Metabolex, Inc.

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Novel Compound, Novel Safety Profile

MBX-102 (formerly known as metaglidasen) addresses insulin resistance, the underlying cause of type 2 diabetes, by modulating genes responsible for insulin sensitization. MBX-102 is also a potent uricosuric agent. Currently marketed insulin sensitizers from the thiazolidinedione, or TZD, class carry black box warnings of increased risk of congestive heart failure due to edema and cause significant weight gain, which compromises patient compliance.

Clinical Development

A 200-patient Phase 2 study of MBX-102 is in progress which is evaluating two doses of the drug compared with pioglitazone (a TZD) in patients receiving concomitant metformin therapy. The trial will assess the ability of MBX-102 to control hemoglobin A1c (HbA1c) levels – the gold-standard measure of a patient’s blood glucose control over time. Earlier clinical results in insulin-treated patients with diabetes showed MBX-102 was well tolerated and lowered blood glucose, triglycerides and uric acid levels without causing any increase in weight gain or edema.

Unique Clinical, Preclinical and Gene Expression Profile

MBX-102 has a different chemical structure and mechanism of action than the insulin sensitizers currently on the market. Unlike those drugs, MBX-102 is not a TZD. Drugs from the TZD class modulate the genes responsible for insulin sensitivity and those linked to adipogenesis and fluid retention, causing weight gain and edema. MBX-102, in contrast, selectively modifies gene expression needed for insulin sensitization without activating the genes responsible for weight gain and edema, and it does not appear to cause those adverse events in the preclinical and clinical studies completed to date.