-- Abstract on ‘The Effect of Avacopan, a Complement C5a Receptor Inhibitor, on Kidney Function in Patients with ANCA-Associated Vasculitis with Renal Disease’ honored on “Ten Best” list by the Paper Selection Committee of ERA-EDTA --
-- Abstract on the Phase II ACCOLADE Study of Avacopan for the Treatment of C3G Glomerulopathy accepted by ERA-EULAR in Late Breaking Clinical Trials Session --
SAN CARLOS, Calif., June 08, 2021 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq: CCXI), today announced presentations highlighting outcomes of the Company’s Phase III ADVOCATE trial and Phase II ACCOLADE and LUMINA-1 trials as part of the annual meeting of the ERA-EDTA (European Renal Association – European Dialysis and Transplant Association), held in Berlin, Germany and virtually June 5-8, 2021.
The Paper Selection Committee of ERA-EDTA chose Dr. David Jayne’s presentation ‘The Effect of Avacopan, a Complement C5a Receptor Inhibitor, on Kidney Function in Patients with ANCA-Associated Vasculitis with Renal Disease’ as one of the ten best abstracts of the entire Congress. In his presentation, Dr. Jayne showed data from the Phase III ADVOCATE trial that treatment with avacopan in patients with ANCA vasculitis with renal disease led to greater recovery in estimated Glomerular Filtration Rate (eGFR), a key measure of kidney function and a more rapid improvement in the urine albumin-to-creatinine ratio than prednisone, with the potential to reduce longer term risks of end stage renal failure and death.
Avacopan was also featured in a late-breaking clinical trial presentation: ‘Orally Administered C5aR Inhibitor Avacopan in a Randomized, Double Blind, Placebo-Controlled Study for Treatment of C3G Glomerulopathy’. Dr. Andrew Bomback noted that although the number of patients in the study are too small to permit definitive conclusions, the ACCOLADE study is the largest trial yet of patients with this rare kidney disease, for which there are no approved treatments. He reported that the data suggested evidence of effect with avacopan, with a mean improvement in the disease activity score and significant improvements in the disease chronicity score and eGFR, compared to the placebo group at 26 weeks.
A third abstract featured at ERA-EDTA was ‘A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study (LUMINA-1) to Evaluate the Safety and Efficacy of CCX140 in Subjects with Focal Segmental Glomerulosclerosis (FSGS)’, presented by Dr. Frank Cortazar. ChemoCentryx does not plan to pursue further development of CCX140 in FSGS.
About ADVOCATE and ANCA-Associated Vasculitis
The ADVOCATE trial of avacopan was a global, randomized, double-blind, active-controlled, double-dummy 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).
ANCA-associated 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-associated vasculitis consists of courses of non-specific immuno-suppressants (cyclophosphamide or rituximab), combined with the administration of daily glucocorticoids (steroids) 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 small 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-associated vasculitis and other related illnesses typically include broad immunosuppression with daily doses of glucocorticoids (steroids) such as prednisone or methylprednisone, which can cause significant illness and even death. 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 is responsible for the discovery and development of avacopan and owns and retains the commercial rights to the drug in the United States. 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 for 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), successfully completed a pivotal Phase III trial in ANCA-associated vasculitis and a New Drug Application is under review by the U.S. Food and Drug Administration. Avacopan is also in late stage clinical development for the treatment of severe Hidradenitis Suppurativa and C3 glomerulopathy (C3G).
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 timing of anticipated PDUFA date for the avacopan NDA for the treatment of ANCA-associated vasculitis, the achievement of anticipated goals and milestones, whether avacopan will be approved by the FDA for the treatment of ANCA-associated vasculitis, whether avacopan will be an effective treatment in other indications such as 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 11, 2021 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
Burns McClellan, Inc.
Source: ChemoCentryx, Inc.