Aclaris Gets FDA Nod to Begin Phase 1a/1b Trial of ATI-052 Therapy

Aclaris Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, announced that the US Food and Drug Administration (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.

“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,” said Dr. Hugh Davis, Aclaris’ president and chief operating officer. “Key to our license agreement with Biosion, Inc. 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 by the FDA is an important milestone in that regard.”

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 portion 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. 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.

An IND application is a request submitted to the FDA seeking permission to test a new drug in humans. The application includes detailed information about the investigational drug, its composition, pharmacology and toxicology data from preclinical studies, proposed clinical trial protocols, and information on manufacturing and quality control. Organizations can initiate a clinical trial in the US only with IND clearance from the FDA.

ATI-052 is an investigational, potential best-in-class anti-TSLP/IL-4R bispecific monoclonal antibody being developed to treat certain immuno-inflammatory diseases. ATI-052 targets thymic stromal lymphopoietin (TSLP) and interleukin-4 receptor (IL-4R) that blocks both the upstream TSLP receptor signal transduction and downstream IL-4R activation which inhibits both IL-4 and IL-13 signalling, thereby inhibiting this central proinflammatory pathway and potentially offering enhanced efficacy through dual pathway inhibition. ATI-052 utilizes the same TSLP antigen-binding fragment (Fab) region as bosakitug (ATI-045), Aclaris’ investigational anti-TSLP monoclonal antibody, but is engineered to bind more tightly to the neonatal Fc receptor (FcRn), potentially extending its half-life. ATI-052 has the potential to treat a variety of atopic, immunologic and respiratory diseases. Aclaris has the exclusive worldwide rights to ATI-052, excluding Greater China.

Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel product candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options.

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