MOUNTAIN VIEW, Calif., Nov. 17, 2014 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq:CCXI), a clinical-stage biopharmaceutical company focused on autoimmune diseases, inflammatory disorders and cancer, today reported additional data from a Phase II clinical trial (the CLEAR trial) with CCX168, an inhibitor targeting the receptor for the complement protein known as C5a (C5aR), in anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). Dr. David Jayne from Addenbrooke's Hospital in Cambridge, UK, Principal Investigator of the study, delivered an oral presentation at the American College of Rheumatology (ACR) Annual Meeting in Boston, MA, taking place from November 14-19, 2014.
In today's presentation, previously unreported BVAS (for Birmingham Vasculitis Activity Score, an index of ANCA disease activity) response and remission data from the first two steps of the CLEAR trial were presented, for both the renal and non-renal components of the scores (see table below for details). The BVAS index is an important indicator of systemic health in these patients and includes an assessment in nine body systems (general health, cutaneous, mucous membranes/eyes, eyes, nose and throat, chest, cardiovascular, abdominal, renal and nervous system), many of which are non-renal.
Patients in both groups who received CCX168 showed marked improvements in BVAS response (a decrease in BVAS denotes an improvement in disease) at 12 weeks in the renal as well as non-renal components of the score, and these responses were higher than those receiving standard of care. Similarly, BVAS remission (a higher threshold that is thought to require 24 weeks of treatment or longer for maximum effect) at 12 weeks for the non-renal disease component was greater in the CCX168 treatment groups than the standard of care group and similar for the renal component.
"Improvement with CCX168 treatment in the non-renal manifestations of ANCA-associated vasculitis, in addition to the kidney aspect of this disease, is particularly intriguing, and highlights a potential broader role for a C5aR inhibitor such as CCX168 in treating AAV patients, not just with renal disease, but also with non-renal disease," said Pirow Bekker, M.D., Ph.D., Chief Medical Officer, ChemoCentryx, Inc. "Also, improvement in the safety profiles of drugs given to these patients is important, especially given the toxicities associated with current treatment options for AAV patients."
|
Mean (SEM) % Change From Start of Study to Week 12 |
CCX168 + CYC + No Steroids (N=8) |
CCX168 + Cyclophosphamide (CYC) + Low-Dose Steroids (N=8) |
Standard of Care: CYC + High-Dose Steroids (N=9) |
| BVAS Total | -65% | -71% | -26% |
| Renal | -50% | -64% | -16% |
| Non-renal | -83% | -81% | -15% |
| % of Patients BVAS Response* | |||
| Renal | 50% | 71% | 38% |
| Non-renal | 88% | 83% | 57% |
| % of Patients BVAS Remission** | |||
| Renal | 25% | 29% | 25% |
| Non-renal | 50% | 67% | 43% |
* Response: BVAS decrease of at least 50% plus no worsening in any body system
** Remission: BVAS of 0 plus prednisone dose less than or equal to 10 mg/day
Promising data from the first two steps of the CLEAR trial were announced in December 2013. CCX168 appeared to be safe, well tolerated and successful in allowing both reduction and elimination of high-dose corticosteroids, part of standard of care for AAV patients, without compromising efficacy or safety during a 12-week treatment period. Furthermore, data were presented demonstrating treatment with CCX168 showed greater improvements consistently across a number of renal health parameters, including renal remission, albuminuria, and urinary MCP-1 compared to standard of care treatment alone. In June 2014, data were presented demonstrating that patients receiving CCX168 showed improvements in the BVAS Total score.
Presentation Information
ACR Oral Presentation Abstract #1863 November 17, 2014 3:15 to 3:30 p.m. ET
"CCX168, an Orally Administered C5aR Inhibitor for Treatment of Patients with Antineutrophil Cytoplasmic Antibody-Associated Vasculitis"
About the CCX168 Phase II CLEAR Trial
The CLEAR trial is a randomized, double-blind, placebo-controlled, three-step Phase II trial being conducted at multiple study centers in Europe. The clinical trial is designed to determine whether CCX168 can partially replace or potentially eliminate full-dose corticosteroids in patients with ANCA-associated vasculitis, a desirable outcome given the toxicities of high-dose corticosteroid use. Patients are currently being enrolled in the third step of the CLEAR trial.
ChemoCentryx has commenced clinical site initiations for a second Phase II clinical trial with CCX168 in North America in patients with AAV (the CLASSIC trial).
CCX168 targets the complement C5a receptor, or C5aR, which binds to a biologically activated fragment of the complement protein known as C5a. C5aR is thought to play a role in a range of inflammatory and autoimmune diseases, such as AAV and other renal diseases such as atypical hemolytic uremic syndrome and IgA nephropathy.
About ANCA-Associated Vasculitis (AAV)
ANCA-associated vasculitis (AAV) is a rare, severe, often fatal autoimmune disease that is caused by autoantibodies called anti-neutrophil cytoplasmic antibodies (ANCA). AAV is characterized by inflammation that can affect many different organs and areas of the body, such as eyes, lung, sinuses, nerves and the kidney.
The annual incidence and prevalence of AAV in Europe and the United States is estimated to be approximately 10 cases per million people per year and 100 per million people, respectively.
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. 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. CCX168, a C5aR inhibitor, is in Phase II development for the treatment of anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV). CCX168 appears to be safe, well tolerated and successful in allowing both reduction and elimination of high-dose corticosteroids, part of standard of care for AAV patients, without compromising efficacy or safety during a 12-week treatment period. Vercirnon (also known as Traficet-EN or CCX282) is a specific CCR9 inhibitor for the treatment of inflammatory bowel disease. Other clinical programs include CCX872, a next generation CCR2 inhibitor currently in Phase I clinical development, CCX507, a next generation CCR9 inhibitor, which has successfully completed Phase I development and CCX354, a CCR1 inhibitor which successfully completed a Phase II clinical trial for the treatment of rheumatoid arthritis. ChemoCentryx also has several programs in advanced preclinical development.
Forward-Looking Statements
ChemoCentryx cautions 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. 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 risks and uncertainties inherent in the ChemoCentryx business and other risks described in the Company's filings with the Securities and Exchange Commission ("SEC"). Investors 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 SEC, including ChemoCentryx's Quarterly Report on Form 10-Q filed with the SEC August 8, 2014 and its other reports 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 the Private Securities Litigation Reform Act of 1995.
Source: ChemoCentryx (CCXI-G)