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ChemoCentryx, Inc.
today 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 (i.e.,
stable doses of angiotensin pathway inhibitors), 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 (UACR) versus those patients
receiving only the standard of care (placebo group), following two weeks of
treatment (total study number, n, analyzed at that time point = 332; p<0.05),
with continuing downward trends in UACR observed following 8-weeks (n=259) and
12-weeks (n=208) 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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