Celldex Announces First Patient Dosed in Phase 2 Study of Barzolvolimab in Prurigo Nodularis
15 Maggio 2024 - 2:01PM
Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the
first patient has been dosed in the Company’s Phase 2 subcutaneous
study of barzolvolimab in prurigo nodularis (PN). 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. Mast cells are believed to play an
important role in amplifying chronic itch and neuroinflammation,
including in PN where mast cells are associated with pruritic
sensory neurons in PN lesions.
In November 2023, Celldex presented first in class data from the
Company’s Phase 1b study in PN demonstrating that barzolvolimab and
its novel mast cell depleting mechanism could play a meaningful
role in breaking the stubborn scratch/itch cycle of this disease,
resulting in lesion healing.
“Prurigo nodularis is a miserable disease and treatment options
are desperately needed that offer early and durable relief by both
reducing the relentless itching associated with the disease and
allowing for healing of the painful lesions that are the hallmark
of PN,” said Diane C. Young, M.D, Senior Vice President and Chief
Medical Officer of Celldex Therapeutics. “In our Phase 1b PN study,
with just a single dose of barzolvolimab, we demonstrated
remarkable clinical results. We are very excited to see what
multiple doses of barzolvolimab may offer patients in this
important Phase 2 study.”
The randomized, double-blind, placebo-controlled, parallel group
study is evaluating the efficacy and safety profile of 2 dose
levels of barzolvolimab compared to placebo in approximately 120
patients with moderate to severe PN who had inadequate response to
prescription topical medications, or for whom topical medications
are medically inadvisable (such as concerns for safety), including
patients who received prior biologics. Patients will be randomly
assigned on a 1:1:1 ratio to receive barzolvolimab injections of
150 mg Q4W after an initial loading dose of 450 mg, 300 mg Q4W
after an initial loading dose of 450 mg, or placebo during a
24‑week treatment phase. Participants will then enter a follow-up
phase with no study treatment for an additional 16 weeks through
week 40. The primary objective of this study is to evaluate the
clinical effect of barzolvolimab, compared to placebo, on itch
response as measured by the proportion of participants with ≥
4-point improvement in the worst intensity itch per a numeric
rating scale (WI-NRS). Secondary objectives include but are not
limited to additional measures of itch response from baseline
compared to different timepoints, the assessment of skin lesions as
measured by the Investigator Global Assessment (IGA), QoL outcomes
and safety. The study will include approximately 50 clinical trial
centers worldwide, including the United States.
For additional information on this trial (NCT06366750), please
visit www.clinicaltrials.gov.
About Prurigo Nodularis (PN)PN is a chronic
skin disease that causes hard, intensely itchy lumps/nodules to
form on the skin. The itching (pruritus) can be intense, causing
people to scratch themselves to the point of bleeding or pain,
which can form lesions and perpetuate the disease cycle. With
limited treatment options available, PN is also associated with
significant impact on quality of life including sleep disturbance,
psychological distress, social isolation, anxiety and depression.
Mast cells are believed to play an important role in amplifying
chronic itch and neuroinflammation, including in PN where mast
cells are associated with pruritic sensory neurons in PN
lesions.
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, including atopic
dermatitis (AD).
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 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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