— Peer-reviewed findings show blocking CCR2 provides rapid and sustained renal benefit in well-established models of FSGS —
— Improvements in renal function with CCR2 inhibition associated with encouraging histological changes, including increased podocyte density —
MOUNTAIN VIEW, Calif., March 22, 2018 (GLOBE NEWSWIRE) — ChemoCentryx, Inc., (Nasdaq:CCXI), announced today the peer-reviewed publication of positive results from in vivo studies examining the efficacy of inhibiting the chemokine receptor known as CCR2 in the treatment of focal segmental glomerulosclerosis (FSGS), a debilitating chronic kidney disorder with no approved treatment option. Data presented in the publication show that blocking CCR2 provides rapid and sustained renal protection in two well-established models of FSGS, as measured by reduction in proteinuria and improvement in multiple histological parameters. The findings were published in the journal PLOS ONE under the title “CCR2 antagonism leads to marked reduction in proteinuria and glomerular injury in murine models of focal segmental glomerulosclerosis (FSGS).”
“This emerging new science revealing a novel role of CCR2 in the glomerulus of FSGS models is yet another example of cutting-edge discovery here at ChemoCentryx,” said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. “The rapid and sustained reduction in proteinuria and improved histological changes, including increased podocyte density, demonstrated with CCR2 inhibition in our models, support our strategy of conducting two clinical studies with the CCR2 inhibitor CCX140 in non-nephrotic primary FSGS patients, as well as in primary FSGS patients with nephrotic syndrome where reduction in proteinuria may constitute a provisional registration endpoint.”
Key findings from the study include:
- In two murine FSGS models, CCR2 inhibition markedly reduced proteinuria and improved renal function, both as a single agent and in combination with renin-angiotensin-aldosterone system (RAAS) blockade;
- The combination of CCR2 inhibition and RAAS blockade was as effective as the combination of endothelin receptor inhibition and RAAS blockade; and
- Improvements in renal function observed with CCR2 inhibition were associated with encouraging histological changes, as assessed by decreased glomerular sclerosis, mesangial expansion and tubular collapse, including increased podocyte density.
The article citation is: Zhenhua Miao, Linda S. Ertl, Dale Newland, Bin Zhao, Yu Wang, James J. Campbell, Xiaoli Liu, Ton Dang, Shichang Miao, Jeffrey McMahon, Penglie Zhang, Israel F. Charo, Thomas J. Schall, Rajinder Singh. (2018) CCR2 antagonism leads to marked reduction in proteinuria and glomerular injury in murine models of focal segmental glomerulosclerosis (FSGS). PLoS ONE 13(3): e0192405. https://doi.org/10.1371/journal.pone.0192405
Focal segmental glomerulosclerosis (FSGS) is an orphan disease of the kidney’s filtering units (glomeruli), and is characterized by serious scarring that leads to permanent kidney damage. FSGS presents with proteinuria, in which protein is found in the urine due to a breakdown of the normal filtration mechanism in the kidney. With more than 5,400 new cases every year in the U.S., FSGS is one of the causes of a serious condition known as Nephrotic Syndrome and often leads to end-stage renal disease (ESRD). There is no approved treatment option for FSGS patients.
ChemoCentryx’s orally administered small molecule CCX140 is a highly potent and selective inhibitor of the chemokine receptor known as CCR2 with excellent preclinical and clinical profiles, including good safety and tolerability demonstrated in hundreds of patients across 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, which demonstrated a statistically significant reduction in proteinuria compared to standard of care, with the most pronounced effect shown in the highest proteinuric patients. Preclinical data to date suggests 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 leading to rapid improvement in proteinuria. Building upon its orphan kidney disease franchise, ChemoCentryx has launched it its late stage development program of CCX140 in patients with FSGS.
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 (CCX168) and CCX140.
Avacopan 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 (ANCA Vasculitis). In clinical studies to date, avacopan was shown to be safe, well tolerated and provided effective control of the disease while allowing elimination of high-dose steroids, part of the current standard of care. Avacopan is also being developed in patients with C3 glomerulopathy (C3G), hidradenitis suppurativa (HS) and atypical hemolytic uremic syndrome (aHUS). The U.S. Food and Drug Administration has granted avacopan orphan-drug designation for ANCA Vasculitis, C3G and aHUS. The European Commission has granted orphan medicinal product designation for avacopan for the treatment of two forms of ANCA Vasculitis: microscopic polyangiitis and granulomatosis with polyangiitis (formerly known as Wegener’s granulomatosis), as well as for 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.
The Company’s other late stage drug candidate is CCX140, an inhibitor of the chemokine receptor known as CCR2, which is currently being developed for patients with focal segmental glomerulosclerosis (FSGS), a debilitating kidney disease.
ChemoCentryx’s Kidney Health Alliance with Vifor Pharma provides Vifor Pharma with exclusive rights to commercialize avacopan and CCX140 in markets outside of the U.S. and China.
ChemoCentryx also has early stage drug candidates that target chemoattractant receptors in other Inflammatory and autoimmune diseases and in 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 regarding whether inhibiting the chemokine receptor known as CCR2 will be effective in the treatment of focal segmental glomerulosclerosis (FSGS) and whether a reduction in proteinuria in primary FSGS patients with nephrotic syndrome will constitute a provisional registration endpoint. 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 on March 12, 2018 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, Inc.
Susan M. Kanaya
Executive Vice President, Chief Financial and Administrative Officer
Burns McClellan, Inc.