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Metabolex Announces Positive Results From Phase 1a Clinical Trial of MBX-2982
Date:11/12/2008

Results Presented at CODHy Conference

HAYWARD, Calif., Nov. 12 /PRNewswire/ -- Metabolex, Inc., a biopharmaceutical company focused on the discovery and development of proprietary new medicines for the treatment of metabolic diseases, announced positive results from a Phase 1a clinical trial of MBX-2982. A summary of the results was presented at the World Congress on Controversies to Consensus in Diabetes, Obesity and Hypertension (CODHy) on November 1, 2008.

MBX-2982 is a potential first-in-class treatment for type 2 diabetes that targets G protein-coupled receptor 119 (GPR119), a receptor that interacts with bioactive lipids known to stimulate glucose-dependent insulin secretion. Preclinical data indicate that MBX-2982 is a potent selective orally active GPR119 agonist that functions through a unique dual mechanism of action. First, it acts directly on the beta cell to increase insulin secretion. In addition, MBX-2982 stimulates release of the incretin GLP-1 from the gut. This dual action is unique and may offer improved glucose homeostasis over existing diabetes therapies, with potential for weight loss and improved islet health.

The Phase 1a study was a randomized, placebo-controlled, double-blind, ascending-dose clinical trial in 60 healthy male and female volunteers examining doses of MBX-2982 in the 10 - 1000 mg range. All doses of the drug were well tolerated and no dose-related adverse events were observed. MBX-2982 was rapidly absorbed, demonstrated excellent exposure and exhibited a half- life consistent with once-daily dosing. As observed in preclinical studies in animals, MBX-2982 showed dose-dependent reductions in glucose and increases in GLP-1 following a mixed meal. These results provide initial clinical validation of the unique mechanism of action of MBX-2982.

"The results of this Phase 1a clinical trial are very encouraging and support the continued development of MBX-2982 as an important new therapy for treating type 2 diabetes," said Harold Van Wart, Ph.D., Chief Executive Officer of Metabolex. "Based on the excellent safety profile and encouraging effects on glucose levels observed in our Phase 1a trial, we have advanced MBX-2982 into a Phase 1b study in which we are evaluating the multiple-dose pharmacokinetics and pharmacodynamics."

"We are now focusing our earlier stage research and development programs on GPCR targets," stated Chuck McWherter, Senior Vice President of Research and Preclinical Development at Metabolex. "The positive results from our GPR119 program demonstrate the utility of this approach which emphasizes innovative GPCR-based strategies for the development of treatments for serious unmet medical needs."

About MBX-2982

MBX-2982 is an agonist of GPR119, a GPCR that is expressed in pancreatic islets and the gastrointestinal tract. Pre-clinical studies conducted by Metabolex and others show that GPR119 agonists can stimulate glucose-dependent insulin secretion and release of incretin hormones such as GLP-1, and thus may preserve beta cell health. This novel dual mechanism may provide a unique therapeutic benefit in the treatment of type 2 diabetes. Additionally, the stimulation of GLP-1 release may mimic the benefits of incretin analogues such as exenatide (a GLP-1 analogue marketed as Byetta(R)). Unlike exenatide, however, MBX-2982 can be delivered orally.

About Diabetes

Diabetes is a worldwide health problem and a rapidly growing source of illness, death and health care costs. According to the International Diabetes Federation, approximately 246 million adults, or 6 percent of the world's adult population, had diabetes in 2007. The American Diabetes Association (ADA) estimates that there were approximately 23.5 million adults in the United States with diabetes in 2007, making up 10.7 percent of the adult population. According to estimates from the ADA, one in ten health care dollars is attributed to diabetes. Type 2 diabetes accounts for 90 to 95 percent of diabetic cases.

About Metabolex

Metabolex is a privately-held biopharmaceutical company focused on the discovery and development of proprietary new medicines for the treatment of metabolic diseases, with an emphasis on type 2 diabetes. The company has four clinical-stage compounds: MBX-102/JNJ 39659100, which has completed three Phase 2 trials; MBX-2044, which has completed a Phase 2a trial; MBX-8025, which recently completed a Phase 2 trial in patients with dyslipidemia; and MBX-2982, which recently completed a Phase 1 trial. Ortho-McNeil, Inc. has the exclusive right to develop and commercialize MBX-102/JNJ 39659100. For additional information about Metabolex and its development pipeline, visit http://www.metabolex.com


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