WAYNE, PA — Aclaris Therapeutics, Inc. (NASDAQ: ACRS) has announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for ATI-052, a bispecific monoclonal antibody targeting immuno-inflammatory diseases. The FDA clearance allows the company to proceed with a Phase 1a/1b clinical trial, anticipated to begin in the second quarter of 2025.
ATI-052 is designed to inhibit key proinflammatory pathways by targeting the TSLP ligand and IL-4 receptor. By leveraging dual binding domains, it aims to enhance efficacy compared to traditional monoclonal antibodies. The trial will include single and multiple ascending dose evaluations, followed by proof-of-concept testing in an undisclosed indication.
“Therapeutic innovation is at the core of the important work we do at Aclaris,” said Dr. Hugh Davis, President and COO of Aclaris. “The clearance of the ATI-052 IND by the FDA is an important milestone in our mission to develop groundbreaking immunotherapies.”
ATI-052 builds on Aclaris’ existing portfolio, incorporating advancements to extend its half-life and offer greater potential for addressing atopic, immunologic, and respiratory conditions. This marks a significant step in the company’s commitment to advancing treatments for complex inflammatory diseases while tapping into cutting-edge bispecific antibody technology.
With this FDA clearance, Aclaris continues to establish itself as a leader in the development of innovative therapies for unmet medical needs.
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