Castle’s innovative pipeline initiative to
develop a genomic test aimed at guiding systemic therapy selection
for patients with moderate-to-severe atopic dermatitis, psoriasis
and related conditions is targeted to launch by the end of 2025
Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving
health through innovative tests that guide patient care, today
announced new data showing the ability of its pipeline test in
development to distinguish between responders and non-responders to
an atopic dermatitis (AD) therapy and also distinguish between AD,
psoriasis (PSO) and mycosis fungoides (MF) skin lesions.
The goal of Castle’s innovative pipeline initiative is to
develop a genomic test aimed at guiding systemic therapy selection
for patients with moderate-to-severe AD, PSO and related
conditions. Additional updates regarding development of this
pipeline program are expected in 2024.
“We are excited about our early results that show the ability of
our inflammatory skin disease pipeline program to distinguish
between patients diagnosed with moderate-to-severe AD who will
respond and who will not respond to an AD systemic therapy,” said
Robert Cook, Ph.D., senior vice president of research and
development at Castle Biosciences. “We look forward to additional
development data in 2024 and are targeting launch of the test by
the end of 2025.”
“A test of this type would be a significant step forward in the
care of patients suffering from these debilitating conditions,”
added Aaron Farberg, M.D., FAAD, lead poster author and
double-board certified dermatologist, Mohs surgeon and chief
medical officer of Bare Dermatology in Dallas. “The test’s results
could help clinicians personalize therapy selection for patients
based on their molecular profile and potentially help spare them
from enduring multiple ineffective and expensive medication courses
before finding one that controls their symptoms.”
Castle shared data regarding its innovative pipeline initiative
at the recent 2023 Fall Clinical Dermatology Conference® (FC23). In
addition to therapy responder data in patients diagnosed with AD,
the Company also presented data confirming that gene expression
differences exist between AD, PSO and MF skin lesions which could
assist clinicians in making an appropriate diagnosis. This is
clinically significant as incorrectly treating inflammatory skin
diseases can not only delay a critical diagnosis but may further
complicate a patient’s disease if incorrectly prescribed a
medication for the wrong condition.
Additional updates regarding development of this pipeline
program are expected in 2024. Castle’s poster from FC23 may be
viewed here.
About Castle’s Inflammatory Skin Disease Pipeline
Test
Inflammatory skin disease accounts for a significant number of
patient visits to both primary care and dermatology clinics across
the United States every year. Psoriasis (PSO) and atopic dermatitis
(AD) are among the most common inflammatory skin conditions, and
patient quality of life is severely impacted by these chronic
diseases. Fortunately, systemic medications developed over the past
15 years have demonstrated a significant improvement in patients’
lives. In the United States alone, there are about 18 million
patients diagnosed with PSO and AD, and approximately 450,000
patients annually are eligible for these systemic therapies. While
there are now many effective treatment options available for those
with moderate-to-severe inflammatory skin diseases, current
clinical practice relies on a trial-and-error approach for therapy
selection.
To answer this unmet clinical need, in 2021, Castle initiated a
prospective, multi-center clinical study (IDENTITY) to develop and
validate a gene expression profile (GEP) test to help guide
systemic therapy selection for patients with moderate-to-severe AD,
PSO and other related diseases. In 2022, the Company initiated a
second, prospective study (SIGNAL-MF) to investigate the
possibility of the pipeline test including an ancillary component
to help identify lesions that may be MF, a rare and serious type of
skin cancer, often referred to as cutaneous T-cell lymphoma, that
is easily mistaken for AD and PSO. MF requires a rigorous
histologic and molecular workup to diagnose, and patients with MF
being treated for presumed AD or PSO can further delay this
critical diagnosis.
More information about Castle’s tests can be found at
www.CastleTestInfo.com.
About Castle Biosciences
Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics
company improving health through innovative tests that guide
patient care. The Company aims to transform disease management by
keeping people first: patients, clinicians, employees and
investors.
Castle’s current portfolio consists of tests for skin cancers,
uveal melanoma, Barrett’s esophagus and mental health conditions.
Additionally, the Company has active research and development
programs for tests in other diseases with high clinical need,
including its test in development to help guide systemic therapy
selection for patients with moderate-to-severe atopic dermatitis,
psoriasis and related conditions.
To learn more, please visit www.CastleBiosciences.com and
connect with us on LinkedIn, Facebook, X and Instagram.
DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, MyPath
Melanoma, DecisionDx-UM, DecisionDx-PRAME, DecisionDx-UMSeq,
TissueCypher and IDgenetix are trademarks of Castle Biosciences,
Inc.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended, which are subject to the “safe harbor” created by those
sections. These forward-looking statements include, but are not
limited to, statements concerning: the continued ability to use the
Company’s inflammatory skin disease pipeline test to distinguish
between responders and non-responders to an AD therapy and also
distinguish between AD, PSO and MF skin lesions; the ability of the
pipeline test to help clinicians personalize therapy selection for
patients based on their molecular profile and potentially help
spare them from enduring multiple ineffective and expensive
medication courses; the timing of data releases and updates; the
ability of the Company’s initial test iteration to identify
super-responder patients with moderate-to-severe AD; and the timing
of the launch of the initial iteration of the Company’s
inflammatory skin disease pipeline test. The words “can,” “may” and
similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. We may not actually achieve the plans,
intentions or expectations disclosed in our forward-looking
statements, and you should not place undue reliance on our
forward-looking statements. Actual results or events could differ
materially from the plans, intentions and expectations disclosed in
the forward-looking statements that we make. These forward-looking
statements involve risks and uncertainties that could cause our
actual results to differ materially from those in the
forward-looking statements, including, without limitation:
subsequent study or trial results and findings may contradict
earlier study or trial results and findings, including with respect
to the discussion of the Company’s inflammatory skin disease
pipeline test in this press release; actual application of our
tests may not provide the aforementioned benefits to patients; and
the risks set forth under the heading “Risk Factors” in our Annual
Report on Form 10-K for the year ended December 31, 2022, our
Quarterly Report on Form 10-Q for the three months ended June 30,
2023, and in our other filings with the SEC. The forward-looking
statements are applicable only as of the date on which they are
made, and we do not assume any obligation to update any
forward-looking statements, except as may be required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20231102811020/en/
Investor Contact: Camilla Zuckero
czuckero@castlebiosciences.com
Media Contact: Allison Marshall
amarshall@castlebiosciences.com
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