Type 2 diabetes is now a global epidemic. However, drugs to treat diabetes are inadequate and generally have dose limiting side effects. We seek to address the epidemic with superior drugs based on a better understanding of the disease.
   
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Novel Compound, Novel Safety Profile
MBX-102/JNJ-39659100 (formerly known as metaglidasen) addresses insulin resistance, the underlying cause of type 2 diabetes, by modulating genes responsible for insulin sensitization. The 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.
Based on promising gene expression data, preclinical research and clinical findings, we and our development partner Ortho-McNeil have pursued development of MBX-102 to address the shortcomings of currently marketed therapies, particularly edema and weight gain. Phase 1 and 2 clinical testing of MBX-102 suggests it may have comparable efficacy with an improved safety profile.
Clinical Development
We are in the process of commencing a 200-patient Phase 2 study of MBX-102 that 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.
Large Market Potential
MBX-102 has the potential to capture a large share of the global market for oral diabetes agents. In particular, a drug with its profile could become best-in-class in the $6 billion insulin sensitizers market. Addressing insulin resistance can treat and potentially prevent the onset of type 2 diabetes, yet concerns about the adverse effect profile of the currently marketed insulin sensitizers has limited their use, particularly in the prevention market.