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Aclaris Therapeutics Initiates Phase 1a/1b Program for its Novel Bispecific Antibody ATI-052
- Potential Best-In-Class Bispecific Antibody ATI-052 Targets Both Thymic Stromal Lymphopoietin (TSLP) and Interleukin-4 Receptor (IL-4R) - WAYNE, Pa., June
About this update from Aclaris Therapeutics, Inc.
[{"type":"text","content":"- Potential Best-In-Class Bispecific Antibody ATI-052 Targets Both Thymic Stromal Lymphopoietin (TSLP) and Interleukin-4 Receptor (IL-4R) - WAYNE, Pa., June 23, 2025 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced that it has initiated a placebo-controlled Phase 1a/1b program for ATI-052, the Company’s potential best-in-class investigational bispecific anti-TSLP/IL-4R antibody. The program will consist of a Phase 1a single and multiple ascending dose (SAD/MAD) portion in healthy volunteers, followed by an expected Phase 1b proof of concept portion. “This is an important milestone in the development of ATI-052, our uniquely potent bispecific anti-TSLP/IL-4R antibody, for which we recently received IND clearance from the U.S. Food and Drug Administration,” said Dr. Jesse Hall, Chief Medical Officer of Aclaris. “This novel bispecific antibody was designed to exhibit high binding affinity to, and dual blockade of, both upstream and downstream targets to selectively inhibit central proinflammatory pathways involved in Th2-mediated inflammation and allergic diseases. We expect to complete the Phase 1a SAD/MAD portion by year-end 2025 and provide top line results in early 2026, followed by the top line results from the Phase 1b portion in the second half of 2026.” The randomized, blinded, placebo-controlled Phase 1a portion is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneously administered ATI-052 initially in healthy adults receiving single ascending doses (SAD) and multiple ascending doses (MAD). The Phase 1b proof-of-concept assessment in up to two undisclosed indications is expected to follow the Phase 1a SAD/MAD portion of the program. Bispecific antibodies are engineered to have two distinct binding domains that can bind to two targets simultaneously. This dual binding and pathway inhibition potentially enhances efficacy over traditional monoclonal antibodies, with broad applications for the potential treatment of many immune-modulated diseases. About ATI-052 ATI-052 is an investigational humanized anti-TSLP and anti-IL-4R bispecific antibody that exhibits high binding affinity to and dual blockade of both the upstream thymic...