HAYWARD, Calif., June 16 /PRNewswire/ -- Metabolex, Inc., a biopharmaceutical company focused on the discovery and development of proprietary new medicines for the treatment of metabolic diseases, announced today that it has completed enrollment in a 180-patient Phase 2 trial of MBX-8025 in overweight or obese patients with high cholesterol and triglycerides.
The randomized, double-blind study is designed to assess the drug's effect on dyslipidemia and insulin resistance, and will evaluate two different doses of MBX-8025 given over an 8-week period, both alone and in combination with Lipitor(R) (atorvastatin). The primary endpoint is the reduction in Apo B-100, the atherogenic lipoprotein in LDL (low-density lipoprotein), compared to placebo. Secondary endpoints include measurements of the effect of treatment on LDL, HDL (high-density lipoprotein), triglycerides and body weight and composition. Metabolic parameters, including glucose and insulin levels and insulin sensitivity, are also being assessed.
"America is suffering from an epidemic of obesity and its consequences, one of which is mixed dyslipidemia. Patients with this type of dyslipidemia have elevated LDL cholesterol, but also have elevated triglycerides, low HDL levels, and have a large amount of small, dense LDL particles, which are much more atherogenic," said David B. Karpf, M.D., the chief medical officer of Metabolex. "Statins do a good job of lowering LDL, but are not fully effective because they do not treat the other aspects of mixed dyslipidemia. This enrollment milestone puts us one step closer to understanding the ability of MBX-8025 to treat mixed dyslipidemia, as well as providing preliminary evidence of the drug's ability to enhance insulin sensitivity and reduce body weight -- two additional features of metabolic syndrome."
A growing body of research indicates that cardiac risk is affected by a number of different compounds in the blood, including high levels of LDL, or bad cholesterol, low levels of HDL, or good cholesterol, and high triglyceride levels -- known collectively as mixed dyslipidemia. Though some drugs have marked effects on some of these parameters, existing treatments do not optimally treat all elements of this common condition.
Earlier testing of MBX-8025 has suggested that the drug has the potential to improve a number of different lipid parameters, and because the mechanism of action differs from already-marketed cholesterol-lowering agents such as statins, MBX-8025 may be ideally suited to combination therapy. The drug may also have an effect on insulin sensitivity and body weight, which could further boost its utility in treating the constellation of symptoms known as metabolic syndrome.
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. Metabolex has drawn on its deep understanding of diabetes to create a large database of genes involved in diabetes and to build a rich pipeline of product candidates and drug discovery targets. 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, currently being studied in a Phase 2 trial in patients with dyslipidemia; and MBX-2982, currently being studied in 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.
|SOURCE Metabolex, Inc.|
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