Aclaris Therapeutics has commenced a Phase IIa clinical trial to investigate ATI-2138 as a potential treatment for moderate to severe atopic dermatitis (AD). The first subject has been dosed in this open-label study, which aims to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ATI-2138 over a 12-week treatment period.
Trial Design and Endpoints
The Phase IIa trial, conducted in the US, plans to enroll approximately 15 patients with atopic dermatitis. The primary endpoints of the study will focus on assessing the safety profile of ATI-2138. Secondary endpoints will measure efficacy through various assessments, including Eczema Area and Severity Index (EASI) responses (EASI-50, EASI-75, and EASI-90), Validated Investigator Global Assessment (vIGA) responses, and body surface area (BSA) responses.
ATI-2138: A Novel ITK/JAK3 Inhibitor
ATI-2138 is an investigational oral covalent inhibitor targeting both interleukin-2-inducible T-cell kinase (ITK) and Janus kinase (JAK) 3. This dual inhibition mechanism is designed to disrupt T-cell signaling, which is implicated in the pathogenesis of T-cell-mediated autoimmune diseases. By inhibiting ITK and JAK3 pathways in lymphocytes, ATI-2138 aims to modulate the immune response and reduce inflammation associated with atopic dermatitis.
Aclaris's Perspective
Dr. Neal Walker, interim president and CEO of Aclaris Therapeutics, expressed enthusiasm for the trial's initiation, stating, "We are thrilled to have dosed the first patient in this clinical trial, marking an important milestone for our ITK inhibitor programs. 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."
Anticipated Timeline
Aclaris Therapeutics anticipates topline data from this Phase IIa trial to be available in the first half of next year. The results will provide valuable insights into the potential of ATI-2138 as a novel therapeutic intervention for atopic dermatitis, a condition with significant unmet medical need.
