WAYNE, PA — Aclaris Therapeutics, Inc. (NASDAQ: ACRS) has launched a Phase 1a/1b clinical program to evaluate the safety and efficacy of ATI-052, an investigational bispecific anti-TSLP/IL-4R antibody that could offer a breakthrough in treating Th2-mediated inflammatory and allergic diseases.
This trial, a milestone in the development of ATI-052, will begin with a randomized, placebo-controlled Phase 1a study. Healthy adult participants will receive single and multiple ascending doses (SAD/MAD) of the antibody to assess safety, tolerability, pharmacokinetics, and pharmacodynamics. A subsequent Phase 1b segment will explore proof-of-concept efficacy in up to two undisclosed indications, with results anticipated later in 2026.
“This is an important milestone in the development of ATI-052, our uniquely potent bispecific anti-TSLP/IL-4R antibody, for which we recently received IND clearance from the U.S. Food and Drug Administration,” said Dr. Jesse Hall, Chief Medical Officer of Aclaris. “We expect to complete the Phase 1a SAD/MAD portion by year-end 2025 and provide top-line results in early 2026, followed by the top-line results from the Phase 1b portion in the second half of 2026.”
ATI-052’s design offers dual binding capabilities, targeting upstream thymic stromal lymphopoietin (TSLP) receptor signals and downstream interleukin-4 receptor (IL-4R) activity. This dual blockade has the potential to disrupt a central proinflammatory pathway responsible for multiple allergic and autoimmune conditions, providing a broader and potentially more effective treatment approach.
Bispecific antibodies like ATI-052 are engineered with two distinct binding domains, allowing them to simultaneously inhibit multiple molecular targets. This mechanism not only enhances efficacy but also extends its application across a wide range of immune-mediated diseases, including respiratory and dermatologic conditions.
With exclusive global development rights (excluding Greater China) and a focus on broad therapeutic potential, Aclaris Therapeutics aims to position ATI-052 as a leading treatment option in the management of chronic inflammatory and allergic diseases.
The initiation of this trial spotlights Aclaris’ eforts to advance innovative therapies and address unmet medical needs in immune-modulated conditions.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.