Aclaris Therapeutics Receives FDA Approval to Begin Clinical Trial of ATI-052, a Novel Bispecific Antibody
Wednesday, April 23, 2025
Aclaris Therapeutics has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application, allowing the company to proceed with clinical testing of ATI-052.
ATI-052 is engineered to simultaneously block thymic stromal lymphopoietin (TSLP) and interleukin-4 receptor (IL-4R). This dual mechanism disrupts a central inflammatory pathway by inhibiting both upstream and downstream signalling involving IL-4 and IL-13. The antibody also features enhanced binding to the neonatal Fc receptor, which may improve its stability and prolong its effects in the body.
ATI-052 builds on earlier research involving bosakitug (ATI-045), another anti-TSLP antibody under development by Aclaris. Unlike ATI-045, ATI-052 offers broader activity due to its bispecific nature. It holds promise for the treatment of various atopic, respiratory, and immune-mediated conditions.
This investigational therapy is a bispecific monoclonal antibody designed to target immuno-inflammatory diseases.
The Phase 1a/1b clinical trial, scheduled to begin in the second quarter of 2025, will assess the safety and tolerability of ATI-052 through single and multiple ascending doses. The study will also include a proof-of-concept segment for an unspecified indication.
The IND approval represents a key step forward in Aclaris’ pipeline, reflecting the company’s continued focus on innovative therapies for immune-related diseases.
Aclaris holds global rights to ATI-052, with the exception of Greater China.
Source: aclaristx.com
