Presentations at ASN Kidney Week 2018 Highlight ChemoCentryx Platform in Treatment of ANCA-Associated Vasculitis and Focal Segmental Glomerulosclerosis (FSGS)
-- Highlights Study Design, Outcome Measures, and Baseline Patient Data in the Ongoing Avacopan ADVOCATE Phase III Pivotal Trial in ANCA-Associated Vasculitis --
-- Reveals Potential New Role for Chemokine Receptor 2 (CCR2) in the Treatment of Focal Segmental Glomerulosclerosis (FSGS) with First Demonstration of CCR2 Presence on Renal Progenitor Cells Destined to Become Podocytes --
ADVOCATE: A randomized phase 3 trial evaluating the safety and efficacy of avacopan in patients with new diagnosed or relapsing anti-neutrophil cytoplasmic antibody-associated vasculitis
In an informational poster session on
Primary endpoints of the Phase III ADVOCATE trial are proportion of patients in remission at week 26 based on a Birmingham Vasculitis Activity Score (BVAS) of zero and not taking glucocorticoid steroids (GCS) within 4 weeks prior to week 26 and proportion of patients who sustain remission from week 26 through week 52 and not taking GCS within 4 weeks prior to week 52. Quality of life will also be assessed over the 52 weeks. Other endpoints include adverse events, requirement for rescue medications, renal disease markers, GCS Toxicity Index, and Vasculitis Damage Index.
Expression of Chemokine Receptor 2 (CCR2) on Renal Podocyte Progenitor Cells
Recent studies have shown that inhibition of chemokine receptor 2 (CCR2) by small molecule inhibitors markedly reduce proteinuria, improve renal function and preserve or restore podocyte density in in vivo models of Focal Segmental Glomerulosclerosis (FSGS), an orphan disease of the kidney for which there is currently no approved treatment option.
To understand the mechanism of this protection, the study examined the expression of CCR2 on human and murine kidneys and found clear evidence that CCR2 is present on non-hematopoietic cells in the kidney. This finding includes the first demonstration of the presence of CCR2 on renal progenitor cells that are destined to become podocytes, and reveals a potential new role for CCR2 in the treatment of FSGS, and possibly other renal diseases.
Researchers will present these findings as part of the Glomerular Diseases: Immunology and Inflammation III session on
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 hidradenitis suppurativa (HS).
The U.S. Food and Drug Administration has granted avacopan orphan-drug designation for all AAV, C3G, and atypical hemolytic uremic syndrome. 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 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 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-associated 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. ChemoCentryx is also developing avacopan for the treatment of patients with C3 glomerulopathy (C3G) and hidradenitis suppurativa (HS). The U.S. Food and Drug Administration has granted avacopan orphan-drug designation for ANCA-associated Vasculitis, C3G and atypical hemolytic uremic syndrome (aHUS). The European Commission has granted orphan medicinal product designation for avacopan for the treatment of two forms of ANCA-associated 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. The U.S. Food and Drug Administration has granted CCX140 orphan-drug designation for the treatment of FSGS.
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 the achievement of anticipated goals and milestones, whether avacopan will be effective in the treatment of AAV, whether CCR2 inhibition and its potential role on renal progenitor cells destined to become podocytes will be an effective treatment of FSGS, and whether the Company's drug candidates will be shown to be effective in ongoing or future clinical trials. 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.
Executive Vice President,
Chief Financial and Administrative Officer
Source: ChemoCentryx, Inc.