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