Metabolex Begins Phase 2 Trial Of MBX-8025 For Treatment Of Dyslipidemia

Metabolex, Inc., a
biotechnology company dedicated to the discovery and development of novel
therapeutics for diabetes and related metabolic disorders, announced
that it has begun a 180 patient Phase 2 trial of MBX-8025 in overweight or
obese patients with high cholesterol and triglycerides to assess the drug's
effect on dyslipidemia, insulin-resistance and obesity.


Preclinical and clinical testing of MBX-8025 indicates that the drug
has the potential to improve a number of lipid parameters that are abnormal
in different types of dyslipidemia, including high LDL (or "bad")
cholesterol, high Apo B-100 (the atherogenic lipoprotein), low HDL (or
"good") cholesterol and high triglycerides (fats). In addition, MBX-8025
has been shown to exhibit positive effects on insulin sensitization and
body weight. The randomized, double blind Phase 2 trial will assess the
potential of the drug alone and in combination with Lipitor(R)
(atorvastatin).



"Although high LDL levels are widely treated as a risk factor for heart
disease, many patients are unable to reach increasingly low LDL targets on
a statin alone. Additionally, existing drugs do a poor job of targeting the
entire range of different lipid disorders that contribute to cardiac risk.
We believe this trial will provide us crucial evidence in assessing the
ability of MBX-8025 to lower Apo B-100, LDL and triglyceride levels, as
well as raise HDL levels, improve insulin sensitivity and reduce body
weight," said David B. Karpf, M.D., the chief medical officer of Metabolex.
"In addition, we are testing the drug in conjunction with Lipitor, the
best-selling lipid-lowering drug in the world, to determine whether
combination therapy with a statin will be well tolerated and lead to even
better results."



The study will enroll 180 overweight or obese non diabetic patients and
assess two different doses of MBX-8025, given over an 8-week treatment
period, both alone and in combination with Lipitor(R). The primary endpoint
is the reduction in Apo B-100 compared with placebo. Secondary endpoints
include measurements of the effect of treatment on LDL, HDL, triglycerides
and body weight and composition. Metabolic parameters, including glucose
and insulin levels, will also be assessed.



MBX-8025 regulates fatty acid degradation, lipid storage/transport and
insulin sensitivity. Metabolex has in-licensed the patents and the
exclusive development and commercialization rights to MBX-8025 from Janssen
Pharmaceutica NV, a Johnson & Johnson company.



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, now in Phase 2. 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 metabolex.


Metabolex, Inc.

metabolex