ChemoCentryx Announces Top-Line Interim Results for CCX140,
ChemoCentryx Announces Top-Line Interim Results for CCX140,
an Orally Administered CCR2 Inhibitor, in an Ongoing 52 Week
Phase II Trial in Patients With Diabetic Nephropathy
MOUNTAIN VIEW, Calif., Sept. 10, 2013 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc. (Nasdaq:CCXI) 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.
"We're encouraged that the interim analysis provides support for the 52 week clinical trial design, and early clinical validation of our approach of inhibiting the chemokine receptor CCR2 in kidney disease,"
said Thomas J. Schall, PhD, President and Chief Executive Officer of ChemoCentryx. "The 12-week data are particularly interesting in the patient population that most closely mimics several preclinical in vivo mechanism models we tested. Not only is it gratifying to see observations gleaned from the large volume of preclinical data translate into the clinical setting, these data may be valuable in the design of a Phase III program. We are keen to now obtain the full 52 week data set, and look forward to that analysis in the second half of 2014."
Study Design and Results
The objectives of the Phase II study, which is taking place at more than 90 sites throughout Europe, are to evaluate the safety, tolerability and signs of clinical effect of CCX140 in patients with diabetic nephropathy. The interim analysis through dosing of patients for 12 weeks includes measurement of CCX140 on proteinuria and hemoglobin A1c (HbA1c), which are elevated in patients with diabetic kidney disease. In the study, all patients are on standard of care, specifically, stable doses of an angiotensin-converting enzyme (ACE) or angiotensin receptor blocker (ARB), on top of which they are randomized to receive orally administered CCX140 (at a dose of either 5 mg or 10 mg), or a placebo, once daily. In the current study after two weeks of dosing the 5 mg group exhibited a 12% reduction in UACR vs. a 1% increase in the placebo (p<0.05); 10 mg exhibited an 8% reduction.
The 12 week values were -21%, -12%, -9% respectively. There were UACR drops at 12 weeks of -27% (5 mg group) and -33% (10 mg) vs. a +2% increase (placebo) in a pre-specified subset of patients that exhibited baseline UACR > 800 mg/gm; eGFR > 60 ml/min/m2. These baseline characteristics are thought to most closely represent those that can be explored in preclinical models of diabetic nephropathy. An earlier study of CCX140 has been performed in which it was dosed for 28 days in Type 2 diabetics on stable doses of metformin. In that clinical trial, patients on 10 mg once per day of CCX140 exhibited lower fasting plasma glucose levels as well as a lowering of HbA1c, relative to the background medications only (placebo) group, over the four week treatment regimen. In the present study, HbA1c levels were also statistically significantly lower in the 10 mg group vs. standard of care.
CCX140 is an inhibitor of the chemokine receptor known as CCR2 and is ChemoCentryx's lead wholly owned drug candidate. CCR2 is found on subsets of monocytes and macrophages, which are cells of the immune system believed to play an important role in inflammatory processes.
Blocking CCR2 is intended to reduce the abnormal monocyte- and macrophage-driven inflammatory response implicated in renal diseases such as diabetic nephropathy. CCR2 may also have a direct role on the function of other specialized cells in the kidney, where its inhibition would correlate with a positive therapeutic effect.
Conference Call Information
The Company will host a conference call and webcast today, September 10, at 8:00 a.m. Eastern Time to discuss interim Phase II trial results and to answer questions. To participate by telephone, please dial
877-303-8028 (Domestic) or 760-536-5167 (International). The conference ID number is 58922298.
An archived replay of this call will be accessible via the Investors section of the Company's website at www.ChemoCentryx.com. The replay will remain available for fourteen (14) days following the live call.
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.
Vercirnon (also known as Traficet-EN, CCX282 or GSK1605786), a specific
CCR9 inhibitor, is now being solely developed by GSK and is currently 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, CCX168, a C5aR inhibitor in Phase II clinical development for the treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, as well as CCX872, a
CCR2 inhibitor, and CCX507, an inhibitor of CCR9, both of which are in Phase I clinical testing. 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 and include whether the data from the Company's ongoing Phase II trial may be valuable in the design of a Phase III program, when the Company will be able to provide analysis of the full 52-week data set from the ongoing Phase II trial, and whether CCR2 inhibition could correlate with a positive therapeutic effect on other specialized cells in the kidney. 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"). 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 SEC, including ChemoCentryx's Annual Report on Form 10-K for the year ended December 31, 2012 which is 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.
Susan M. Kanaya
Senior Vice President, Finance and
Chief Financial Officer or
Markus J. Cappel, Ph.D.
Chief Business Officer
Kinkead Communications, Inc.
Posted: September 2013