ChemoCentryx, Inc., (Nasdaq: CCXI), today announced upcoming
presentations at three key medical conferences that will highlight
findings from the pivotal Phase III ADVOCATE trial that supported
the approval of TAVNEOS® (avacopan), an orally administered
selective complement 5a receptor (C5aR) inhibitor, and research
into the burden of glucocorticoid use in ANCA-associated
vasculitis.
ATS 2022 (American Thoracic Society), May 15-17, San
FranciscoInsights from the ADVOCATE Study: Respiratory
Tract Involvement in Patients with ANCA-Associated Vasculitis in a
Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of
Avacopan Tuesday, May 17 at 3:15 PM PTRoom 11-12, South Building,
Exhibition Level, Moscone Center Session: Mini Symposium: Clinical
Trials in Chronic Lung Disease
ISPOR 2022 (International Society for Pharmacoeconomics
and Outcomes Research), May 15-18, Washington, DC/Virtual
The Burden of Systemic Glucocorticoid (GC) Use in Anti-Neutrophilic
Cytoplasmic Autoantibody (ANCA)-Associated Vasculitis
PatientsTuesday, May 17 from 5:30 - 6:30 PM ETPrince George Exhibit
Hall, Area A
59th ERA Conference
(European Renal Association), May 19-22, Paris,
France/Virtual Incidence of Infections in the Avacopan
Group Versus Prednisone Group in ANCA-Associated Vasculitis,
Results from the Phase 3 ADVOCATE Study Friday, May 20 from 5:00 PM
– 6:30 PM CESTSession: New insights from clinical trials in
ANCA-associated vasculitis
INDICATIONTAVNEOS® (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
CONTRAINDICATIONSSerious hypersensitivity to
avacopan or to any of the excipients
WARNINGS AND PRECAUTIONSHepatotoxicity: 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 REACTIONSThe 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 VasculitisANCA-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).
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.
Contacts:
Investors:Bill Slattery, Jr.Vice President,
Investor Relations& Corporate
Communications650.210.2970bslattery@chemocentryx.com
Media:Stephanie
Tomei408.234.1279media@chemocentryx.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