-- Oral presentation at the American Society of
Nephrology (ASN) Kidney Week 2016 to highlight Phase II AAV CLEAR
trial results --
ChemoCentryx, Inc., (Nasdaq:CCXI), today announced oral
presentations at two upcoming medical meetings discussing the
positive results obtained from the Phase II CLEAR and CLASSIC
trials of CCX168 (newly designated ‘avacopan’) in patients with
anti-neutrophil cytoplasmic auto-antibody (ANCA) -associated
vasculitis (AAV). Avacopan is a potent orally-administered small
molecule that is a selective inhibitor of the complement C5a
receptor, or C5aR, and is the lead drug candidate in the Company's
orphan and rare disease program.
The current standard of care in AAV uses high doses of chronic
glucocorticoids (steroids such as prednisone or prednisolone),
which can cause significant safety issues, including premature
death. The Phase II CLEAR trial was designed to assess whether
avacopan could provide highly effective control of AAV disease
while also eliminating the need for steroids. Separately, the Phase
II study known as CLASSIC was designed primarily as a safety study
to inform eventual labeling requirements for avacopan. As
previously reported, the CLEAR and CLASSIC trials both successfully
met their objectives.
“The positive results from the CLEAR and CLASSIC trials mark the
successful culmination of our Phase II development program with
avacopan in AAV. We believe the data show strongly that avacopan,
via a novel mechanism for the treatment of AAV, provides rapid and
effective control of the disease. Importantly, the data also
show that avacopan eliminates the need for chronic high doses of
steroids currently used in the standard of care,” said Thomas J.
Schall, Ph.D., President and Chief Executive Officer of
ChemoCentryx. “It follows that the robust datasets to be presented
at these two upcoming medical meetings support our advancing
avacopan into Phase III development, which we are now preparing to
do.”
Presentation information is as follows:
AAV
Phase II CLEAR Oral Presentation: |
|
|
Conference: |
American
Society of Nephrology (ASN) Kidney Week 2016 |
Title: |
Rapid Onset
of Action of Orally Administered C5aR Inhibitor CCX168 in
Randomized Clinical Trial in ANCA-Associated Vasculitis
(CLEAR) |
Presenter: |
Prof.
Vladimír Tesař, MD, PhD, MBA, FASN, Department of Nephrology,
Charles University and Principal Investigator of the CLEAR
trial |
Session: |
CKD and AKI
Clinical Trials |
Date & Time: |
Thursday,
11/17/2016, Presentation Start Time: 5:42 PM. CT |
Location: |
Session room
S103, McCormick Place, Chicago, IL. |
|
|
AAV Phase II CLASSIC Oral
Presentation: |
|
|
Conference: |
American
College of Rheumatology (ACR) 2016 Annual Meeting |
Title: |
A Randomized
Clinical Trial of CCX168, an Orally Administered C5aR Inhibitor for
Treatment of Patients with ANCA-Associated Vasculitis |
Presenter: |
Dr. Peter A.
Merkel, Chief of Rheumatology and Professor of Medicine at the
University of Pennsylvania |
Session: |
Vasculitis
I: Novel Approaches to Therapy |
Date & Time: |
Sunday,
November 13, 2016, 3:15 PM - 3:30 PM CT |
Location: |
Walter E.
Washington Convention Center, Washington, D.C. |
About CCX168 (avacopan)
CCX168 (avacopan) is an orally-administered small molecule that
is a selective inhibitor of the complement C5a receptor, or C5aR,
and is the lead drug candidate in the Company's orphan and rare
disease program. The U.S. Food and Drug Administration
granted orphan-drug designation for avacopan for the treatment of
patients with AAV, (which includes Wegener's granulomatosis,
microscopic polyangiitis, and Churg-Strauss syndrome) and also for
the treatment of patients with atypical hemolytic uremic syndrome
(aHUS). The European Commission has granted orphan medicinal
product designation for avacopan for the treatment of microscopic
polyangiitis and granulomatosis with polyangiitis (formerly known
as Wegener’s granulomatosis). Both conditions are forms of AAV.
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.
About ANCA-Associated Vasculitis
Anti-neutrophil cytoplasmic auto-antibody (ANCA)-associated
vasculitis, or AAV, is a type of rare autoimmune inflammation
caused by auto-antibodies. AAV encompasses granulomatosis with
polyangiitis (GPA, formerly known as Wegener's granulomatosis),
microscopic polyangiitis (MPA), eosinophilic polyangiitis (formerly
Churg-Strauss syndrome) and renal limited vasculitis.
AAV represents a severe and often fatal autoimmune disease that
is characterized by inflammation that can destroy different organ
systems. AAV is the lead indication in the Company's orphan and
rare disease program which has the objective of eliminating chronic
high dose steroids, which are associated with significant safety
issues including death, from the standard of care (SOC) regimen in
AAV and replace steroids with avacopan.
AAV affects approximately 40,000 people in the U.S. (with
approximately 4,000 new cases each year) and greater than 75,000
people in Europe (with at least 7,500 new cases each year), and is
currently treated with courses of immuno-suppressants
(cyclophosphamide or rituximab) combined with high dose steroid
administration. Following initial treatment, up to 30 percent of
patients relapse within six to 18 months, and approximately half of
all patients will relapse within three to five years.
Current SOC for AAV is associated with significant safety
issues. First year mortality is approximately 11 to 18 percent. The
single major cause of premature mortality is not disease-related
adverse events, but rather infection that is thought largely to be
a consequence of steroid administration. Indeed, the multiple
adverse effects of courses of steroid treatment (both initial
courses and those that are repeated as a consequence of relapse)
are major causes of both short-term and long-term disease and
death. Such therapy related adverse events contribute significantly
to patient care costs, as well as to the diminution of quality of
life for patients.
By damaging the body's small blood vessels, AAV affects many
organ systems, mostly the kidneys, eyes, lungs, sinuses and nerves.
This damage is caused by the destructive activity of inflammatory
leukocytes in the body, with neutrophils considered to be the
terminal effector cell. In AAV, neutrophils are attracted to sites
of vascular destruction as well as activated at those sites by the
activity of the complement system product known as C5a and its
receptor, C5aR, which is the target of avacopan. By blocking
the C5aR, avacopan is thought to reduce vasculitis by reducing
neutrophil activation, accumulation, and adhesion, as well as
vascular permeability.
About ChemoCentryxChemoCentryx, Inc. is a
clinical-stage biopharmaceutical company focused on discovering,
developing and commercializing orally-administered therapeutics
that target the chemokine and chemoattractant systems in order to
treat autoimmune diseases, inflammatory disorders and cancer. The
chemokine system is a biological network that regulates
inflammation via a collection of secreted chemokine molecules, or
ligands, and their specific cell surface receptors. Based on its
proprietary drug discovery and drug development platform,
ChemoCentryx has generated multiple clinical and preclinical-stage
programs, each targeting distinct chemokine and chemoattractant
receptors with different small molecule compounds. Avacopan, a C5aR
inhibitor, is in Phase II development for the treatment of
anti-neutrophil cytoplasmic auto- antibody associated vasculitis
(AAV). Avacopan appears to be safe, well tolerated and successful
in allowing reduction and elimination of high-dose steroids, part
of standard of care for AAV patients, while providing effective
control of the disease in clinical studies to date. Avacopan is
also in Phase II studies for the treatment of atypical hemolytic
uremic syndrome (aHUS) and immunoglobulin A nephropathy, or IgA
nephropathy (IgAN). ChemoCentryx has licensed exclusive rights to
Vifor Pharma to commercialize Avacopan in Europe and certain other
markets outside of the U.S. and most of Asia. CCX872, a CCR2
inhibitor, successfully completed Phase I development and is in
development for the treatment of non-resectable pancreatic cancer.
CCX140, a distinct CCR2 inhibitor, successfully completed a Phase
II clinical trial where it was shown to be safe and well tolerated
while demonstrating statistically significant improvement in
albuminuria in patients with diabetic nephropathy. Other clinical
programs include CCX507, a next generation CCR9 inhibitor, which
has successfully completed Phase I development, vercirnon (also
known as Traficet-EN or CCX282) a specific CCR9 inhibitor for the
treatment of inflammatory bowel disease, and CCX354, a CCR1
inhibitor which successfully completed a Phase II clinical trial
for the treatment of rheumatoid arthritis. ChemoCentryx also has
several programs in advanced preclinical development.
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 timing of initiating
Phase III development in AAV for avacopan and whether avacopan will
be shown to be effective in Phase III clinical trials in the
treatment of AAV and other orphan and rare diseases. 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 March 14, 2016 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.
Source: ChemoCentryx (CCXI-G)
Contacts:
Susan M. Kanaya
Executive Vice President, Chief Financial and Administrative Officer
investor@chemocentryx.com
Media:
Denise Powell
denise@redhousecomms.com
510.703.9491
Investors:
Steve Klass
Burns McClellan
212.213.0006
sklass@burnsmc.com
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