Celldex Announces Completion of Enrollment in Phase 2 Study of Barzolvolimab in Patients with Chronic Spontaneous Urticaria
11 Juillet 2023 - 2:01PM
Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that
patient enrollment has been completed in the Company’s Phase 2
clinical study of barzolvolimab for the treatment of chronic
spontaneous urticaria (CSU). Barzolvolimab is a humanized
monoclonal antibody that specifically binds the receptor tyrosine
kinase KIT with high specificity and potently inhibits its
activity, which is required for the function and survival of the
mast cell. CSU is characterized by the occurrence of hives or
wheals for 6 weeks or longer without identifiable specific triggers
or causes. Treatment options for patients with CSU are limited and
there are no approved therapies for patients who do not respond to
omalizumab.
"We are extremely grateful to the investigators and patients who
supported this trial and are pleased that we were able to complete
enrollment well ahead of schedule," said Anthony Marucci, President
and Chief Executive Officer of Celldex Therapeutics. "CSU is an
often serious and debilitating disease with significant impacts on
patient quality of life, and there is a high unmet need for new
treatment options. We believe barzolvolimab holds significant
promise as a potential new treatment for patients with chronic
urticarias and look forward to presenting topline data from the CSU
study before the end of the year."
The randomized, double-blind, placebo-controlled, parallel group
Phase 2 study is evaluating the efficacy and safety profile of
multiple dose regimens of barzolvolimab in patients with CSU who
remain symptomatic despite antihistamine therapy, to determine the
optimal dosing strategy. Given strong interest in the study,
enrollment projections were exceeded and 208 patients were randomly
assigned on a 1:1:1:1 ratio to receive subcutaneous injections of
barzolvolimab at 75 mg every 4 weeks, 150 mg every 4 weeks, 300 mg
every 8 weeks or placebo during a 16-week placebo-controlled
treatment phase. After 16 weeks, patients then enter a 36-week
active treatment phase, in which patients not already randomized to
barzolvolimab at 150 mg every 4 weeks or 300 mg every 8 weeks are
randomized 1:1 to receive one of these two dose regimens; patients
already randomized to these treatment arms remain on the same
regimen as during the placebo-controlled treatment phase. After 52
weeks, patients then enter a follow-up phase for an additional 24
weeks. The primary endpoint of the study is mean change in baseline
to Week 12 in UAS7. Secondary endpoints include other assessments
of safety and clinical activity including ISS7, HSS7 and AAS7.
For additional information on this trial (NCT05368285), please
visit www.clinicaltrials.gov.
About Chronic Spontaneous Urticaria (CSU)CSU is
characterized by the occurrence of hives or wheals for 6 weeks or
longer without identifiable specific triggers or causes. The
activation of the mast cells in the skin (release of histamines,
leukotrienes, chemokines) results in episodes of itchy hives,
swelling and inflammation of the skin that can go on for years or
even decades. Current therapies provide symptomatic relief only in
some patients.
About BarzolvolimabBarzolvolimab is a humanized
monoclonal antibody that binds the receptor tyrosine kinase KIT
with high specificity and potently inhibits its activity. KIT is
expressed in a variety of cells, including mast cells, which
mediate inflammatory responses such as hypersensitivity and
allergic reactions. KIT signaling controls the differentiation,
tissue recruitment, survival and activity of mast cells. In certain
inflammatory diseases, such as chronic urticaria, mast cell
activation plays a central role in the onset and progression of the
disease.
About Celldex Therapeutics, Inc.Celldex is a
clinical stage biotechnology company dedicated to developing
monoclonal and bispecific antibodies that address devastating
diseases for which available treatments are inadequate. Our
pipeline includes antibody-based therapeutics which have the
ability to engage the human immune system and/or directly affect
critical pathways to improve the lives of patients with
inflammatory diseases and many forms of cancer. Visit
www.celldex.com.
Forward Looking Statement This release contains
"forward-looking statements" made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
These statements are typically preceded by words such as
"believes," "expects," "anticipates," "intends," "will," "may,"
"should," or similar expressions. These forward-looking statements
reflect management's current knowledge, assumptions, judgment and
expectations regarding future performance or events. Although
management believes that the expectations reflected in such
statements are reasonable, they give no assurance that such
expectations will prove to be correct or that those goals will be
achieved, and you should be aware that actual results could differ
materially from those contained in the forward-looking statements.
Forward-looking statements are subject to a number of risks and
uncertainties, including, but not limited to, our ability to
successfully complete research and further development and
commercialization of Company drug candidates, including
barzolvolimab (also referred to as CDX-0159), in current or future
indications; the uncertainties inherent in clinical testing and
accruing patients for clinical trials; our limited experience in
bringing programs through Phase 3 clinical trials; our ability to
manage and successfully complete multiple clinical trials and the
research and development efforts for our multiple products at
varying stages of development; the effects of the outbreak of
COVID-19 on our business and results of operations; the
availability, cost, delivery and quality of clinical materials
produced by our own manufacturing facility or supplied by contract
manufacturers, who may be our sole source of supply; the timing,
cost and uncertainty of obtaining regulatory approvals; the failure
of the market for the Company's programs to continue to develop;
our ability to protect the Company's intellectual property; the
loss of any executive officers or key personnel or consultants;
competition; changes in the regulatory landscape or the imposition
of regulations that affect the Company's products; our ability to
continue to obtain capital to meet our long-term liquidity needs on
acceptable terms, or at all, including the additional capital which
will be necessary to complete the clinical trials that we have
initiated or plan to initiate; and other factors listed under "Risk
Factors" in our annual report on Form 10-K and quarterly reports on
Form 10-Q.
All forward-looking statements are expressly qualified in their
entirety by this cautionary notice. You are cautioned not to place
undue reliance on any forward-looking statements, which speak only
as of the date of this release. We have no obligation, and
expressly disclaim any obligation, to update, revise or correct any
of the forward-looking statements, whether as a result of new
information, future events or otherwise.
Company ContactSarah CavanaughSenior Vice
President, Corporate Affairs & Administration(508)
864-8337scavanaugh@celldex.com
Patrick TillMeru Advisors (484)
788-8560ptill@meruadvisors.com
Celldex Therapeutics (NASDAQ:CLDX)
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