Celldex Announces Completion of Enrollment in Phase 2 Study of Barzolvolimab in Patients with Chronic Inducible Urticaria
17 Aprile 2024 - 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 the two most
common forms of chronic inducible urticaria (CIndU)—cold urticaria
(ColdU) and symptomatic dermographism (SD). CIndU is characterized
by the occurrence of hives or wheals that have an attributable
trigger associated with them—temperatures below skin temperature in
ColdU and scratching/rubbing of the skin in SD. Mast cell
activation is known to be a critical driver in ColdU and SD.
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 mast cell
function and survival. In February 2024, the Company presented
positive 12 week primary endpoint results from its ongoing Phase 2
study of barzolvolimab in the most common form of chronic
urticaria—chronic spontaneous urticaria (CSU).
"We are very grateful to all the investigators and patients who
supported this trial," said Anthony Marucci, President and Chief
Executive Officer of Celldex Therapeutics. "While individuals with
inducible urticaria go to great lengths to avoid disease triggers
in their daily lives, many find it impossible to do so and are
severely burdened by this disease. This is compounded by the fact
that there are currently no approved therapies for CIndU other than
antihistamines. We believe barzolvolimab holds significant promise
as a much needed potential treatment for patients with CIndU and
look forward to presenting topline data from this study in the
second half 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 CIndU who
remain symptomatic despite antihistamine therapy, to determine the
optimal dosing strategy. 196 patients in 2 cohorts (differentiated
by CIndU subtype) including 97 patients with ColdU and 99 patients
with SD were randomly assigned on a 1:1:1 ratio to receive
subcutaneous injections of barzolvolimab at 150 mg every 4 weeks,
300 mg every 8 weeks or placebo during a 20-week treatment phase.
Patients then enter a follow-up phase for an additional 24 weeks.
The primary endpoint of the study is the percentage of patients
with a negative provocation test at Week 12 (using TempTest® for
ColdU and FricTest® for SD). Secondary endpoints include safety and
other assessments of clinical activity including CTT (critical
temperature threshold), CFT (critical friction threshold) and
WI-NRS (worst itch numeric rating scale).
For additional information on this trial (NCT05405660), please
visit www.clinicaltrials.gov.
About Chronic Inducible Urticaria (CIndU)CIndU
is characterized by the occurrence of hives or wheals that have an
attributable trigger associated with them. ColdU symptoms include
itching, burning wheals and angioedema when skin is exposed to
temperatures below skin temperature. SD symptoms include the
development of wheals and a flare reaction in response to stroking,
scratching or rubbing of the skin. Approximately 0.5% of the total
population suffers from chronic inducible urticarias. There are
currently no approved therapies for chronic inducible urticarias
other than antihistamines and patients attempt to manage symptoms
associated with their disease through avoidance of triggers.
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. Barzolvolimab is currently being studied in chronic
spontaneous urticaria (CSU), chronic inducible urticaria (CIndU),
prurigo nodularis (PN) and eosinophilic esophagitis (EOE) with
additional indications planned for the future.
About Celldex Therapeutics, Inc.Celldex is a
clinical stage biotechnology company leading the science at the
intersection of mast cell biology and the development of
transformative therapeutics for patients. 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 severe inflammatory, allergic,
autoimmune and other devastating diseases. 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
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