-- 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 --
MOUNTAIN VIEW, Calif., Oct. 25, 2018 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq:CCXI), today announced presentations of its lead drug candidates avacopan, a complement 5a receptor inhibitor, and CCX140, an inhibitor of the chemokine receptor known as CCR2, during the American Society of Nephrology (ASN) Kidney Week 2018, the world's premier nephrology meeting, being held October 23-28 in San Diego.
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 October 25 from 10:00 a.m. to 12:00 p.m. PT, researchers will highlight the ongoing ADVOCATE Phase III pivotal trial of avacopan, ChemoCentryx’s novel, orally bioavailable, highly selective antagonist of human C5a receptor, in patients with active anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV). AAV is a potentially life-threatening systemic autoimmune disease characterized by relapses and remissions, with a presently unmet need for less toxic treatment alternatives.
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.
ChemoCentryx recently announced the completion of patient enrollment in the ADVOCATE Phase III pivotal trial with 316 patients enrolled with topline data expected in Q4 2019.
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 October 27 from 10:00 a.m. to 12:00 p.m. PT.
ChemoCentryx is currently developing its CCR2 inhibitor CCX140 in two sub-populations of primary FSGS: one in patients with nephrotic syndrome, and another in sub-nephrotic primary FSGS patients, with patient enrollment underway.
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'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 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 currently evaluating CCX140 in two sub-populations of primary FSGS: one in patients with nephrotic syndrome, and another in sub-nephrotic primary FSGS patients.
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'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.
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.
Susan M. Kanaya
Executive Vice President,
Chief Financial and Administrative Officer
Steve Klass, Burns McClellan