Assuming successful validation, the Company
currently expects to launch the pipeline test by the end of
2025
Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving
health through innovative tests that guide patient care, today
provided an update on its test currently in development for use in
patients diagnosed with moderate-to-severe atopic dermatitis (AD)
who are seeking systemic treatment. Based on preliminary data from
the Company’s ongoing prospective development and validation study,
Castle’s pipeline test has shown potential to identify a subset of
patients with AD who have an increased likelihood to achieve a
super response to targeted therapies, indicated by a 90% or greater
reduction in Eczema Area and Severity Index (EASI) score (EASI90)
at three months. Assuming successful validation, the Company
currently expects to launch its pipeline test by the end of
2025.
“It is estimated that there are more than six million patients
diagnosed with moderate-to-severe AD in the U.S. seeking treatment
annually, and approximately 760,000 of these patients seek systemic
treatment,” said Derek Maetzold, president and chief executive
officer of Castle Biosciences.1,2 “Today, once a clinician and
patient determine that systemic therapy is needed to control the
patient’s AD, a ‘trial-and-error’ treatment cycle begins. This
‘trial-and-error’ approach results in approximately 25% of patients
discontinuing their initial systemic therapy.3 Separately,
approximately 50% of patients who stay on their initial therapy
have indicators of persistent disease burden.4
“Data from our ongoing validation study for our pipeline test
suggests we may be able to improve the standard-of-care
‘trial-and-error’ treatment approach by identifying patients who
are more likely to achieve a super response to a specific class of
therapy based on identification of the immune pathway that is
driving their AD. By targeting validation of the test to predict a
90% or greater reduction in disease severity by three months,
instead of the traditional standard of 75% reduction, this test
provides information on an endpoint used in current drug
development that we anticipate will be more relevant for the future
(EASI90).
“Using a molecular test to identify the disease-driving immune
pathways and to inform the class of drugs a patient could initiate
based on increased likelihood of achieving a super response
provides a precision medicine tool to increase the number of
patients achieving a super response in less time by reducing
‘trial-and-error,’ which may reduce the utilization of healthcare
resources.”
Castle has enrolled more than 1,100 patients across 39 active
clinical study sites (as of Sept. 30, 2024) for this development
and validation study. Follow-up is ongoing with many of these
patients, as the Company is assessing response at three months,
which is the first typical timepoint for clinicians and patients to
determine if the current therapy is effective. Launch strategy
planning for the Company’s pipeline test, including selecting the
reimbursement pathway, is ongoing.
About Castle’s Atopic Dermatitis Pipeline
Program
Atopic dermatitis (AD) is among the most common inflammatory
skin condition, and patient quality of life is severely impacted by
this chronic disease. It is estimated that there are more than six
million patients diagnosed with moderate-to-severe AD in the U.S.
seeking treatment annually, and approximately 760,000 of these
patients seek systemic treatment. The Castle test in development
analyzes the expression of hundreds of genes to potentially
identify patients who have increased likelihood to achieve a super
response to targeted therapies, indicated by a 90% or greater
reduction in Eczema Area and Severity Index (EASI) score (EASI90)
at three months. Using a molecular test like Castle’s pipeline test
to identify the disease-driving immune pathways and to inform the
class of drugs a patient could initiate based on likelihood of
achieving a super response provides a precision medicine tool to
increase the number of patients achieving a super response in less
time by reducing trial-and-error, which may reduce the utilization
of healthcare resources.
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,
Barrett’s esophagus, mental health conditions and uveal melanoma.
Additionally, the Company has active research and development
programs for tests in these and other diseases with high clinical
need, including its test in development for use in patients
diagnosed with moderate-to-severe atopic dermatitis who are seeking
systemic treatment. To learn more, please visit
www.CastleBiosciences.com and connect with us on LinkedIn,
Facebook, X and Instagram.
DecisionDx-Melanoma, DecisionDx-CMSeq, i31-SLNB, i31-ROR,
DecisionDx-SCC, MyPath Melanoma, DiffDx-Melanoma, TissueCypher,
IDgenetix, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq 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 ability of Castle’s pipeline
AD gene expression profile test to (i) identify a subset of
patients with AD who have increased likelihood of achieving a super
response to targeted therapies, (ii) advance the disease state and
treatment response standards and (iii) help inform the class of
drugs a patient should initiate; and the timing and achievement of
anticipated operational milestones such as test validation,
determining a reimbursement pathway and test launch and
commercialization. The words “believe,” “can,” “could,” “potential”
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 or may not support the
results obtained in these studies, including with respect to the
discussion of our tests 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,
2023, our Quarterly Report on Form 10-Q for the quarter ended
September 30, 2024 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.
1
https://nationaleczema.org/research/eczema-facts/#:~:text=Overall%2C%2060%25%20of%20individuals%20with,10%25%20of%20children%20under%2018
2 Epidemiology of atopic dermatitis in adults: Results from an
international survey, Allergy.2018;1284–1293. DOI:
10.1111/all.13401 3 Eichenfield, L. F., DiBonaventura, M., Xenakis,
J., et al. (2020). Costs and treatment patterns among patients with
atopic dermatitis using advanced therapies in the United States:
Analysis of a retrospective claims database. Dermatology and
Therapy, 10, 791–806. https://doi.org/10.1007/s13555-020-00413-8 4
Quick, A. P., Hurton, L. V., Zolochevska, O., Farberg, A. S.,
Goldberg, M. S., & Silverberg, J. I. (2024). Contemporary
systemic treatment patterns in atopic dermatitis. British Journal
of Dermatology, 191(Suppl. 2).
https://doi.org/10.1093/bjd/ljae266.081
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version on businesswire.com: https://www.businesswire.com/news/home/20241223974000/en/
Investor Contact: Camilla Zuckero
czuckero@castlebiosciences.com
Media Contact: Allison Marshall
amarshall@castlebiosciences.com
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