- Aclaris Therapeutics (ACRS, Financial) receives FDA clearance for ATI-052 IND application.
- Phase 1a/1b clinical trial to begin in Q2 2025 for novel bispecific antibody.
- Trial focuses on immunotherapy advancement with dual-targeting mechanism.
Aclaris Therapeutics, Inc. (ACRS), a clinical-stage biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ATI-052. This clearance allows Aclaris to commence a Phase 1a/1b clinical trial of the bispecific anti-TSLP/IL-4R monoclonal antibody, marking a significant milestone in the development of their immuno-inflammatory pipeline.
The upcoming trial is slated to begin in the second quarter of 2025 and will feature a randomized, blinded, placebo-controlled design. It aims to evaluate single and multiple ascending doses of ATI-052, followed by a proof-of-concept phase in an undisclosed indication. This study will assess the potential benefits of dual targeting both the TSLP ligand and IL-4 receptor, a strategy that may offer improved efficacy over traditional monoclonal antibodies.
ATI-052 was acquired through a strategic licensing agreement with Biosion and is engineered to exhibit high binding affinity, enabling a dual blockade of inflammatory pathways. The development of bispecific antibodies like ATI-052 is seen as a promising innovation in immunotherapy, with potential applications in treating a variety of atopic, immunologic, and respiratory diseases.
As part of the development process, the IND clearance is crucial as it signifies that Aclaris has met FDA requirements regarding the drug's chemical composition, manufacturing, and preclinical safety. While the specific indication for ATI-052's trial remains undisclosed, this advancement reflects Aclaris' commitment to progressing their therapeutic candidates through regulatory pathways and into clinical testing.
