-- Rapid reduction in kidney inflammation
following avacopan treatment in patients with ANCA-Associated
Vasculitis revealed by analysis of markers of kidney damage --
ChemoCentryx, Inc., (Nasdaq:CCXI), a biopharmaceutical
company developing new medications targeted at inflammatory and
autoimmune diseases and cancer, today announced the findings of two
studies presented during the American Society of Nephrology (ASN)
Kidney Week 2017, the world’s premier nephrology meeting, being
held October 31 to November 5 in New Orleans, LA.
“Our chemoattractant inhibitor platform provides unique
possibilities to transform the treatment of orphan kidney
diseases,” said Thomas J. Schall, Ph.D., President and Chief
Executive Officer of ChemoCentryx. “Data presented during
this year’s ASN Kidney Week demonstrate that there is a marked and
rapid reduction in urine cSD163, a marker of kidney inflammation,
occurring with avacopan treatment of ANCA vasculitis patients, and
this correlates with the rapid clinical benefits seen in other
disease measurements as well. Separately, in FSGS, new science
suggests CCX140 provides protection of the kidney cells most
involved directly with the FSGS disease process itself, and these
data underpin our plans to launch a registration-supporting trial
of CCX140 in FSGS later this year.”
Key biomarker data show correlation with more rapid improvement
of kidney inflammation following avacopan treatment in patients
with ANCA-Associated Vasculitis
In a poster presentation given during ASN Kidney Week 2017
titled “Reduction in Urinary sCD163 Correlates with Clinical
Benefit in the CLEAR Study of C5aR Inhibitor Avacopan in
ANCA-Associated Vasculitis” researchers presented data
demonstrating a much more rapid reduction of urinary
sCD163/creatinine ratios occurs in patients treated with avacopan
than that seen in a standard of care control group. There was a
significant positive and temporal correlation of reduction in urine
sCD163/creatinine ratio with another previously known biomarker of
kidney inflammation, MCP-1/creatinine ratio. In patients receiving
avacopan in the absence of prednisone, urine sCD163 significantly
decreased within one week, whereas in patients treated with the
high dose prednisone containing standard of care regimen exhibited
decreases in sCD163 only much later (by week 8). These data align
with other showing that treatment with avacopan leads to a more
rapid improvement of kidney inflammation than seen with previous
standard of care.
Study demonstrates podocyte protective properties of CCR2
inhibitor CCX140 as differentiated potential treatment option for
patients with Focal Segmental Glomerulosclerosis (FSGS)
FSGS is an orphan disease of the kidney for which there is
currently no approved treatment option. Like ANCA-Associated
Vasculitis, FSGS causes proteinuria and leads to End Stage Renal
Disease.
In an oral presentation given during ASN Kidney Week 2017 titled
“CCR2 Antagonism Reduces Proteinuria and Glomerular Injury in
Murine Models of Focal Segmental Glomerulosclerosis (FSGS)”
researchers presented data demonstrating the efficacy of CCR2
inhibition in improving kidney function using a number in vivo
pharmacological models of FSGS. Results showed a very rapid
improvement in proteinuria. Moreover, the investigators
demonstrated marked histological improvements in CCX140 treated
animals, including increased density of podocytes, a specialized
cell population in the kidney that performs key filtration
functions and is known to be damaged in FSGS. The data suggest CCR2
inhibition involves a unique mechanism of action in the kidney
including a novel element of renal cellular protection at the level
of the podocyte.
About Avacopan
Avacopan (CCX168) is an orally-administered small molecule that
is a selective inhibitor of the complement C5a receptor, or
C5aR. Avacopan is in Phase III development for the treatment
of anti-neutrophil cytoplasmic auto-antibody-associated vasculitis
(AAV). In clinical studies to date, avacopan was shown to be safe,
well tolerated and provided effective control of the disease while
also successfully allowing elimination of high-dose steroids, which
are currently part of the standard of care for AAV patients.
Avacopan is also being developed in patients with C3 glomerulopathy
(C3G) and atypical hemolytic uremic syndrome (aHUS). In C3G,
Avacopan targets the C5a receptor, blocking the effects of C5a
which contributes to the inflammatory hypercellularity in the
glomeruli, a main feature of C3G.
The U.S. Food and Drug Administration has granted
avacopan orphan-drug designation for all three of these diseases:
AAV, C3G, and aHUS. The European Commission has granted
orphan medicinal product designation for avacopan for the treatment
of two forms of AAV: microscopic polyangiitis and granulomatosis
with polyangiitis (formerly known as Wegener's granulomatosis) and
C3G.
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 CCX140
ChemoCentryx’s orally administered small molecule CCX140 is a
highly potent and selective CCR2 inhibitor with excellent
preclinical and clinical profiles, including good safety and
tolerability in hundreds of patients in seven clinical trials.
These clinical studies include a successfully completed one-year
dosing of CCX140 in a Phase II trial in chronic kidney disease
associated with diabetes. ChemoCentryx plans to launch it its late
stage development program of CCX140 in patients with FSGS by the
end of 2017.
About ChemoCentryx
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 is currently
focusing on its late stage drug candidates for patients with rare
kidney diseases, avacopan and CCX140.
ChemoCentryx's Kidney Health Alliance with Vifor
Pharma provides Vifor Pharma with exclusive rights
to commercialize Avacopan and CCX140 in markets outside of
the U.S. and China.
ChemoCentryx also has an immuno-oncology program, which
includes a distinct CCR2 inhibitor, CCX872, currently in
development for the treatment of advanced non-resectable pancreatic
cancer.
Forward-Looking Statements
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 whether avacopan (CCX168) will be shown to be safe and
effective in the treatment of ANCA-associated vasculitis and other
rare diseases, whether CCX140 will be shown to be safe and
effective in the treatment of focal segmental glomerulosclerosis
(FSGS) and the Company's statement regarding the timing of
initiating additional clinical trials to further investigate CCX140
in the treatment of FSGS. 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, 2017 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, Inc.CCXI-G
Contacts:
Susan M.
Kanaya
Executive Vice President, Finance and Chief Financial and
Administrative
Officer
investor@chemocentryx.com
Media:Stephanie Tomei408.234.1279tomei.stephanie@gmail.com
Investors:Burns McClellan, Inc. Steve
Klass212.213.0006
sklass@burnsmc.com
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