Aclaris Therapeutics Gets FDA IND Clearance for ATI-052, Advancing Novel Antibody

Aclaris Therapeutics, Inc., a biopharmaceutical company focused on developing innovative treatments for immuno-inflammatory diseases, has received approval from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application. This approval allows the company to commence a Phase 1a/1b clinical trial for ATI-052, a promising bispecific monoclonal antibody targeting TSLP and IL-4R. The trial is expected to begin in the second quarter of 2025.

Aclaris has identified therapeutic innovation as a key component of its mission, with a particular interest in the development of bispecific antibodies, which are seen as a significant advancement in the field of immunotherapy. Dr. Hugh Davis, the President and Chief Operating Officer of Aclaris, emphasized the importance of this therapeutic approach, stating that bispecific antibodies could significantly enhance the treatment options available for various conditions.

The upcoming clinical trial will be randomized, blinded, and placebo-controlled. It will examine both single and multiple ascending doses of ATI-052, followed by a proof-of-concept phase in an as-yet undisclosed indication. The aim is to evaluate the antibody’s safety and effectiveness in blocking the TSLP and IL-4R pathways, which play a central role in inflammatory responses.

Designed to bind simultaneously to two targets, bispecific antibodies like ATI-052 offer the potential for greater efficacy compared to traditional monoclonal antibodies. By inhibiting multiple signaling pathways, they could be relevant in treating a broad spectrum of immune-mediated diseases.

An IND application is a formal request to the FDA for authorization to start testing a new drug in humans. The application must include comprehensive data about the drug, its chemical makeup, results from preclinical studies, proposed clinical trial protocols, and details related to manufacturing and quality control processes. IND clearance is mandatory before any clinical trial can commence in the United States.

ATI-052 specifically targets the TSLP and IL-4 receptor, effectively blocking both the upstream TSLP signaling and the downstream IL-4R activation. By doing so, it inhibits IL-4 and IL-13 signaling pathways, thereby disrupting a crucial inflammatory process. This dual-action mechanism potentially makes ATI-052 a more effective treatment option by offering enhanced efficacy through the inhibition of both pathways.

Aclaris possesses the exclusive global rights to ATI-052, with the exception of the Greater China region. This investigational drug is part of a broader strategy to address unmet needs in treating atopic, immunologic, and respiratory diseases by employing novel therapeutic approaches.

Aclaris Therapeutics, Inc. is committed to advancing its pipeline of novel products aimed at addressing the needs of patients with limited treatment options for immuno-inflammatory diseases. The company’s research and development efforts are geared toward creating a diverse portfolio of new treatments, underscoring its role as an innovator in the biopharmaceutical industry.