ChemoCentryx Announces Abstract on Avacopan in ANCA-Associated Vasculitis Selected as One of the Ten Best Abstracts at the ER...
June 08 2021 - 8:30AM
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
VasculitisThe 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.
About AvacopanAvacopan 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.
About ChemoCentryxChemoCentryx 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.
Forward-Looking StatementsChemoCentryx 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.
Contacts:Susan M. KanayaExecutive Vice
President,Chief Financial and Administrative
Officerinvestor@chemocentryx.com
Media:Stephanie
Tomei408.234.1279media@chemocentryx.com
Investors:Burns McClellan, Inc.Lee
Roth212.213.0006lroth@burnsmc.com
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