Aclaris Begins Dosing in Phase 2a Trial of ATI-2138 for Atopic Dermatitis

On September 17, 2024, Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a biopharmaceutical company in the clinical stage, announced the commencement of its Phase 2a clinical trial for ATI-2138. This investigational drug is an oral covalent inhibitor targeting interleukin-2-inducible T cell kinase (ITK) and Janus kinase (JAK) 3, and is being tested for its efficacy in treating moderate to severe atopic dermatitis (AD).

Dr. Neal Walker, Interim President & CEO and Chair of the Board of Directors at Aclaris, expressed enthusiasm about this development, stating that dosing the first patient is a significant milestone for their ITK inhibitor programs. He highlighted the unique mechanism of ATI-2138 as a dual inhibitor of ITK and JAK3 and the potential this drug holds as a new treatment option for patients suffering from atopic dermatitis.

The Phase 2a trial is designed as an open-label study to evaluate the safety, tolerability, pharmacokinetics, efficacy, and pharmacodynamics of ATI-2138 in patients over a 12-week period. The trial aims to enroll around 15 subjects and will be conducted across the United States. The primary focus will be on safety parameters, while secondary endpoints will measure efficacy using the Eczema Area and Severity Index (EASI) response, including EASI-50, EASI-75, and EASI-90, as well as the Validated Investigator Global Assessment (vIGA) response, body surface area (BSA) response, and other relevant efficacy metrics. Aclaris anticipates releasing topline data from this trial in the first half of 2025.

ATI-2138 functions as an investigational oral covalent inhibitor of both ITK and JAK3, positioned to potentially treat T cell-mediated autoimmune diseases. The compound works by interrupting T cell signaling through the dual inhibition of ITK and JAK3 pathways in lymphocytes. This dual inhibition mechanism is being explored as a novel approach for treating various autoimmune conditions mediated by T cells.

Aclaris Therapeutics, Inc. is focused on developing new drug candidates aimed at treating immuno-inflammatory diseases, especially for patients who do not have satisfactory treatment options available. The company boasts a diverse pipeline of drug candidates, supported by a strong research and development framework that emphasizes protein kinase regulation.

This announcement reflects Aclaris’ ongoing commitment to advancing its portfolio of investigational medicines and addressing unmet medical needs in the realm of immuno-inflammatory diseases. The progress of ATI-2138 through the clinical trial stages marks a significant stride toward offering new therapeutic options for conditions like atopic dermatitis, which affect a substantial number of patients worldwide.