WAYNE, PA — Aclaris Therapeutics, Inc. (NASDAQ: ACRS) has announced significant findings about ATI-2138, a novel investigational drug that acts as a covalent inhibitor of two key immune signaling kinases, ITK and JAK3. Details about ATI-2138’s unique mechanism of action and its progress in preclinical and clinical evaluations were published in The Journal of Pharmacology and Experimental Therapeutics. This development positions the molecule as a potential breakthrough in the treatment of autoimmune and inflammatory diseases.
ATI-2138 exhibits the ability to selectively and potently block interleukin-2-inducible T cell kinase (ITK) and Janus kinase 3 (JAK3), playing a key role in modulating T cell activity involved in chronic inflammatory conditions such as atopic dermatitis, alopecia areata, and vitiligo. According to Dr. Joseph Monahan, Chief Scientific Officer of Aclaris Therapeutics, “This publication provides important clinical and non-clinical evidence of the potential for ATI-2138 to be a best-in-class inhibitor of key signal transduction kinases as a result of its unique mechanism of action.”
Preclinical studies demonstrated ATI-2138’s efficacy in suppressing T cell subtypes (Th1, Th2, and Th17) linked to autoimmune and allergic diseases. The publication disclosed key findings, including ATI-2138’s exceptional target selectivity and potency across cellular systems. Compared to ritlecitinib, another dual-kinase inhibitor, ATI-2138 displayed superior inhibition of ITK-mediated T cell receptor signaling. Additionally, results show efficacy in rodent models of chronic inflammation, translating laboratory findings into real-world potential for disease modulation.
Phase 1 clinical trials further validated ATI-2138’s promise, with the drug being generally well-tolerated in healthy participants during single and multiple ascending dose studies. Across all dosing levels, there were no clinically significant adverse events, and biomarker assessments confirmed the drug’s activity on ITK and JAK3 targets.
ATI-2138’s dual inhibition capability offers hope for addressing diseases driven by T cell function and cytokine signaling, such as autoimmune conditions and chronic inflammatory disorders. By focusing on ITK, a regulator of T cell activity, and JAK3, a key player in signaling through the IL-2 receptor pathway, ATI-2138 brings a novel therapeutic mechanism to the forefront of inflammatory disease treatment strategies.
The ongoing Phase 2a clinical trial of ATI-2138 in atopic dermatitis marks a critical step in advancing this molecule through the development pipeline. Dr. Monahan emphasized the opportunity for ATI-2138 to impact a broad range of disorders, stating, “Data generated to date support our ongoing clinical efforts, including our continued exploration of ATI-2138 for potential broad applications.”
This announcement spotlights Aclaris Therapeutics’ efforts to innovate in immune modulation and highlights the progress of ATI-2138 as a promising candidate in the field of inflammatory diseases. With continued clinical evaluation underway, ATI-2138 holds the potential to reshape treatment options and improve outcomes for patients worldwide.
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