ATI-2138 is being developed for the treatment of various T cell-mediated diseases. Credit: CI Photos/Shutterstock.com.

Aclaris Therapeutics has unveiled preliminary positive data from the Phase I multiple ascending dose (MAD) ATI-2138-PKPD-102 study evaluating the potential of ATI-2138 in treating various T cell-mediated diseases.

The study assessed the pharmacokinetics (PK), pharmacodynamics (PD), tolerability, and safety of the oral covalent ITK/JAK3 inhibitor ATI-2138 in healthy volunteers.

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A total of 60 healthy subjects were divided into six dosing cohorts with eight active and two placebo in each arm. They received 10mg to 80mg of ATI-2138 daily for a duration of two weeks.

At all the doses tested, ATI-2138 was generally well tolerated with no serious adverse events reported.

The study also demonstrated that ATI-2138 had a dose-proportional PK and a dose-dependent inhibition of both ITK and JAK3 exploratory PD biomarkers.

Maximal inhibition of the T cell receptor function and cytokine signalling was observed in subjects who received 30 mg total daily dose of ATI-2138.

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Based on these positive results, Aclaris plans to commence a Phase IIa proof of concept trial of ATI-2138 in patients with ulcerative colitis, early next year.

The company further plans to carry out a second proof of concept study in an additional T cell-mediated autoimmune disease.

Aclaris Therapeutics CEO Doug Manion said: “The advancement of ATI-2138 to the proof-of-concept stage of development marks yet another example of the strength of our world-class discovery group and the KINect platform.

“With so much unmet medical need remaining in immuno-inflammatory diseases such as ulcerative colitis, it is gratifying for all of us at Aclaris to progress the development of ATI-2138 for patients who remain underserved by the existing treatment options for the disease.

“Additionally, we look forward to the data from our two most advanced programmes of zunsemetinib (ATI-450) in rheumatoid arthritis and ATI-1777 in atopic dermatitis later this year.”