Celldex Announces Upcoming Presentation of Barzolvolimab Phase 2 Results in Chronic Spontaneous Urticaria at AAAAI 2024
February 05 2024 - 8:01AM
Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that an
abstract describing 12 week results from the Company’s Phase 2
clinical trial of barzolvolimab in patients with moderate to severe
chronic spontaneous urticaria (CSU) refractory to antihistamines,
including patients with biologic-refractory disease, has been
accepted as a late breaking oral presentation at the American
Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting
2024 being held in Washington, DC on February 23-26, 2024.
Abstracts will be available on the meeting website today, February
5, 2024.
Presentation details are below:
Abstract Title: Barzolvolimab Significantly
Decreases Chronic Spontaneous Urticaria Disease Activity and is
Well Tolerated: Top Line Results from a Phase 2
TrialPresenting Author: Marcus Maurer, M.D.,
Professor of Dermatology and Allergy at Charité -
Universitätsmedizin in BerlinSession: Late
Breaking Oral Abstract SessionDate/Time: Saturday,
February 24 at 2:05 pm - 2:15 pm ET
The abstract is comprised of the topline 12-week primary
endpoint results the Company disclosed on November 6, 2023.
The Phase 2 randomized, double-blind, placebo-controlled,
parallel group 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. 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 period.
After 16 weeks, patients then enter a 36-week active treatment
period, 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 period. After 52 weeks,
patients then enter a follow-up period 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.
Webcast and Conference CallThe Company will
host a webcast presentation of the data on Sunday, February 25th at
9:45 AM ET. The event will be webcast live and can be accessed by
going to the "Events & Presentations” page under the "Investors
& Media" section of the Celldex Therapeutics website at
www.celldex.com.
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
and 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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