Phase II diabetic nephropathy trial results showing improvements in proteinuria over 52 weeks of treatment, sustained effect in follow-up period after drug withdrawal; potential renoprotective, disease modifying effect of CCR2 inhibitor CCX140 highlighted in oral presentation
Dose-dependent anti-thrombogenic effect also shown with complement system inhibition by CCX168 in atypical hemolytic uremic syndrome patients' sera
MOUNTAIN VIEW, Calif., Nov. 5, 2015 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq: CCXI ), a clinical-stage biopharmaceutical company focused on autoimmune diseases, inflammatory disorders and cancer, today announced data presentations from two of its chemoattractant receptor programs at the American Society of Nephrology Kidney Week Annual Meeting being held November 5 to 8 in San Diego, California.
Efficacy in Diabetic Nephropathy in a Phase II Clinical Trial of Chemokine Receptor 2 Inhibitor CCX140-B, Glassock et al, (Abstract #TH-OR031, oral presentation, November 5, 4:30 p.m. PT, Session: Clinical Trials in CKD: Pursuing a New Horizon, Room 25)
Professor Richard Glassock will present data from the Company's Phase II clinical trial in patients with diabetic nephropathy with CCX140, a selective inhibitor of the chemokine receptor known as CCR2. As previously reported, the trial successfully met its primary endpoint by showing that CCX140 improves albuminuria beyond that seen with standard of care therapies alone, i.e., blockers of the angiotensin pathway (ACE or ARB inhibitor treatment).
Dr. Glassock's presentation includes a description and analysis of the statistically significant improvement in levels of protein in the urine (measured as Urinary Albumin Creatinine Ratio, or UACR) across the entire Phase II patient population tested, and particularly the marked improvements in the pre-specified patient group who had the highest proteinuria when enrolled in the study (patients who comprised approximately one-third of the Phase II study population). CCX140 appeared to be well tolerated, with a low overall dropout rate over the 52-week treatment period. Also, 4 week post-treatment follow-up data indicate a persistence of therapeutic effect after CCX140 was withdrawn, consistent with disease modifying properties of the drug in diabetic nephropathy.
"The current standards of care in the treatment of chronic kidney disease unfortunately only slow disease progression and, for patients and their families, end stage renal disease is devastating," said Professor Richard Glassock, M.D., David Geffen School of Medicine at UCLA. "It is particularly encouraging to see the sustained effect CCX140 has on UACR during treatment as well as after discontinuation of treatment, indicating CCX140 may have a disease modifying effect. Taken together, these results position CCX140 as a promising potential new treatment for patients with diabetic nephropathy."
Orally Administered Complement 5a Receptor Inhibitor CCX168 Development in Atypical Hemolytic Uremic Syndrome, Galbusera et al, (Abstract #FR PO169, poster presentation November 6 from 10:00 a.m.-12:00 p.m. PT, Session: Mendelian Disease of the Kidney, Halls A-B)
Dr. Miriam Galbusera, renal disease investigator in Professor Giuseppe Remuzzi's team at the Mario Negri Institute in Bergamo, Italy will present results from an ex vivo study evaluating the effect of CCX168 on the prothrombogenic activity induced by serum from patients with atypical hemolytic uremic syndrome, or aHUS, on vascular endothelial cells. The effect of CCX168 was compared with eculizumab (also known as Soliris), which was used as a comparator approved for clinical use. CCX168 inhibited thrombus formation in a concentration-dependent manner. Importantly, the effect of CCX168 was similar to that of eculizumab, which is being used for treatment of patients with aHUS. In a currently ongoing ChemoCentryx Phase II proof-of-concept clinical trial, patients with aHUS and end stage renal disease are receiving twice daily doses of 30 mg CCX168 for 15 days.
"Patients with aHUS are at risk for life-threatening complications such as renal failure," said Giuseppe Remuzzi, M.D., Professor of Nephrology and Director of the Department of Immunology and Clinical Transplantation of the Ospedali Riuniti di Bergamo, Italy and Director of the Division of Nephrology and Dialysis of the same hospital. "The inhibition by CCX168 of thrombus formation induced by aHUS serum in this side-by-side comparison of CCX168 and eculizumab is encouraging. We are excited to be conducting a clinical trial with the hope that CCX168 will become a potential treatment option for patients with this devastating condition."
About CCX140 CCX140 targets the chemokine receptor known as CCR2 and is being developed as an orally administered therapy for the treatment of diabetic nephropathy, or diabetic kidney disease. CCX140 is the lead drug candidate in the Company's chronic kidney disease program. 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 in the function of other specialized cells in the kidney, where its inhibition would correlate with a positive therapeutic effect.
CCX140 has successfully completed a Phase II clinical trial in patients with diabetic nephropathy where it was shown to be safe and well tolerated while demonstrating statistically significant improvements in kidney function.
About CCX168 CCX168, a C5aR inhibitor, targets the chemoattractant receptor known as C5aR (which binds to the complement fragment C5a). CCX168 is the lead drug candidate in the Company's orphan and rare disease program. ChemoCentryx is developing CCX168 for various autoimmune disorders including anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV), atypical hemolytic uremic syndrome (aHUS) and immunoglobulin A nephropathy (IgAN).
In patients with 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, without compromising efficacy or safety during a 12-week treatment period in the first two steps of a Phase II clinical trial.
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, successfully completed a Phase II clinical trial where it was shown to be safe and well tolerated while demonstrating statistically significant improvements in kidney function in patients with 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. CCX168 is also in Phase II pilot studies for the treatment of atypical Hemolytic Uremic Syndrome (aHUS) and Immunoglobulin A nephropathy, or IgA nephropathy (IgAN). CCX872, a second CCR2 inhibitor, successfully completed Phase I development and is in development for the treatment of non-resectable pancreatic cancer. Vercirnon (also known as Traficet-EN or CCX282) is a specific CCR9 inhibitor for the treatment of inflammatory bowel disease. Other clinical programs include 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. These statements include statements regarding the potential of CCX140 to be an effective treatment of diabetic nephropathy or whether CCX168 will be effective in the treatment of atypical hemolytic uremic syndrome. 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 Annual Report on Form 10-K filed with the SEC March 13, 2015 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 Section 21E of the Private Securities Litigation Reform Act of 1995.
Source: ChemoCentryx (CCXI-G)
Susan M. Kanaya Senior Vice President, Finance and Chief Financial Officer or Markus J. Cappel, Ph.D. Chief Business Officer 650.210.2900 Media: Denise Powell 510.703.9491 Investors: Kimberly Minarovich Burns McClellan 212.213.0006
