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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
generic fosamax online buy MBX-102/JNJ 39659100. For additional information about Metabolex and its
development pipeline, visit
Metabolex

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