Aclaris Therapeutics announces results from Phase 1 MAD trial of ATI-2138

Aclaris Therapeutics announced positive results from ATI-2138-PKPD-102, a Phase 1 Multiple Ascending Dose, MAD, trial of the investigational compound ATI-2138. Preliminary data from the MAD trial demonstrated: that ATI-2138 was generally well tolerated at all doses tested in the trial; that ATI-2138 had dose proportional pharmacokinetics; and a dose-dependent inhibition of both ITK and JAK3 exploratory pharmacodynamic biomarkers, with near maximal inhibition achieved at the 30 mg total daily dose. Based on these results, Aclaris will progress this program into a Phase 2a proof of concept study in patients with ulcerative colitis, its previously announced intended first clinical development target, and anticipates initiation of the trial in early 2024. Aclaris is also exploring the potential of conducting a second proof of concept trial in an additional T cell-mediated autoimmune disease. “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,” stated Doug Manion, M.D., Aclaris’ Chief Executive Officer. “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.”