ChemoCentryx Initiates a Phase II Clinical Trial For CCX140, A Novel Inhibitor of the Chemokine Receptor CCR2 for the Treatment of Diabetic Nephropathy

MOUNTAIN VIEW, Calif., Dec. 8, 2011 /PRNewswire/-- 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."

Trial Design

The randomized, double-blind placebo controlled Phase II study is designed to evaluate the safety and tolerability of CCX140 in subjects with diabetic nephropathy. Other objectives are to study the efficacy of CCX140 versus placebo in changes from baseline in urinary albumin to creatinine ratio (ACR) and HbA1c. The trial is expected to enroll at least 135 subjects randomized to one of three treatment groups: placebo, 5 mg or 10 mg CCX140 once daily for a treatment duration of 12 weeks with a four-week follow-up period. Following an interim analysis for efficacy evaluation, the sample size may be increased to up to 270 patients, and/or dose groups may be added.

About ChemoCentryx

ChemoCentryx, Inc. is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing orally-administered therapeutics that target the chemokine and chemoattractant systems in order to treat autoimmune diseases, inflammatory disorders and cancer. The chemokine system is a biological network that regulates inflammation via a collection of secreted chemokine molecules, or ligands, and their specific cell surface receptors. Based on its proprietary drug discovery and drug development platform, ChemoCentryx has generated multiple clinical and preclinical-stage programs, each targeting distinct chemokine and chemoattractant receptors with different small molecule compounds. ChemoCentryx's most advanced drug candidate, CCX282-B (Traficet-EN, now designated GSK1605786, also known as GSK'786), a specific CCR9 inhibitor, completed a multi-national clinical trial, called PROTECT-1, in patients with moderate-to-severe Crohn's disease, where it demonstrated the ability to induce a clinical response and to maintain clinical remission, and is now in Phase III clinical development. ChemoCentryx's lead independent drug candidate, CCX140-B, a CCR2 inhibitor, has been shown to be safe and well tolerated while demonstrating clinical activity on glycemic indices in a Phase II clinical trial in type 2 diabetics, and is now in Phase II clinical development for the treatment of diabetic nephropathy. Other clinical programs include CCX354, a CCR1 inhibitor which successfully completed a Phase II clinical trial for the treatment of rheumatoid arthritis; CCX168, a C5aR inhibitor, in Phase II clinical development for the treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis; and CCX832, a ChemR23 antagonist in Phase I clinical development. ChemoCentryx also has several programs in advanced preclinical development.

Certain statements in this press release may constitute "forward-looking statements". These statements are made on the basis of current expectations, forecasts and assumptions that involve risks and uncertainties, including, but not limited to, economic, competitive, governmental and technological factors outside of our control, that may cause our business, strategy or actual results to differ materially from those expressed or implied. We do not intend, and undertake no obligation, to update any forward-looking statements, whether as a result of new information, future events or otherwise.

SOURCE ChemoCentryx, Inc.