WAYNE, PA — Aclaris Therapeutics, Inc. (NASDAQ: ACRS) said it has launched a placebo-controlled Phase 1b proof-of-concept trial of ATI-052, an experimental bispecific antibody aimed at treating atopic dermatitis, marking the latest advance in the company’s immunology pipeline.
The randomized, blinded trial will evaluate the safety and tolerability of ATI-052 in patients with moderate-to-severe atopic dermatitis, also known as eczema, while exploring early signs of clinical benefit. The study follows positive Phase 1a interim data that showed a favorable safety profile, extended drug exposure in the body, and dose-related biological activity, even at the lowest dose tested.
“We are experiencing strong momentum in the ATI-052 clinical development program,” said Dr. Jesse Hall, chief medical officer of Aclaris. He said the company expects to initiate a second Phase 1b proof-of-concept trial in asthma this quarter and plans to report top-line results from both studies in the second half of 2026.
The Phase 1b atopic dermatitis trial will enroll patients in a 3-to-1 ratio of ATI-052 to placebo. In addition to safety and tolerability, researchers will assess clinical efficacy using established measures such as the Eczema Area and Severity Index, Investigator Global Assessment response, and Peak Pruritus Numerical Rating Scale. The study will also track pharmacokinetic and pharmacodynamic markers, including analyses of lesional and non-lesional skin samples.
ATI-052 is a humanized bispecific antibody designed to simultaneously block thymic stromal lymphopoietin and the interleukin-4 receptor alpha. By targeting both pathways, the drug is intended to suppress inflammation at its source while also inhibiting key downstream signals involved in allergic and Th2-driven diseases.
Aclaris said ATI-052 is engineered to bind more tightly to the neonatal Fc receptor, extending its half-life compared with related antibodies. The drug uses the same TSLP-binding region as bosakitug, another Aclaris candidate, while incorporating design changes intended to enhance durability and potency.
Atopic dermatitis affects millions of patients worldwide and is often associated with intense itching, chronic skin inflammation, and reduced quality of life. While several biologic therapies are already approved, Aclaris is positioning ATI-052 as a potential best-in-class option with broader inflammatory control.
The company said it expects to begin the Phase 1b asthma trial in the first quarter of 2026. Aclaris holds exclusive worldwide rights to ATI-052, excluding Greater China, and said the program could ultimately support development across multiple atopic, immunologic, and respiratory diseases.
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