The U.S. Food and Drug Administration (FDA) has cleared Aclaris Therapeutics, Inc.’s Investigational New Drug (IND) application for a Phase 1a/1b clinical trial of ATI-052, a bispecific anti-Thymic Stromal Lymphopoietin (TSLP)/Interleukin-4 Receptor (IL-4R) monoclonal antibody being developed for immuno-inflammatory diseases.
The randomized, blinded, placebo-controlled, Phase 1a/1b clinical trial will evaluate single and multiple ascending doses of ATI-052 followed by a proof-of-concept part in an undisclosed indication. The Company expects to initiate the trial in the second quarter of 2025.
Bispecific antibodies are engineered to have two distinct binding domains that can bind to two targets simultaneously. “Developing bispecific antibodies for immuno-inflammatory disorders is of significant interest to Aclaris, and the clearance of the ATI-052 IND by the FDA is an important milestone in that regard,” says Dr. Hugh Davis, Aclaris’ President and Chief Operating Officer, in a news release.
