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ChemoCentryx Reports Clinical Efficacy for CCX354, a Novel CCR1 Inhibitor in a Phase II Study in Patients with Rheumatoid Arthritis
Date:11/8/2011

pared to placebo at Week 12 (p=0.023).  ACR50, ACR70, DAS28-CRP, and ACR component results indicated greatest efficacy in the 200 mg daily dose group.  Decreases in bone turnover markers C-telopeptide (CTx), procollagen type I N-terminal propeptide (PINP), and osteocalcin were more pronounced in the CCX354-C groups compared to placebo, and reaching statistically significant improvements at many time points during the study. Clinical responders had higher plasma CCX354 concentrations than non-responders.  CCX354 was well tolerated by patients in this study.

Study DesignThis Phase II study named CARAT-2 (CCR1 Antagonist in Rheumatoid Arthritis Trial-2) was a 160-patient multinational, randomized, double-blind, placebo-controlled RA clinical trial.  Patients had moderate to severe RA, were on stable methotrexate treatment for at least 8 weeks, had >/= 8 swollen and tender joint counts, and CRP >/= 5 mg/L at study entry.  Patients received double-blind placebo twice daily (N=54), 100 mg CCX354 twice daily (N=53) or 200 mg CCX354 once daily (N=53) orally for 12 weeks.  Safety and tolerability were primary endpoints, and secondary endpoints included RA disease response measurements:  ACR, DAS28, CRP, and ESR, as well as bone turnover markers, CTx, PINP, and osteocalcin.

CCX354 and Rheumatoid Arthritis (RA)CCX354 is a potent and selective antagonist of CCR1, a chemokine receptor that drives the recruitment of certain inflammatory cells including populations of monocytes and macrophages into the joints of patients with RA.  By selectively blocking the CCR1 receptor, CCX354 is designed to reduce the infiltration of inflammatory cells into the joints of RA patients and inhibiting the inflammation, swelling, pain and associated joint destruction while minimizing the potential for off-target effects, thus providing a wider therapeutic window than currently approved thera
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SOURCE ChemoCentryx, Inc.
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