STOCK TITAN

Castle Biosciences Highlights Progress for its Pipeline Atopic Dermatitis Gene Expression Profile Test

Rhea-AI Impact
(Neutral)
Rhea-AI Sentiment
(Neutral)
Tags

Castle Biosciences (CSTL) provided an update on its pipeline test for moderate-to-severe atopic dermatitis (AD) patients seeking systemic treatment. Preliminary data shows the test may identify patients likely to achieve a super response (90% or greater reduction in EASI score) to targeted therapies within three months.

The company has enrolled over 1,100 patients across 39 clinical study sites for its development and validation study. With an estimated 6 million U.S. patients diagnosed with moderate-to-severe AD annually, and approximately 760,000 seeking systemic treatment, the test aims to improve the current 'trial-and-error' approach, where 25% of patients discontinue initial therapy and 50% show persistent disease burden.

Assuming successful validation, Castle expects to launch the test by the end of 2025.

Castle Biosciences (CSTL) ha fornito un aggiornamento sul suo test di pipeline per pazienti con dermatite atopica (AD) da moderata a grave in cerca di trattamento sistemico. I dati preliminari mostrano che il test potrebbe identificare i pazienti che hanno maggiori probabilità di ottenere una super risposta (riduzione del punteggio EASI del 90% o più) a terapie mirate entro tre mesi.

L'azienda ha arruolato oltre 1.100 pazienti in 39 siti di studio clinico per il suo studio di sviluppo e validazione. Con circa 6 milioni di pazienti statunitensi diagnosticati con AD da moderata a grave ogni anno e circa 760.000 in cerca di trattamento sistemico, il test mira a migliorare l'approccio attuale 'prove ed errori', in cui il 25% dei pazienti interrompe la terapia iniziale e il 50% mostra un carico di malattia persistente.

Assumendo una validazione positiva, Castle prevede di lanciare il test entro la fine del 2025.

Castle Biosciences (CSTL) ha proporcionado una actualización sobre su prueba de pipeline para pacientes con dermatitis atópica (AD) moderada a grave que buscan tratamiento sistémico. Los datos preliminares indican que la prueba podría identificar a los pacientes que probablemente logrará una respuesta excelente (reducción de la puntuación EASI del 90% o más) a terapias dirigidas en un plazo de tres meses.

La compañía ha inscrito a más de 1,100 pacientes en 39 sitios de estudio clínico para su estudio de desarrollo y validación. Con aproximadamente 6 millones de pacientes diagnosticados en EE. UU. con AD moderada a grave anualmente y aproximadamente 760,000 que buscan tratamiento sistémico, la prueba busca mejorar el enfoque actual de 'prueba y error', donde el 25% de los pacientes interrumpe la terapia inicial y el 50% presenta una carga de enfermedad persistente.

Suponiendo una validación exitosa, Castle espera lanzar la prueba a finales de 2025.

캐슬 바이오사이언스 (CSTL)는 전신 치료를 원하는 중등도에서 중증 아토피 피부염 (AD) 환자를 위한 파이프라인 테스트에 대한 업데이트를 제공했습니다. 초기 데이터에 따르면 이 테스트는 3개월 이내에 목표 치료에 대해 90% 이상의 EASI 점수 감소를 달성할 가능성이 높은 환자를 식별할 수 있을 것으로 보입니다.

회사는 개발 및 검증 연구를 위해 39개의 임상 연구 사이트에서 1,100명 이상의 환자를 등록했습니다. 매년 약 600만 명의 미국 환자가 중등도에서 중증 AD로 진단받고 있으며, 약 76만 명이 전신 치료를 원하고 있기 때문에 이 테스트는 25%의 환자가 초기 치료를 중단하고 50%가 지속적인 질병 부담을 보이는 현재의 '시험 및 오류' 접근 방식을 개선하는 것을 목표로 하고 있습니다.

성공적인 검증이 이루어진다고 가정할 때, 캐슬은 2025년 말까지 테스트를 출시할 계획입니다.

Castle Biosciences (CSTL) a fourni une mise à jour sur son test de pipeline pour les patients atteints de dermatite atopique (AD) modérée à sévère cherchant un traitement systémique. Les données préliminaires montrent que le test pourrait identifier les patients susceptibles d'obtenir une super réponse (réduction de 90 % ou plus du score EASI) à des thérapies ciblées dans un délai de trois mois.

L'entreprise a inscrit plus de 1 100 patients dans 39 sites d'études cliniques pour son étude de développement et de validation. Avec environ 6 millions de patients diagnostiqués aux États-Unis avec une AD modérée à sévère chaque année, et environ 760 000 cherchant un traitement systémique, le test vise à améliorer l'approche actuelle de 'preuve et erreur', où 25 % des patients interrompent la thérapie initiale et 50 % présentent un fardeau de maladie persistant.

En supposant une validation réussie, Castle prévoit de lancer le test d'ici la fin de 2025.

Castle Biosciences (CSTL) hat ein Update zu seinem Pipeline-Test für Patienten mit mittelschwerer bis schwerer atopischer Dermatitis (AD) bereitgestellt, die eine systemische Behandlung suchen. Vorläufige Daten zeigen, dass der Test Patienten identifizieren könnte, die mit großer Wahrscheinlichkeit innerhalb von drei Monaten eine Superantwort (eine Reduktion des EASI-Scores um 90% oder mehr) auf zielgerichtete Therapien erzielen.

Das Unternehmen hat über 1.100 Patienten an 39 klinischen Studienstandorten für seine Entwicklungs- und Validierungsstudie rekrutiert. Mit geschätzten 6 Millionen in den USA jährlich diagnostizierten Patienten mit mittelschwerer bis schwerer AD und etwa 760.000, die eine systemische Behandlung suchen, zielt der Test darauf ab, den aktuellen 'Test-und-Fehler'-Ansatz zu verbessern, bei dem 25% der Patienten die anfängliche Therapie abbrechen und 50% eine anhaltende Krankheitslast aufweisen.

Bei erfolgreicher Validierung erwartet Castle, den Test bis Ende 2025 auf den Markt zu bringen.

Positive
  • Preliminary data shows potential to identify patients likely to achieve super response to targeted therapies
  • Large market opportunity with 760,000 potential patients seeking systemic treatment annually
  • Strong enrollment with over 1,100 patients across 39 clinical sites
Negative
  • Product launch not expected until end of 2025
  • Test still requires successful validation
  • Reimbursement pathway not yet determined

Insights

<p>The development of Castle Biosciences' gene expression profile test for atopic dermatitis represents a meaningful advancement in personalized medicine, targeting a significant market of <b>over 6 million U.S. patients</b> with moderate-to-severe AD. The preliminary data showing potential identification of super responders (EASI90) is particularly noteworthy, as it exceeds the traditional EASI75 benchmark used in clinical trials.</p><p>The <b>760,000 patients seeking systemic treatment</b> represent a substantial addressable market. With current treatment discontinuation rates at <percent>25%</percent> and persistent disease burden in <percent>50%</percent> of continuing patients, a predictive test could significantly improve treatment outcomes and reduce healthcare costs. The robust validation study involving <b>1,100 patients across 39 sites</b> adds credibility to the development process.</p><p>However, the <b>2025 launch timeline</b> indicates a relatively long pathway to commercialization and reimbursement strategies remain undefined. This extended timeline could impact near-term revenue potential and market positioning.</p>

<p>The atopic dermatitis diagnostic market represents a significant commercial opportunity. The current inefficient trial-and-error approach to systemic therapy creates a clear value proposition for Castle's test. Successful commercialization could position CSTL to capture a meaningful share of the diagnostic market in the <b>$16 billion global atopic dermatitis therapeutics space</b>.</p><p>The test's focus on super responders (EASI90) aligns with emerging market trends toward precision medicine and could provide a competitive advantage. However, market penetration will heavily depend on physician adoption, payer coverage and competition from existing or emerging diagnostic solutions. The 2025 launch timeline suggests cautious near-term market expectations are warranted.</p>

Assuming successful validation, the Company currently expects to launch the pipeline test by the end of 2025

FRIENDSWOOD, Texas--(BUSINESS WIRE)-- 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

Investor Contact:

Camilla Zuckero

czuckero@castlebiosciences.com

Media Contact:

Allison Marshall

amarshall@castlebiosciences.com

Source: Castle Biosciences Inc.

FAQ

When will Castle Biosciences (CSTL) launch its atopic dermatitis gene expression test?

Castle Biosciences expects to launch its atopic dermatitis gene expression test by the end of 2025, pending successful validation.

How many patients has CSTL enrolled in its atopic dermatitis test validation study?

As of September 30, 2024, Castle Biosciences has enrolled more than 1,100 patients across 39 active clinical study sites.

What is the market size for CSTL's atopic dermatitis test?

The market includes over 6 million U.S. patients diagnosed with moderate-to-severe atopic dermatitis annually, with approximately 760,000 seeking systemic treatment.

What improvement does CSTL's new test offer over current atopic dermatitis treatment methods?

The test aims to improve the current 'trial-and-error' approach by identifying patients more likely to achieve a super response (90% or greater reduction in EASI score) to specific therapies within three months.

What percentage of atopic dermatitis patients currently discontinue initial systemic therapy?

According to the press release, approximately 25% of patients discontinue their initial systemic therapy under the current treatment approach.

Castle Biosciences, Inc.

NASDAQ:CSTL

CSTL Rankings

CSTL Latest News

CSTL Stock Data

761.24M
27.03M
3.22%
94.52%
6.1%
Diagnostics & Research
Services-medical Laboratories
Link
United States of America
FRIENDSWOOD