Aclaris Therapeutics’ IND for ATI-052 candidate granted FDA clearance

Aclaris Therapeutics (ACRS) announced that the FDA has cleared its Investigational New Drug – IND – application for a Phase 1a/1b clinical trial of ATI-052, a potential best-in-class bispecific anti-TSLP/IL-4R monoclonal antibody. The Phase 1a/1b clinical trial will evaluate single and multiple ascending doses of ATI-052 followed by a proof-of-concept portion in an undisclosed indication. The company expects to initiate the trial in Q2. 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.