Aclaris Therapeutics Announces First Patient Dosed in Phase 2a Clinical Trial of ATI-2138, an Investigational Oral Covalent ITK/JAK3 Inhibitor for the Treatment of Moderate to Severe Atopic Dermatitis
Aclaris Therapeutics (NASDAQ: ACRS) has announced the dosing of the first patient in its Phase 2a clinical trial of ATI-2138, an investigational oral covalent inhibitor of ITK and JAK3, for treating moderate to severe atopic dermatitis. The open-label study aims to evaluate the safety, tolerability, pharmacokinetics, efficacy, and pharmacodynamics of ATI-2138 over a 12-week period.
The trial plans to enroll approximately 15 subjects in the United States, with primary endpoints focusing on safety-related parameters. Secondary endpoints include EASI response measures, vIGA response, and BSA response. Aclaris expects to release topline data from this trial in the first half of 2025.
Aclaris Therapeutics (NASDAQ: ACRS) ha annunciato la somministrazione del primo paziente nel suo studio clinico di Fase 2a di ATI-2138, un inibitore covalente orale sperimentale di ITK e JAK3, per il trattamento della dermatite atopica da moderata a grave. Lo studio open-label mira a valutare la sicurezza, tollerabilità, farmacocinetica, efficacia e farmacodinamica di ATI-2138 nell'arco di un periodo di 12 settimane.
Il trial prevede di arruolare circa 15 soggetti negli Stati Uniti, con obiettivi primari focalizzati su parametri legati alla sicurezza. Gli obiettivi secondari includono misure di risposta EASI, risposta vIGA e risposta BSA. Aclaris prevede di rilasciare dati preliminari da questo trial nella prima metà del 2025.
Aclaris Therapeutics (NASDAQ: ACRS) ha anunciado la dosificación del primer paciente en su ensayo clínico de Fase 2a de ATI-2138, un inibidor covalente oral en investigación de ITK y JAK3, para el tratamiento de dermatitis atópica moderada a severa. El estudio abierto tiene como objetivo evaluar la seguridad, tolerabilidad, farmacocinética, eficacia y farmacodinámica de ATI-2138 durante un periodo de 12 semanas.
El ensayo planea inscribir aproximadamente 15 sujetos en los Estados Unidos, con puntos finales primarios centrados en parámetros relacionados con la seguridad. Los puntos finales secundarios incluyen medidas de respuesta EASI, respuesta vIGA y respuesta BSA. Aclaris espera publicar los datos preliminares de este ensayo en la primera mitad de 2025.
Aclaris Therapeutics (NASDAQ: ACRS)는 중증의 아토피 피부염 치료를 위한 ITK 및 JAK3의 경구용 공유 결합 억제제인 ATI-2138의 2상 임상 시험에서 첫 번째 환자의 용량 투여를 발표했습니다. 이 공개 연구는 12주 동안 ATI-2138의 안전성, 내약성, 약물 동태학, 효능 및 약리학적 작용을 평가하는 것을 목표로 하고 있습니다.
이 시험은 미국 내 약 15명의 피험자를 모집할 예정이며, 주요 종결점은 안전성 관련 매개변수에 초점을 맞추고 있습니다. 2차 종결점에는 EASI 반응 측정, vIGA 반응 및 BSA 반응이 포함됩니다. Aclaris는 이 시험의 초기 데이터를 2025년 상반기에 발표할 계획입니다.
Aclaris Therapeutics (NASDAQ: ACRS) a annoncé la dosification du premier patient dans son essai clinique de Phase 2a de l'ATI-2138, un inhibiteur covalent oral expérimental de l'ITK et du JAK3, pour le traitement de la dermatite atopique modérée à sévère. L'étude en ouvert vise à évaluer la sûreté, tolérance, pharmacocinétique, efficacité et pharmacodynamique de l'ATI-2138 sur une période de 12 semaines.
L'essai prévoit de recruter environ 15 sujets aux États-Unis, avec des points d'évaluation principaux axés sur des paramètres liés à la sécurité. Les points d'évaluation secondaires incluent les mesures de réponse EASI, la réponse vIGA et la réponse BSA. Aclaris s'attend à publier les données préliminaires de cet essai dans la première moitié de 2025.
Aclaris Therapeutics (NASDAQ: ACRS) hat die Dosierung des ersten Patienten in seiner Phase 2a-Studie zu ATI-2138, einem experimentellen oralen kovalenten Inhibitor von ITK und JAK3 zur Behandlung von moderater bis schwerer atopischer Dermatitis, bekannt gegeben. Die offene Studie zielt darauf ab, die Sicherheit, Verträglichkeit, Pharmakokinetik, Wirksamkeit und Pharmakodynamik von ATI-2138 über einen Zeitraum von 12 Wochen zu bewerten.
Die Studie plant die Einschließung von etwa 15 Probanden in den Vereinigten Staaten, wobei die primären Endpunkte auf sicherheitsbezogene Parameter fokussiert sind. Sekundäre Endpunkte umfassen EASI-Reaktionsmaße, vIGA-Reaktion und BSA-Reaktion. Aclaris erwartet, die Topline-Daten dieser Studie in der ersten Hälfte von 2025 zu veröffentlichen.
- Initiation of Phase 2a clinical trial for ATI-2138 in atopic dermatitis
- Unique dual inhibitor mechanism targeting both ITK and JAK3
- Potential new treatment option for moderate to severe atopic dermatitis
- Small sample size of approximately 15 subjects may limit data robustness
- Topline data not expected until first half of 2025, indicating a long wait for results
Insights
The initiation of the Phase 2a trial for ATI-2138 in atopic dermatitis (AD) is a significant step for Aclaris Therapeutics. As a dual inhibitor of ITK and JAK3, ATI-2138 presents a novel mechanism of action in the AD treatment landscape. This approach could potentially offer improved efficacy over existing therapies.
The trial's design, with 15 subjects over 12 weeks, is appropriate for an early-stage study. The focus on safety as the primary endpoint is important for this new compound. The inclusion of EASI and vIGA scores as secondary endpoints aligns with standard efficacy measures in AD trials. However, the open-label design may limit the interpretation of efficacy results.
While promising, it's important to note that many compounds fail in Phase 2. Investors should monitor for any safety signals and efficacy trends in the topline data expected in H1 2025.
This Phase 2a trial initiation is a positive development for Aclaris, potentially de-risking their pipeline. However, the small trial size and early-stage nature mean it's unlikely to significantly impact near-term financials.
The atopic dermatitis market is highly competitive, with established players like Sanofi/Regeneron's Dupixent. For ATI-2138 to be commercially viable, it will need to demonstrate superior efficacy or safety profiles in later-stage trials.
Investors should consider Aclaris' cash runway and burn rate as they progress this and other pipeline candidates. With results expected in H1 2025, any potential revenue impact is still years away. The company's ability to fund development through to potential approval will be important for long-term value creation.
WAYNE, Pa., Sept. 17, 2024 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced that the first patient has been dosed in Aclaris' Phase 2a clinical trial of ATI-2138, an investigational oral covalent inhibitor of interleukin-2-inducible T cell kinase (ITK) and Janus kinase (JAK) 3, for the treatment of moderate to severe atopic dermatitis (AD).
"We are thrilled to have dosed the first patient in this clinical trial, marking an important milestone for our ITK inhibitor programs," said Dr. Neal Walker, Interim President & CEO and Chair of the Board of Directors of Aclaris. "ATI-2138 has a unique mechanism of action as a dual inhibitor of both ITK and JAK3. We look forward to evaluating the potential of ATI-2138 as a treatment option for patients with atopic dermatitis."
The Phase 2a trial is an open-label study to investigate the safety, tolerability, pharmacokinetics, efficacy, and pharmacodynamics of ATI-2138 administered over 12 weeks in patients with moderate to severe atopic dermatitis. Aclaris' planned enrollment for this trial is approximately 15 subjects, and the trial will be conducted in the United States. The primary endpoints are safety-related parameters. Secondary endpoints include Eczema Area and Severity Index (EASI) response measures, including EASI-50, EASI-75, and EASI-90, Validated Investigator Global Assessment (vIGA) response, body surface area (BSA) response and other pertinent efficacy related measures. Aclaris expects topline data from this trial in the first half of 2025.
About ATI-2138
ATI-2138 is an investigational oral covalent inhibitor of ITK, and JAK3 for the potential treatment of T cell-mediated autoimmune diseases. The ITK/JAK3 compound interrupts T cell signaling through the combined inhibition of ITK/JAK3 pathways in lymphocytes. Aclaris is developing ATI-2138 as a potential treatment for T cell-mediated autoimmune diseases.
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com.
Cautionary Note Regarding Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “anticipate,” “believe,” “expect,” “intend,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on Aclaris’ current beliefs and expectations. These forward-looking statements include expectations regarding ATI-2138 as a potential treatment for moderate to severe atopic dermatitis and other T cell-mediated diseases, and the clinical development of ATI-2138, including the timing for topline data. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris’ reliance on third parties over which it may not always have full control, Aclaris’ ability to enter into strategic partnerships on commercially reasonable terms, the uncertainty regarding the macroeconomic environment and other risks and uncertainties that are described in the Risk Factors section of Aclaris’ Annual Report on Form 10-K for the year ended December 31, 2023, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the “SEC Filings” page of the “Investors” section of Aclaris’ website at www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
Aclaris Therapeutics Contact:
investors@aclaristx.com
FAQ
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