ChemoCentryx, Inc. today announced the initiation of a Phase II clinical trial for CCX140, an orally-administered small molecule for the treatment of diabetic kidney disease (diabetic nephropathy). CCX140 is a novel CCR2 inhibitor with a pharmacological profile unlike that of other CCR2 compounds that have been known to be tested by other sponsors. CCX140 works by blocking the infiltration and activation of certain populations of monocyte and macrophages and other cells bearing CCR2 that occurs during inflammation. This mechanism of action provides selective treatment of the disease without compromising other immune functions.
As a precursor to the recently initiated clinical trials for CCX140 in patients with diabetic nephropathy, in an earlier Phase II clinical trial, ChemoCentryx assessed the safety, tolerability and clinical effects of CCX140 in type 2 diabetics with normal kidney function. In that trial, CCX140 demonstrated clinical efficacy and successfully met its primary endpoint of safety and tolerability in type 2 diabetics on stable doses of metformin. Specifically, 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 with CCX140. Additionally, ChemoCentryx's CCR2 inhibitors have shown to significantly improve kidney function and hyperglycemia in preclinical models of diabetic nephropathy in addition to those for type 2 diabetes.
"Previously we showed that CCX140 could be used in patients with type 2 diabetes in a clinical trial where it was safe and well tolerated and demonstrated the ability to control glycemic indices. Upon successful completion of the Phase II program in diabetic nephropathy with CCX140, our lead independent drug candidate, we plan to expeditiously initiate Phase III clinical development," stated Thomas Schall, Ph.D. President & Chief Executive Officer, ChemoCentryx. "Driving the development and commercialization of CCX140 is an important element of the Company's corporate strategy to forward integrate into a commercial biopharmaceutical company."