when all patients have completed the 16-week trial and we have examined the data."

The randomized, double-blind, placebo- and active comparator-controlled, multicenter Phase 2/3 trial is evaluating MBX-102/JNJ 39659100 at daily doses of 200, 400 and 600 mg versus Actos(R) (pioglitazone, a thiazolidinedione -- TZD -- drug) 30 mg in patients with type 2 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 2 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.

In addition, preclinical work has shown that MBX-102/JNJ 39659100 may have potent anti-inflammatory activity. Inflammation has been linked to the development of insulin resistance and type 2 diabetes, suggesting an additional mechanism by which MBX-102/JNJ 39659100 may control the disease process in diabetes.

In June 2006, Metabolex entered into a strategic alliance with Ortho-McNeil, Inc., giving Ortho-McNeil an exclusive license for worldwide development and commercialization of MBX-102/JNJ 39659100. Metabolex is conducting the Phase 2/3 trial of MBX-102/JNJ 39659100; Johnson & Johnson Pharmaceutical Research & Development, L.L.C. will be responsible for all additional testing of the compound.

About Metabolex

Metabolex is a privately held biotechnology company dedicated to the discovery and development of novel therapeutics to transform the treatment of diabetes and related metabolic disorders. Metabolex has drawn on its deep understanding of diabetes to create the largest database of genes involved in diabetes and to build a rich pipeline of product candidates and drug discovery targets. The company has three clinical-stage compounds: MBX-102/JNJ 39659100, in Phase 2/3 testing; MBX-2044, in Phase 2a; and MBX-8025, being studied in dyslipidemia, which has completed Phase 1 studies. Ortho-McNeil, Inc. has the exclusive right to develop and commercialize MBX-102/JNJ 39659100 and MBX-2044. For additional information about Metabolex and its development pipeline, visit http://www.metabolex.com.

Metabolex, Inc.
http://www.metabolex.com