-- Rapid reduction in kidney inflammation following avacopan treatment in patients with ANCA-Associated Vasculitis revealed by analysis of markers of kidney damage --
-- Podocyte protection demonstrated with CCR2 inhibitor CCX140, supporting differentiated potential treatment option for patients with Focal Segmental Glomerulosclerosis --
"Our chemoattractant inhibitor
platform provides unique possibilities to transform the treatment of orphan kidney diseases," said Thomas
Key biomarker data show correlation with more rapid improvement of kidney inflammation following avacopan treatment in patients with ANCA-Associated Vasculitis
In a poster presentation given during ASN Kidney Week 2017 titled "Reduction in Urinary sCD163 Correlates with Clinical Benefit in the CLEAR Study of C5aR Inhibitor Avacopan in ANCA-Associated Vasculitis" researchers presented data demonstrating a much more rapid reduction of urinary sCD163/creatinine ratios occurs in patients treated with avacopan than that seen in a standard of care control group. There was a significant positive and temporal correlation of reduction in urine sCD163/creatinine ratio with another previously known biomarker of kidney inflammation, MCP-1/creatinine ratio. In patients receiving avacopan in the absence of prednisone, urine sCD163 significantly decreased within one week, whereas in patients treated with the high dose prednisone containing standard of care regimen exhibited decreases in sCD163 only much later (by week 8). These data align with other showing that treatment with avacopan leads to a more rapid improvement of kidney inflammation than seen with previous standard of care.
Study demonstrates podocyte protective properties of CCR2 inhibitor CCX140 as differentiated potential treatment option for patients with Focal Segmental Glomerulosclerosis (FSGS)
FSGS is an orphan disease of the kidney for which there is currently no approved treatment option. Like ANCA-Associated Vasculitis, FSGS causes proteinuria and leads to End Stage Renal Disease.
In an oral presentation given during ASN Kidney Week 2017 titled "CCR2 Antagonism Reduces Proteinuria and Glomerular Injury in Murine Models of Focal Segmental Glomerulosclerosis (FSGS)" researchers presented data demonstrating the efficacy of CCR2 inhibition in improving kidney function using a number in vivo pharmacological models of FSGS. Results showed a very rapid improvement in proteinuria. Moreover, the investigators demonstrated marked histological improvements in CCX140 treated animals, including increased density of podocytes, a specialized cell population in the kidney that performs key filtration functions and is known to be damaged in FSGS. The data suggest CCR2 inhibition involves a unique mechanism of action in the kidney including a novel element of renal cellular protection at the level of the podocyte.
Avacopan (CCX168) is an orally-administered small molecule that is a selective inhibitor of the complement C5a receptor, or C5aR. Avacopan is in Phase III development for the treatment of anti-neutrophil cytoplasmic auto-antibody-associated vasculitis (AAV). In clinical studies to date, avacopan was shown to be safe, well tolerated and provided effective control of the disease while also successfully allowing elimination of high-dose steroids, which are currently part of the standard of care for AAV patients. Avacopan is also being developed in patients with C3 glomerulopathy (C3G) and atypical hemolytic uremic syndrome (aHUS). In C3G, Avacopan targets the C5a receptor, blocking the effects of C5a which contributes to the inflammatory hypercellularity in the glomeruli, a main feature of C3G.
The U.S. Food and Drug Administration has granted avacopan orphan-drug designation for all three of these diseases: AAV, C3G, and aHUS. The European Commission has granted orphan medicinal product designation for avacopan for the treatment of two forms of AAV: microscopic polyangiitis and granulomatosis with polyangiitis (formerly known as Wegener's granulomatosis) and C3G.
Avacopan was also granted access to the European Medicines Agency's (EMA) PRIority MEdicines (PRIME) initiative, which supports accelerated assessment of investigational therapies addressing unmet medical need.
ChemoCentryx's orally administered small molecule CCX140 is a highly potent and selective CCR2 inhibitor with excellent preclinical and clinical profiles, including good safety and tolerability in hundreds of patients in seven clinical trials. These clinical studies include a successfully completed one-year dosing of CCX140 in a Phase II trial in chronic kidney disease associated with diabetes.
ChemoCentryx is a biopharmaceutical company developing new medications targeted at inflammatory and autoimmune diseases, and cancer. ChemoCentryx targets the chemokine and chemoattractant systems to discover, develop and commercialize orally-administered therapies. ChemoCentryx is currently focusing on its late stage drug candidates for patients with rare kidney diseases, avacopan and CCX140.
ChemoCentryx also has an immuno-oncology program, which includes a distinct CCR2 inhibitor, CCX872, currently in development for the treatment of advanced non-resectable pancreatic cancer.
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," "continue" or "project" or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. These statements include the Company's statements whether avacopan (CCX168) will be shown to be safe and effective in the treatment of ANCA-associated vasculitis and other rare diseases, whether CCX140 will be shown to be safe and effective in the treatment of focal segmental glomerulosclerosis (FSGS) and the Company's statement regarding the timing of initiating additional clinical trials to further investigate CCX140 in the treatment of FSGS. 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 14, 2017 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.
Susan M. Kanaya
Executive Vice President, Finance and Chief Financial and Administrative Officer
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