-- Clinical Study Shows Drop in Proteinuria in
Patients Treated with Avacopan for IgA Nephropathy (IgAN) --
ChemoCentryx, Inc., (Nasdaq:CCXI), a biopharmaceutical company
developing new medications targeted at inflammatory and autoimmune
diseases and cancer, announced today the findings of two studies
presented during the 54th European Renal
Association - European Dialysis and Transplant
Association (ERA-EDTA) Congress held June 3-6 in Madrid, Spain.
“The findings presented at ERA-EDTA illustrate the value of our
chemoattractant inhibitor platform in the treatment of kidney
disease,” said Thomas J. Schall, Ph.D., President and Chief
Executive Officer of ChemoCentryx. “The drop in proteinuria seen in
the IgAN study presents a fourth potential application for our lead
drug candidate avacopan and the animal model study supports the
significant role of CCR2 inhibition in the treatment of FSGS.”
Decrease in Proteinuria in Patients Treated with Avacopan for
IgA Nephropathy (IgAN)
On June 6, 2017, researchers shared findings of a study
investigating the tolerability and efficacy of avacopan in the
treatment of IgA Nephropathy, also known as Berger’s Disease, where
immunoglobulin A (IgA) lodges in the kidney, causing proteinuria,
or excess protein in the urine. IgAN can lead to chronic
kidney disease, kidney failure and End Stage Renal Disease
(ESRD).
This open-label pilot Phase II trial in Sweden and the United
States investigated the tolerability and efficacy of ChemoCentryx’s
complement 5a receptor inhibitor avacopan (formerly CCX168) in IgAN
patients. After an 8-week run-in period on a maximum tolerated dose
of a renin-angiotensin-aldosterone system (RAAS) inhibitor,
patients started avacopan dosing, 30 mg twice daily for 12 weeks,
with a 12-week follow-up period. The primary efficacy endpoint was
change in slope of protein:creatinine ratio (UPCR) in the urine
from the run-in period to the avacopan treatment period. Seven
patients received avacopan treatment, and all 7 completed the
study. At the end of 12 weeks, reduced levels of protein in the
urine were seen in 6 of 7 patients, with 3 of the 7 patients
showing significant improvement to UPCR < 1 g/g. At the end of
the 12-week period following treatment, the protein ratio in 2 of
these 3 patients returned to baseline levels, while the improvement
was maintained in the third patient. One serious adverse event of
unstable angina was observed, considered unrelated to avacopan
treatment by the investigator. Longer avacopan treatment duration
may be indicated for maximal benefit. Avacopan appeared to be safe
and well tolerated.
“To see such a benefit on proteinuria, a key marker for IgA
Nephropathy, on top of a maximum tolerated dose of a RAAS
inhibitor, was quite encouraging,” said Annette Bruchfeld, M.D.,
Ph.D., from the Karolinska Institute in Stockholm. “With no
approved therapy for the disease available, avacopan presents a
promising potential treatment option for patients.”
Potential of CCR2 Inhibition as a Therapeutic Treatment Option
for Focal Segmental Glomerulosclerosis (FSGS)
In an oral presentation on June 6, 2017 titled “CCR2 Antagonism
Reduces Proteinuria and Glomerular Injury in Murine Models of Focal
Segmental Glomerulosclerosis (FSGS),” researchers discussed the
results of a study examining the efficacy of CCR2 inhibition in two
in vivo models. FSGS is another disease that causes proteinuria and
leads to ESRD. There is currently no approved treatment option for
FSGS.
Researchers concluded that blocking CCR2 provides marked and
rapid renal protection in two distinct models of FSGS, as measured
by reduction in proteinuria and improvement in multiple
histological parameters, and thus represents a novel and
mechanistically distinct approach for the treatment of
FSGS. The study support ChemoCentryx’s plans to conduct a
clinical endpoint study with CCR2 inhibitor CCX140 for FSGS, which
has already been shown to have good safety and tolerability in
hundreds of patients in clinical trials completed to date.
Abstracts of both studies can be found in the May 2017 issue of
Nephrology Dialysis Transplantation (NDT), the official journal of
the ERA-EDTA: https://academic.oup.com/ndt/issue
About Avacopan (CCX168)
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
successfully allowing elimination of high-dose steroids, part of
the standard of care for AAV patients. Avacopan is also being
developed in patients with atypical hemolytic uremic syndrome
(aHUS) and C3 glomerulopathy (C3G). 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 now granted
avacopan orphan-drug designation for all three of these diseases:
C3G, AAV, 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 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. Besides
avacopan (described above), the Company’s other late stage drug
candidate is CCX140, an inhibitor of the chemokine receptor known
as CCR2, which is currently being developed for patients with focal
segmental glomerulosclerosis (FSGS), a debilitating kidney
disease.
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 IgA nephropathy 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.
Contacts:
Susan M. Kanaya
Executive Vice President, Finance and 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
ChemoCentryx (NASDAQ:CCXI)
Historical Stock Chart
From Feb 2024 to Mar 2024
ChemoCentryx (NASDAQ:CCXI)
Historical Stock Chart
From Mar 2023 to Mar 2024