ChemoCentryx Announces Plenary Session at ACR Convergence 2020 to Highlight Findings of ADVOCATE Phase III Trial in ANCA-Asso...
November 06 2020 - 8:30AM
ChemoCentryx, Inc., (Nasdaq: CCXI), today announced that ACR
Convergence 2020 -- the virtual annual meeting of the American
College of Rheumatology -- will feature a plenary session
presentation today on the ADVOCATE Phase III trial results of the
Company’s lead drug candidate avacopan, an orally administered
complement 5a receptor inhibitor, in the treatment of
ANCA-associated vasculitis. A New Drug Application (NDA) for
avacopan in ANCA-associated vasculitis is under review by the U.S.
Food and Drug Administration.
The Effect on Renal Function of the
Complement C5a Receptor Inhibitor Avacopan
inANCA-Associated Vasculitis
- Today, Friday, November 6, 2020 (Abstract: 0432) as part of
Plenary Session I (0429–0433) from 11:30 a.m. to 1:00 p.m. ET
- Presented by Peter Merkel, M.D., MPH, from the Hospital of the
University of Pennsylvania
The presentation will highlight the results from the randomized,
double-blind Phase III ADVOCATE trial, which compared treatment
with avacopan head-to-head with standard daily glucocorticoid
(prednisone) therapy. The study showed that avacopan was as
effective as prednisone therapy in bringing patients into remission
by 26 weeks, and superior to prednisone for sustained remission
after 52 weeks. In addition, the avacopan group had greater
improvement in renal function compared to standard prednisone
therapy.
As noted in the authors’ conclusion, “These findings suggest the
potential for better long-term outcomes with avacopan for patients
with renal disease than current standard of care treatment and
provide intriguing insights into subclinical renal disease activity
in ANCA-associated vasculitis.”
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 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.
The U.S. Food and Drug Administration (FDA) is evaluating a New
Drug Application (NDA) for avacopan for the treatment of
ANCA-associated vasculitis and has set a Prescription Drug User Fee
Act (PDUFA) goal date of July 7, 2021.
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.
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
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 or HS,
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.
Contacts:Susan M. KanayaExecutive Vice
President,Chief Financial and Administrative
Officerinvestor@chemocentryx.com
Media:Stephanie
Tomei408.234.1279media@chemocentryx.com
Investors:Burns McClellan, Inc. Steve
Klass212.213.0006 sklass@burnsmc.com
ChemoCentryx (NASDAQ:CCXI)
Historical Stock Chart
From Mar 2024 to Apr 2024
ChemoCentryx (NASDAQ:CCXI)
Historical Stock Chart
From Apr 2023 to Apr 2024