Aclaris Therapeutics’ Novel ITK/JAK3 Inhibitor ATI-2138 Demonstrates Rapid and Sustained Hair Regrowth in Validated Murine Model of Alopecia Areata (AA)

Core Insights - Aclaris Therapeutics announced positive preclinical results for its ITK/JAK3 inhibitor ATI-2138, showing significant hair regrowth in a murine model of severe alopecia areata [1][2][3] Group 1: Drug Mechanism and Efficacy - ATI-2138 is a potent and selective dual inhibitor of ITK and JAK3, effectively downregulating various inflammatory markers and reducing itch, making it suitable for treating immuno-inflammatory diseases [2][6] - In a murine model, mice treated with 300 ppm ATI-2138 showed a mean hair regrowth of 37% at week 2 and 87% at week 4, compared to ritlecitinib's 25% and 48% respectively [3] - By week 6, the mean hair regrowth for ATI-2138 reached 93%, significantly outperforming ritlecitinib, which achieved 78% [3] Group 2: Future Development Plans - Aclaris plans to initiate a Phase 2b trial for ATI-2138 in the first half of 2026, exploring its potential in treating various inflammatory and autoimmune diseases, including alopecias [5][6] - The company is assessing additional indications for ATI-2138, leveraging its unique pharmacological profile to address unmet medical needs in immuno-inflammatory conditions [5][6] Group 3: Company Overview - Aclaris Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapies for patients with immuno-inflammatory diseases lacking satisfactory treatment options [7] - The company has a robust R&D pipeline aimed at addressing various inflammatory diseases, supported by preclinical and clinical data demonstrating the efficacy of its product candidates [7]