Aclaris Therapeutics Initiates Phase 2a Trial for ATI-2138 in Moderate to Severe Atopic Dermatitis

Aclaris Therapeutics has begun its Phase 2a clinical trial for ATI-2138, an investigational drug for atopic dermatitis. The trial aims to assess safety and efficacy, with a target enrollment of 15 subjects and topline data expected by mid-2025. ATI-2138 is a dual inhibitor of ITK and JAK3, targeting T cell-mediated autoimmune diseases.

As the global prevalence of atopic dermatitis (AD) continues to rise, the quest for effective treatments remains a pressing challenge [1]. Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company specializing in immuno-inflammatory diseases, has taken a significant step forward in this endeavor by announcing the initiation of a Phase 2a clinical trial for ATI-2138, an investigational oral covalent inhibitor of interleukin-2-inducible T cell kinase (ITK) and Janus kinase (JAK) 3 [1].

The trial, which is currently enrolling approximately 15 patients with moderate to severe AD in the United States, aims to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ATI-2138 over a 12-week period [1]. The primary endpoints of the study focus on safety-related parameters, while secondary endpoints include measuring changes in the Eczema Area and Severity Index (EASI), the Validated Investigator Global Assessment (vIGA), and body surface area (BSA) [1].

ATI-2138's unique mechanism of action lies in its dual inhibition of both ITK and JAK3 pathways, which are crucial for T cell signaling in lymphocytes [1]. By interrupting these pathways, ATI-2138 holds promise as a potential treatment option for patients with T cell-mediated autoimmune diseases, including AD [1].

Aclaris' decision to pursue ATI-2138 in AD builds on its extensive experience in the field of immuno-inflammatory diseases and its commitment to addressing the needs of patients who lack satisfactory treatment options [1]. The company's pipeline includes several other novel drug candidates designed to tackle various immuno-inflammatory diseases.

For more information on Aclaris Therapeutics and its clinical trials, please visit the company's website at https://www.aclaristx.com/.

References:
[1] Aclaris Therapeutics, Inc. Press Release. "Aclaris Therapeutics Announces First Patient Dosed in Phase 2a Clinical Trial of ATI-2138 for the Treatment of Atopic Dermatitis." GlobeNewswire, September 17, 2024. https://www.marketscreener.com/quote/stock/ACLARIS-THERAPEUTICS-INC-26123625/news/Aclaris-Therapeutics-Announces-First-Patient-Dosed-in-Phase-2a-Clinical-Trial-of-ATI-2138-an-Invest-47883773/