Metabolex, Inc.

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Targeting Mixed Dyslipidemia and Metabolic Syndrome
The world-wide obesity epidemic has fueled an increase in a number of metabolic disorders including various forms of dyslipidemia, metabolic syndrome, type 2 diabetes and non-alcoholic steatohepatitis (NASH). Over 100 million adults in the US have some form of lipid disorder.

MBX-8025 is in development as a first-in-class treatment that effectively addresses all three lipid disorders associated with mixed dyslipidemia as well as a majority of the cardiovascular risk factors that define metabolic syndrome. Patients with mixed dyslipidemia have an atherogenic lipid profile characterized by elevated levels of low density lipoprotein cholesterol (LDL), suppressed levels of high density lipoprotein cholesterol (HDL) and elevated triglycerides (TGs).

Metabolex has recently completed a thorough Phase 2 proof-of-concept study that shows that MBX-8025 effectively addresses each of the lipid abnormalities associated with mixed dyslipidemia. In addition, MBX-8025 addresses other aspects of metabolic disorders including: improvements in insulin sensitivity, trends toward decreased waist circumference and body fat, anti-inflammatory activity, and improved surrogate markers of liver health. This exceptional spectrum of beneficial effects makes MBX-8025 a very attractive new product candidate for dyslipidemia and metabolic syndrome.

MBX-8025 targets the peroxisomal proliferator-activated receptor delta (PPAR-delta), a nuclear transcription factor that regulates genes involved in lipid storage and transport (particularly in fatty acid oxidation) and insulin signaling and sensitivity. MBX-8025 is a potent selective agonist of the human PPAR-delta receptor. The compound, formerly RWJ-800025, was in-licensed from Janssen Pharmaceutica NV as part of a transaction in which Metabolex out-licensed its lead insulin sensitizer, MBX-102, to Johnson & Johnson.