Celldex Therapeutics Announces Positive Topline Results from Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria
06 Noviembre 2023 - 5:30AM
Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today positive
topline 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 who received prior biologics. 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.
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 thrilled to share these positive results which we
believe further establish barzolvolimab as a potential
transformative treatment option for patients suffering with CSU,"
commented Anthony S. Marucci, President and Chief Executive Officer
of Celldex Therapeutics. "These data reinforce barzolvolimab's
unique mechanism targeting a key underlying pathway of the disease.
Based on the strength of these results, which included patients
refractory to omalizumab, we are excited to continue the
development of this program and move towards registrational trials.
We would like to thank the patients and investigators for their
participation in this trial and look forward to presenting full 12
week data from this study at an upcoming medical meeting.”
Data from the 208 patients randomized in the study showed that
barzolvolimab achieved the primary efficacy endpoint, with a
statistically significant mean change from baseline to week 12 of
UAS7 (urticaria activity score) compared to placebo. Barzolvolimab
demonstrated rapid, durable and clinically meaningful responses in
patients with moderate to severe CSU refractory to antihistamines,
including patients with prior omalizumab treatment. Demographics
and baseline disease characteristics were well balanced across
treatment groups.
Summary of Clinical Activity Assessments at Week
12 |
|
300 mg q8w(n=51) |
150 mg q4w(n=52) |
75 mg q4w(n=53) |
Placebo(n=51) |
UAS7 Changes |
Baseline UAS7 (mean) |
31.33 |
30.75 |
30.30 |
30.09 |
LS Mean change at Week 12 |
-23.87 |
-23.02 |
-17.06 |
-10.47 |
LS Mean difference from placebo (Confidence Interval, p value) |
-13.41 (CI: -17.47, -9.34)p<0.0001 |
-12.55(CI:-16.56, -8.55)p<0.0001 |
-6.60(CI:-10.71, -2.49)p=0.0017 |
|
Clinical Responses |
UAS7=0 (Complete Control) |
37.5% |
51.1% |
22.9% |
6.4% |
UAS7≤6 (Well-controlled) |
62.5% |
59.6% |
41.7% |
12.8% |
Approximately 20% of enrolled patients received prior treatment
with omalizumab. These patients experienced a similar clinical
benefit as the overall treated population within their individual
dosing groups.
Barzolvolimab was generally well tolerated with a favorable
safety profile. Most adverse events were mild to moderate in
severity; through 12 weeks, the most common treatment emergent
adverse events in barzolvolimab treated patients were hair color
changes (9%), urticaria (9%) and neutropenia (8%). The rate of
infections was similar between barzolvolimab-treated patients and
placebo with no apparent association between neutropenia and
infections.
Phase 2 Study Design 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. 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.
For additional information on this trial (NCT05368285), please
visit www.clinicaltrials.gov
Webcast and Conference Call The
Company will host a conference call/webcast today to discuss the
results at 8:00 a.m. 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. The call can also be accessed by
dialing (646) 307-1963 or (800) 715-9871 (toll free). The
conference ID is 3272134.
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 StatementThis 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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