ChemoCentryx Phase III ADVOCATE Trial of Avacopan in ANCA-Associated Vasculitis Highlighted in Oral Plenary Presentations at EULAR and ERA-EDTA Congresses
Pivotal trial demonstrated avacopan’s statistical superiority in sustaining remission at 52 weeks over the glucocorticoid-containing standard-of-care therapy
MOUNTAIN VIEW, Calif., June 03, 2020 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (NASDAQ: CCXI) today announced presentations highlighting outcomes of the Company’s Phase III ADVOCATE trial as part of the virtual annual meetings of the leading European rheumatology and nephrology organizations, EULAR (European League Against Rheumatism) and ERA-EDTA (European Renal Association - European Dialysis and Transplant Association), being held June 3-6 and June 6-9, respectively.
EULAR – Open Plenary Abstract Session
Title: A Randomized, Double-Blind, Active-Controlled Study of Avacopan in Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis
Date: Wednesday, June 3, 2020
Time: 15:10-15:20 CEST (9:10-9:20 a.m. ET)
Presenter: Dr. Peter Merkel
ERA-EDTA – Oral Presentation, Plenary
Title: A Randomized, Double-Blind, Active Controlled Study of Avacopan in Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Date: Sunday, June 7, 2020
Time: 12:15-12:25 CEST (6:15-6:25 a.m. ET)
Presenter: Dr. David Jayne
About ADVOCATE and ANCA Vasculitis
The ADVOCATE trial of avacopan was a global randomized, double-blind, active-controlled, double-dummied Phase III trial of 331 patients with ANCA-associated vasculitis in 20 countries. Eligible study subjects were randomized to receive avacopan plus either rituximab or cyclophosphamide (followed by azathioprine/mycophenolate) or prednisone plus either rituximab or cyclophosphamide (followed by azathioprine/mycophenolate). The treatment period was 52 weeks.
ANCA vasculitis is a systemic disease in which over-activation of the complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels. This results in organ damage and failure, with the kidney as the major target, and is fatal if not treated. Currently treatment for ANCA vasculitis consists of courses of non-specific immuno-suppressants (cyclophosphamide or rituximab), combined with high-dose corticosteroid administration for prolonged periods of time, which can be associated with significant clinical risk including death from infection.
Avacopan is a first-in-class, orally-administered molecule that employs a novel, highly targeted mode of action in the treatment of ANCA-associated vasculitis and other complement-driven autoimmune and inflammatory diseases. By precisely blocking the receptor (the C5aR) for the pro-inflammatory complement system fragment known as C5a on destructive inflammatory cells such as blood neutrophils, avacopan arrests the ability of those cells to do damage in response to C5a activation, which is known to be the driver of ANCA-associated vasculitis. Current therapies for ANCA vasculitis and other related illnesses typically include broad immunosuppression with high doses of glucocorticoids (steroids) such as prednisone or methylprednisone, which cause significant illness and even death. Avacopan therapy was designed to prevent these outcomes. Moreover, avacopan’s selective inhibition of only the C5aR leaves the beneficial C5a pathway through the C5L2 receptor functioning normally.
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 and C3G. 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.
ChemoCentryx's Kidney Health Alliance with Vifor Pharma provides Vifor Pharma with exclusive rights to commercialize avacopan in markets outside of the U.S.
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’s lead drug candidate, avacopan (CCX168), recently completed a pivotal Phase III trial in ANCA-associated vasculitis.
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 the avacopan NDA for ANCA vasculitis will be filed mid-year, whether avacopan will be approved for the treatment of ANCA vasculitis, the timing of topline data from the avacopan Phase II studies in the treatment of HS and C3G 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 10, 2020 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
William Slattery, Jr., Burns McClellan