ChemoCentryx Reports CCX140, a Novel Oral CCR2 Antagonist, Demonstrates Clinical Activity on Glycemic Indices in a Phase II Study in Type 2 Diabetes
"Data Presented at the 71st Annual Scientific Session of the American Diabetes Association"
MOUNTAIN VIEW, Calif., June 27, 2011 /PRNewswire/ -- 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.
Trial Design and CCX140
This was a multinational, randomized, double-blind, placebo and active-controlled clinical trial in 159 patients with type 2 diabetes on stable doses of metformin. HbA1c was 6.5 to 10% and fasting plasma glucose 135 to 270 mg/dL at study entry. Randomized subjects received double-blind placebo QD, 5 mg CCX140 QD, 10 mg CCX140 QD, or open label pioglitazone 30 mg QD for 4 weeks. The average age was 59 years and 64% of the participants were male. Mean body mass index was 32 kg/m2 and diabetes duration was 5.8 years (median).
CCX140 is chemically distinct from all other known antagonists of CCR2 and works by blocking the infiltration and activation of certain populations of monocyte/macrophages and other cells bearing CCR2 that occurs during inflammation and thus is designed to provide selective treatment of the disease without compromising other immune functions.
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 lead compound, CCX282 (Traficet-EN, now designated GSK1605786, also known as GSK'786), a specific CCR9 antagonist, 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. CCX140, a CCR2 antagonist, 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 diabetes. CCX140 is poised to enter Phase II clinical development for the treatment of diabetic nephropathy. Other clinical programs include CCX354, a CCR1 antagonist in a Phase II clinical trial for the treatment of rheumatoid arthritis; CCX168, a C5aR antagonist, that completed Phase I clinical development and is anticipated to enter Phase II clinical trials in 2011; and CCX832, a ChemR23 antagonist in Phase I clinical development. ChemoCentryx also has several programs in advanced preclinical development. ChemoCentryx is privately held. For more information, please refer to www.chemocentryx.com.
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.
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