Celldex Therapeutics Presents Positive Data from Prurigo Nodularis Phase 1b Study Demonstrating Meaningful Reduction in Itch and Skin Clearing with Single Dose 3.0 mg/kg Barzolvolimab
06 November 2023 - 7:00AM
Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced data from
the Company’s Phase 1b 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. This study is the first to
demonstrate that barzolvolimab, a mast cell depleting agent, can
potentially be used to treat PN and other chronic itch indications.
The data will be presented in an oral presentation during the “Hot
Topics” Session at the 12th World Congress on Itch (WCI) 2023 on
Tuesday, November 7th by Martin Metz, M.D., Professor of
Dermatology and Allergy at Charité - Universitätsmedizin in Berlin.
Abstracts accepted for presentation at the meeting were released
today.
“Prurigo nodularis is a miserable disease where we desperately
need treatment options that offer early and durable relief for our
patients by not only reducing the relentless itching but also
healing the painful lesions that are the hallmark of prurigo
nodularis,” said Dr. Martin Metz. “These very promising results
demonstrate that barzolvolimab and its novel mast cell depleting
mechanism could play a meaningful role in breaking the stubborn
scratch/itch cycle of this disease and potentially other itch
driven conditions. With a single dose, we were able to elicit
remarkable clinical results and look forward to what lies ahead in
multi-dose studies.”
“Today’s exciting results in prurigo nodularis add to our strong
body of clinical evidence in chronic urticaria and clearly point to
barzolvolimab’s significant opportunity to meet the needs of the
multitudes of patients with mast cell mediated diseases,” said
Anthony Marucci, President and Chief Executive Officer of Celldex
Therapeutics. “We look forward to advancing this program in a Phase
2 study to start early next year as we also seek to expand our
leadership into additional mast cell mediated indications.”
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.
Summary of Barzolvolimab Phase 1b Prurigo Nodularis
Study Results
The Phase 1b double-blind, single intravenous (IV) dose study
randomized 24 adults (evaluable: n=23 safety; n=22 efficacy) with
moderate to severe PN across three arms: (1) barzolvolimab 3.0
mg/kg (n=9), barzolvolimab 1.5 mg/kg (n=7) and placebo (n=8). The
primary endpoint of the study was safety; key secondary endpoints
include changes from baseline in Worst Itch-Numerical Rating Scale
(WI-NRS) & Investigator Global Assessment (IGA). The primary
timepoint for evaluation of clinical activity was 8 weeks; patients
were followed for safety and efficacy endpoints to 24 weeks.
Patients on study generally had moderate to severe disease with
mean baselines scores across all arms of 8.6 for WI-NRS and 3.3 for
IGA.
- These data show that a single IV dose of 3.0 mg/kg
barzolvolimab resulted in rapid and durable reductions in itch and
healing of skin lesions in patients with moderate to severe PN and
that barzolvolimab was generally well tolerated. A Phase 2
subcutaneous multi-dose study is planned for initiation in early
2024.
- At week 8, the percentage of patients with ≥4-point decrease in
WI-NRS was 57% and 43% for the single dose 3.0 or 1.5 mg/kg
barzolvolimab arms, respectively, and 25% for the placebo arm; this
level of response generally persisted out to week 16. In the 3.0
mg/kg arm, a ≥4-point decrease in WI-NRS reduction was seen as
early as the first week and reached a high of 71% of patients at
week six which was distinct from both the 1.5 mg/kg barzolvolimab
and placebo arms.
% of Subjects with ≥4-point decrease in
WI-NRS |
Dose |
Week 1 |
Week 2 |
Week 3 |
Week 4 |
Week 5 |
Week 6 |
Week 7 |
Week 8 |
1.5 mg/kg |
0 |
14 |
29 |
14 |
29 |
29 |
29 |
43 |
3.0 mg/kg |
14 |
29 |
29 |
29 |
57 |
71 |
57 |
57 |
placebo |
0 |
0 |
13 |
13 |
25 |
38 |
38 |
25 |
- At week 8, 29% of patients achieved clear or almost clear skin
according to IGA following a single dose of barzolvolimab 3.0
mg/kg. This effect was noted as early as week 2 (the first clinic
visit) and was maintained out to week 12/16. No patients treated at
1.5 mg/kg barzolvolimab or placebo achieved clear or almost clear
skin according to IGA through week 8. 2 additional patients in the
1.5 mg/kg arm, 2 additional patients in the 3.0 mg/kg arm and 1
patient on placebo had IGA 0/1 at timepoints between weeks 8 and
24.
% of Subjects with IGA 0/1 |
Dose |
Baseline |
Week 2 |
Week 4 |
Week 8 |
1.5 mg/kg |
0 |
0 |
0 |
0 |
3.0 mg/kg |
0 |
14 |
14 |
29 |
placebo |
0 |
0 |
0 |
0 |
- Clinical activity was associated with profound serum tryptase
reduction. At the 3.0 mg/kg dose, tryptase was profoundly reduced
to, or below, the level of quantification and this level of
reduction was maintained at least through 8 weeks. Tryptase
reduction was observed in the 1.5 mg/kg arm but to a lesser
extent.
- Adverse Events (AEs) were generally mild to moderate in
intensity and considered unrelated to treatment. During the initial
8 week observation period in the 3.0 mg/kg dosing arm, as
previously disclosed, an anaphylactic reaction occurred in a
complicated patient with multiple comorbidities; the event fully
resolved without sequelae. Generally, AEs seen during the 24-week
follow-up period were consistent with comorbidities commonly
observed in the PN population.
Webcast and Conference CallThe Company will
host a conference call/webcast to discuss the results on Monday 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 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 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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