ChemoCentryx, Inc., (Nasdaq: CCXI), today announced planned
presentations covering TAVNEOS® (avacopan), an orally administered
selective complement 5a receptor (C5aR) inhibitor, at the American
Society of Nephrology (ASN) Kidney Week 2022 and American College
of Rheumatology (ACR) Convergence 2022 annual meetings taking place
in November.
American Society of Nephrology Kidney Week 2022,
November 3-6, Orlando Renal Recovery for Patients with
Baseline eGFR ≤20 in Avacopan ADVOCATE Trial |
|
Session Title: Glomerular Diseases: Clinical,
Outcomes, Trials - II Abstract Number:
FR-PO651Presenter: Frank Cortazar,
M.D.Date and Time: November 4, 2022, 10:00 a.m. -
12:00 p.m. ETLocation: Exhibit Hall, West
Building |
|
Integrated Safety of Avacopan in ANCA-Associated
Vasculitis |
|
Session Title: Glomerular Diseases: Clinical,
Outcomes, Trials - III Abstract Number:
SA-PO696Presenter: David Jayne, M.D.Date
and Time: November 5, 2022, 10:00 a.m. - 12:00 p.m.
ETLocation: Exhibit Hall, West Building |
|
Kidney C5aR is Expressed in Resident Macrophages, Tubular
Epithelial Cells, and in Association with Fibrosis |
|
Session Title: Glomerular Diseases: IgA and
Complement-Mediated GN Abstract Number:
SA-PO633Presenter: Carolyn DunlapDate and
Time: November 5, 2022, 10:00 a.m. - 12:00 p.m.
ETLocation: Exhibit Hall, West Building |
|
ASN Kidney Week posters are viewable as ePosters during the
entire conference for conference registrants. |
|
American College of Rheumatology Convergence 2022,
November 10-14, PhiladelphiaRecovery of Renal Function
Among ANCA-Associated Vasculitis Patients with Baseline eGFR ≤20 in
the Avacopan ADVOCATE Trial |
|
Session Title: Abstracts: Vasculitis –
ANCA-AssociatedAbstract Number:
525Presenter: Frank Cortazar, M.D.Oral
Presentation Date and Time: November 12, 2022, 3:15 - 3:25
p.m. ETLocation: Room 103 |
|
ANCA-Associated Vasculitis Treated with Avacopan versus a
Standard Prednisone Taper: Glucocorticoid Toxicity Index Scores by
Domain |
|
Session Title: Vasculitis – ANCA-Associated Poster
II: Treatment Efficacy, Clinical Outcomes,
BiomarkersAbstract Number:
1076Presenter: Naomi Patel, M.D.Ignite
Talk Date and Time: November 13, 2022, 10:10 - 10:15 a.m.
ETLocation: Stage A |
|
Safety of Avacopan in ANCA-Associated Vasculitis: Combined Data
from Three Clinical Trials |
|
Session Title: Vasculitis – ANCA-Associated Poster
II: Treatment Efficacy, Clinical Outcomes,
BiomarkersAbstract Number:
1077Presenter: Peter Merkel, M.D.,
MPHIgnite Talk Date and Time: November 13, 2022,
10:15 - 10:20 a.m. ETLocation: Stage A |
|
Glucocorticoid Use and Related Adverse Events in ADVOCATE Trial
of Avacopan in ANCA-Associated Vasculitis |
|
Session Title: Vasculitis – ANCA-Associated Poster
II: Treatment Efficacy, Clinical Outcomes,
BiomarkersAbstract Number:
1078Presenter: Emil deGoma, M.D.Poster
Session Date and Time: November 13, 2022, 9:00 – 10:30
a.m. ETLocation: Virtual |
|
ACR Convergence posters are viewable as ePosters during the
entire conference for conference registrants. |
INDICATION
TAVNEOS® (avacopan) is indicated as an adjunctive treatment of
adult patients with severe active anti-neutrophil cytoplasmic
autoantibody (ANCA)-associated vasculitis (granulomatosis with
polyangiitis [GPA] and microscopic polyangiitis [MPA]) in
combination with standard therapy including glucocorticoids.
TAVNEOS does not eliminate glucocorticoid use.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Serious hypersensitivity to avacopan or to any of the
excipients.
WARNINGS AND PRECAUTIONS
Hepatotoxicity: Serious cases of hepatic injury have been
observed in patients taking TAVNEOS, including life-threatening
events. Obtain liver test panel before initiating TAVNEOS, every 4
weeks after start of therapy for six months and as clinically
indicated thereafter. Monitor patients closely for hepatic adverse
reactions and consider pausing or discontinuing treatment as
clinically indicated (refer to section 5.1 of the Prescribing
Information). TAVNEOS is not recommended for patients with active,
untreated and/or uncontrolled chronic liver disease (e.g., chronic
active hepatitis B, untreated hepatitis C, uncontrolled autoimmune
hepatitis) and cirrhosis. Consider the risk and benefit before
administering this drug to a patient with liver disease.
Serious Hypersensitivity Reactions: Cases of angioedema occurred
in a clinical trial, including one serious event requiring
hospitalization. Discontinue immediately if angioedema occurs and
manage accordingly. TAVNEOS must not be re-administered unless
another cause has been established.
Hepatitis B Virus (HBV) Reactivation: Hepatitis B reactivation,
including life threatening hepatitis B, was observed in the
clinical program. Screen patients for HBV. For patients with
evidence of prior infection, consult with physicians with expertise
in HBV and monitor during TAVNEOS therapy and for six months
following. If patients develop HBV reactivation, immediately
discontinue TAVNEOS and concomitant therapies associated with HBV
reactivation and consult with experts before resuming.
Serious Infections: Serious infections, including fatal
infections, have been reported in patients receiving TAVNEOS. The
most common serious infections reported in TAVNEOS group were
pneumonia and urinary tract infections. Avoid use of TAVNEOS in
patients with active, serious infection, including localized
infections. Consider the risks and benefits before initiating
TAVNEOS in patients with chronic infection, at increased risk of
infection or who have been to places where certain infections are
common.
ADVERSE REACTIONS
The most common adverse reactions (≥5% of patients and higher in
the TAVNEOS group vs. prednisone group) were: nausea, headache,
hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal
pain, dizziness, blood creatinine increased and paresthesia.
DRUG INTERACTIONS
Avoid coadministration of TAVNEOS with strong and moderate
CYP3A4 enzyme inducers. Reduce TAVNEOS dose when co-administered
with strong CYP3A4 enzyme inhibitors to 30 mg once daily. Monitor
for adverse reactions and consider dose reduction of certain
sensitive CYP3A4 substrates.
Please see Full Prescribing Information and Medication
Guide for TAVNEOS.
About TAVNEOS®
(avacopan)
TAVNEOS (avacopan), approved by the FDA as an adjunctive
treatment of ANCA-associated vasculitis, is a first-in-class,
orally administered small molecule that employs a novel, highly
targeted mode of action in complement-driven autoimmune and
inflammatory diseases. While the precise mechanism in ANCA
vasculitis has not been definitively established, TAVNEOS, by
blocking the complement 5a receptor (C5aR) for the pro-inflammatory
complement system fragment known as C5a on destructive inflammatory
cells such as blood neutrophils, is presumed to arrest the ability
of those cells to do damage in response to C5a activation, which is
known to be the driver of ANCA vasculitis. TAVNEOS’s selective
inhibition of only the C5aR is believed to leave the beneficial C5a
pathway through the C5L2 receptor functioning normally.
ChemoCentryx is also developing TAVNEOS for the treatment of
patients with C3 glomerulopathy (C3G), severe hidradenitis
suppurativa (HS), and lupus nephritis (LN). The US Food and Drug
Administration granted TAVNEOS orphan drug designation for
ANCA-associated vasculitis and C3G. The European Commission has
granted orphan medicinal product designation for TAVNEOS 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. TAVNEOS has not
been approved for indications discussed as in development, and the
safety and efficacy of those uses has not been established.
About ANCA-Associated Vasculitis
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 ChemoCentryx
ChemoCentryx is a biopharmaceutical company commercializing
and 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. In the United States,
ChemoCentryx markets TAVNEOS® (avacopan), the first approved
orally administered inhibitor of the complement 5a receptor as an
adjunctive treatment for adult patients with severe active
ANCA-associated vasculitis. TAVNEOS is also in late-stage clinical
development for the treatment of severe hidradenitis suppurativa
(HS) and C3 glomerulopathy (C3G).
ChemoCentryx is also developing CCX559, a highly potent
orally administered small molecule PD-L1 checkpoint inhibitor, for
the treatment of patients with solid tumors. A Phase I dose
escalation study for CCX559 is ongoing
and ChemoCentryx plans to advance to a Phase Ib/II study
in early 2023.
Additionally, ChemoCentryx has early-stage drug
candidates that target chemoattractant receptors in other
inflammatory and autoimmune diseases and in cancer. For more
information about the Company visit www.ChemoCentryx.com.
TAVNEOS® is a registered trademark of ChemoCentryx,
Inc. For more information, please see the Full
Prescribing Information and Medication Guide, available
at TAVNEOS.com.
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 regarding the achievement of anticipated goals and
milestones. 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 1, 2022, 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.
ChemoCentryx Contacts
Investors:Bill Slattery, Jr.Vice President,
Investor Relations& Corporate
Communications650.210.2970bslattery@chemocentryx.com
Media:Alex StrausInvestor Relations &
Corporate Communications Managerastraus@chemocentryx.com
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