ChemoCentryx, Inc. today announced that CCX140, the Company's novel, orally active CCR2 antagonist successfully met its primary endpoint of safety and tolerability and demonstrated clinical efficacy in a Phase II study in patients with type 2 diabetes on stable doses of metformin. These data were presented today in San Diego at the 71st Annual Scientific Session of the American Diabetes Association in an oral presentation entitled "Oral Chemokine Receptor 2 Antagonist CCX140-B Shows Safety and Efficacy in Type 2 Diabetes Mellitus". While demonstrating safety and tolerability, a statistically significant decrease in hemoglobin A1c (HbA1c) relative to placebo and a dose-dependent lowering of fasting plasma glucose were shown following only 28 days of treatment of CCX140. CCX140 is poised to enter Phase II clinical development for the treatment of diabetic kidney disease in 2011.
"We are very pleased with the favorable results achieved by administering CCX140 in type 2 diabetic patients, since this is the population in which we plan to further evaluate the drug in a Phase II trial in patients with diabetic nephropathy," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "These results continue to validate CCX140 as a best-in-class molecule that is highly differentiated from other products in development and those currently marketed by its potential to treat complications that are an inevitable consequence of suffering from diabetes, such as chronic kidney disease. The large unmet need associated with chronic kidney disease represents an ideal opportunity for CCX140 and we look forward to moving this drug through clinical development."
Results showed that daily treatment with CCX140 was effective, safe and well tolerated. Additionally, daily treatment with CCX140 showed a dose-dependent decrease in fasting plasma glucose through week 4. A significant decrease in HbA1c was observed after only 4 weeks of daily treatment of CCX140 (10 mg) compared to placebo (p = 0.045). No detrimental effects were observed on plasma MCP-1 or blood monocyte levels, and once daily oral CCX140 provided excellent plasma coverage.