MOUNTAIN VIEW, Calif., June 8, 2012 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc. (CCXI) announced today publication of positive data from the Company's Phase 2 CARAT-2 study for CCX354, a potent and selective, orally-administered inhibitor of CCR1, a chemokine receptor that drives the recruitment of inflammatory cells into the joints of patients with rheumatoid arthritis (RA). The findings showed that CCX354 was generally well tolerated by patients with RA. Measurement of evidence of clinical activity included the ACR20 response at Week 12 in patients who met trial inclusion criteria at the start of dosing (Day 1 eligible): The response was 56% in patients receiving 200 mg CCX354 once daily, compared to 44% in patients receiving 100 mg twice daily and 30% in patients receiving placebo. ACR20 is a standard measure of improvement in tender and swollen joint counts. The difference between 200 mg once daily and placebo was statistically significant (p=0.014). Data also indicated that CCX354 treatment reduced markers of bone turnover, supporting the previously documented role of CCR1 in osteoclast maturation and migration.
The CARAT-2 clinical data, which were first presented and announced in 2011 at the American College of Rheumatology, are now available in an online article in the Annals of the Rheumatic Diseases titled, "Chemokine receptor CCR1 antagonist CCX354-C treatment for rheumatoid arthritis: CARAT-2, a randomised, placebo controlled clinical trial" (http://ard.bmj.com/content/early/2012/05/14/annrheumdis-2011-201605.abstract). The findings also will be presented in an oral presentation titled, "Orally Administered CCR1 Antagonist CCX354-C in Phase 2 Rheumatoid Arthritis Study," on June 9th at the Annual European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology being held in Berlin.
"Results from the CARAT-2 study have demonstrated clinical proof-of-concept of CCR1 inhibition in the treatment of RA," stated Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "Through this program, we believe we have significantly advanced the understanding of this important disease target, building on more than two decades of scientific research regarding the role of CCR1 in inflammatory diseases."
CARAT-2 Study Design
This 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. Enrolled patients had moderate to severe RA, were on stable methotrexate treatment for at least 8 weeks, had at least 8 swollen and tender joint counts, and CRP at least 5 mg/L at study entry. Patients were randomized to 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.
About CCX354 and Rheumatoid Arthritis
CCX354 has been shown to be a potent and selective antagonist of CCR1, a chemokine receptor that drives the recruitment of certain inflammatory cells including populations of monocytes, macrophages and T cells 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, thus inhibiting the inflammation, swelling, pain and associated joint destruction while minimizing the potential for off-target effects. RA is estimated to affect more than two million people in the U.S. and is a leading cause of morbidity, disability and reduced work ability. The exact cause of RA is unknown, but is believed to reflect the body's immune system attack on the synovium, the tissue that lines the joints. Despite available treatments, there remains a significant unmet medical need for better therapies for RA.
ChemoCentryx recently announced that GlaxoSmithKline (GSK) has exercised its option to exclusively license CCX354.
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. The Company's most advanced drug candidate, vercirnon (also known as Traficet-EN, CCX282 or GSK1605786), 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. The Company's lead independent drug candidate, CCX140, 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 (also known as GSK2941266), a CCR1 inhibitor which successfully completed a Phase II clinical trial for the treatment of rheumatoid arthritis, and CCX168, a C5aR inhibitor in Phase II clinical development for the treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis. ChemoCentryx also has several programs in advanced preclinical development.
ChemoCentryx cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "may," "could," "will," "would," "should," "expect," "plan," "anticipate," "believe," "estimate," "intend," "predict," "seek," "contemplate," "potential" or "continue" or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. These statements are based on the Company's current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by ChemoCentryx that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risk and uncertainties inherent in the ChemoCentryx business and other risks described in the Company's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and ChemoCentryx undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading "Risk Factors" in ChemoCentryx's periodic reports filed with the Securities and Exchange Commission ("SEC"), including ChemoCentryx's Annual Report on Form 10-K for the year ended December 31, 2011 and Quarterly Report on Form 10-Q for the three-month period ended March 31, 2012, which are available from the SEC's website (www.sec.gov) and on ChemoCentryx's website (www.ChemoCentryx.com) under the heading "Investors." All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
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