The trial aims to assess the safety, tolerability, pharmacokinetics, and efficacy of ATI-2138 in atopic dermatitis patients. Credit: Evgeniia Primavera / Shutterstock.

Aclaris Therapeutics has dosed the first subject in the Phase IIa clinical trial of ATI-2138 to treat moderate to severe atopic dermatitis (AD).

The open-label trial aims to assess the safety, tolerability, pharmacokinetics, and efficacy of ATI-2138 in AD patients over 12 weeks.

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Being conducted in the US, the trial plans to enrol approximately 15 subjects.

Its primary endpoints focus on safety parameters while the secondary endpoints measure efficacy through Eczema Area and Severity Index (EASI) responses, including EASI-50; EASI-75; and EASI-90, as well as Validated Investigator Global Assessment (vIGA) responses; body surface area (BSA) responses; and other relevant measures.

Topline data from this trial is anticipated in the first half of next year.

ATI-2138 is an investigational oral covalent interleukin-2-inducible T-cell kinase (ITK) and Janus kinase (JAK) 3 inhibitor.

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The asset is being developed as a potential treatment for T-cell-mediated autoimmune diseases by disrupting T-cell signalling through the inhibition of ITK/JAK3 pathways in lymphocytes.

Aclaris Therapeutics is dedicated to creating new treatments for patients with immuno-inflammatory diseases lacking adequate treatment options.

The company’s pipeline includes a range of novel drug candidates, supported by a research and development platform focused on protein kinase regulation.

Aclaris Therapeutics interim president and CEO Dr Neal Walker said: “We are thrilled to have dosed the first patient in this clinical trial, marking an important milestone for our ITK inhibitor programmes.

“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.”

In October 2023, the company concluded the enrolment of 250 patients in the Phase IIb ATI-1777-AD-202 study of ATI-1777 to treat mild to severe AD.