Aclaris Therapeutics (NASDAQ:ACRS) announced that the FDA has cleared its Investigational New Drug (IND) application for a Phase 1a/1b trial of ATI-052—expected to launch in Q2 of this year.
According to Aclaris, the trial will evaluate single and multiple doses of ATI-052, a potential best-in-class bispecific anti-TSLP/IL-4R monoclonal antibody. A proof-of-concept portion in an undisclosed indication will follow the trial.
In a statement, Dr. Hugh Davis, president and COO of Aclaris, said, “Therapeutic innovation is at the core of the important work we do at Aclaris, and bispecific antibodies represent a groundbreaking innovation in immunotherapy that we believe will evolve the therapeutic armamentarium in a variety of settings.”
He added, “Key to our licensing agreement with Biosion were the rights to ATI-052, a potential best-in-class investigational bispecific antibody that exhibits a high binding affinity to, and dual blockade of, both the TSLP ligand and the IL-4 receptor, and as such inhibits a key central proinflammatory pathway. Developing bispecific antibodies for immuno-inflammatory disorders is of significant interest to Aclaris, and the clearance of the ATI-052 IND is an important milestone in that regard.”
