Aclaris Reports Positive Phase 1 MAD Trial Results Of ATI-2138; To Progress To Phase 2a Trials

(RTTNews) - Aclaris Therapeutics Inc. (ACRS), a clinical-stage biopharmaceutical company, announced Monday positive results from ATI-2138-PKPD-102, a Phase 1 Multiple Ascending Dose or MAD trial of the investigational compound ATI-2138.

Based on the results, the company plans to progress this program into a Phase 2a proof of concept study in patients with ulcerative colitis, its previously announced intended first clinical development target. The initiation of the trial is expected to be in early 2024.

ATI-2138 is an investigational oral covalent ITK/JAK3 inhibitor that is being developed as a potential therapeutic option across a variety of T cell-mediated diseases.

ATI-2138-PKPD-102 was a two-week Phase 1 MAD trial to investigate the safety, tolerability, pharmacokinetics or PK and pharmacodynamic or PD of ATI-2138 in healthy volunteers.

In the trial, preliminary data showed that ATI-2138 was generally well tolerated at all doses tested in the trial; that ATI-2138 had dose proportional PK; and a dose-dependent inhibition of both ITK and JAK3 exploratory PD biomarkers, with near maximal inhibition achieved at the 30 mg total daily dose.

Aclaris further said it is exploring the potential of conducting a second proof of concept trial in an additional T cell-mediated autoimmune disease.

Doug Manion, Aclaris' Chief Executive Officer, said, "The advancement of ATI-2138 to proof-of-concept stage of development marks yet another example of the strength of our world class discovery group and the KINect platform. It is a rarity for a biotech company of our size to be armed with a productive discovery engine and expertise that rivals larger pharmaceutical companies."

Manion added that the company looks forward to the data from two most advanced programs, such as zunsemetinib (ATI-450) in rheumatoid arthritis and ATI-1777 in atopic dermatitis, expected later this year.

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