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September 10, 2013
07:04 EDTCCXIChemoCentryx says interim data support continued dosing in Phase II study
ChemoCentryx announced interim data from an ongoing Phase II study in patients with diabetic nephropathy, also known as diabetic kidney disease, with CCX140. CCX140 is an inhibitor of the chemokine receptor known as CCR2, and the drug candidate is wholly owned by the company. Examining data through the first 12 weeks of dosing in the ongoing 52 week trial, in which CCX140 is added on top of the standard of care for diabetic nephropathy patients, the drug candidate appears well-tolerated in the patient population to date. The safety observations were consistent with a concurrent analysis by the company's independent safety data monitoring committee, which independently assessed the interim data and recommended no changes to the ongoing study protocol. In addition, data also showed that patients treated with 5 mg CCX140 once daily experienced a statistically significant reduction of protein in the urine, or proteinuria, as measured by Urinary Albumin Creatinine Ratio versus those patients receiving only the standard of care, following two weeks of treatment, with continuing downward trends in UACR observed following 8-weeks and 12-weeks of treatment with CCX140. In pre-specified analyses of subsets of patients in the study, greater reductions in proteinuria were observed, including decreases of approximately 30% in UACR in the CCX140 groups versus those patients only on background medications. The company indicated that the data support the continued progress of full 52 weeks of dosing in the Phase II trial as planned. Data from the full study are expected in the second half of 2014, which will continue to monitor proteinuria as well as assess additional markers related to kidney function, including serum creatinine and estimated glomerular filtration rate, measures which historically take longer to be detected in clinical trials.
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