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Aclaris Therapeutics Initiates Phase 1b Proof-of-Concept Trial in Atopic Dermatitis (AD) with Its Novel Bispecific Antibody ATI-052

WAYNE, Pa., Jan. 12, 2026 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing

articleAclaris Therapeutics, Inc.January 12, 20264/company/aclaris-therapeutics-inc/news/aclaris-therapeutics-initiates-phase-1b-proof-concept-trial-atopic-dermatitis-ad-its
Aclaris Therapeutics Initiates Phase 1b Proof-of-Concept Trial in Atopic Dermatitis (AD) with Its Novel Bispecific Antibody ATI-052

About this update from Aclaris Therapeutics, Inc.

[{"type":"text","content":"WAYNE, Pa., Jan. 12, 2026 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced that it has initiated a placebo-controlled Phase 1b proof-of-concept (POC) trial in atopic dermatitis (AD) for ATI-052, the Company’s potential best-in-class investigational bispecific anti-TSLP/IL-4Rα antibody. “We are experiencing strong momentum in the ATI-052 clinical development program including the recent positive Phase 1a interim results which demonstrated a strong safety and tolerability profile, extended pharmacokinetics, and concentration-dependent pharmacodynamics even at the lowest dose,” said Dr. Jesse Hall, Chief Medical Officer of Aclaris. “Further to this, we are excited to announce the initiation of the first POC Phase 1b trial in people living with atopic dermatitis. We expect to initiate the second Phase 1b POC trial in asthma this quarter as well. We intend to provide top line results from both trials in the second half of the year.” This randomized (3:1), blinded, placebo-controlled Phase 1b POC trial will evaluate the safety and tolerability of ATI-052 compared to placebo in patients with moderate-to-severe AD. Other endpoints that will be assessed include AD clinical efficacy assessments (Eczema Area and Severity Index (EASI), validated Investigator Global Assessment (IGA) response, and Peak Pruritus Numerical Rating Scale (PP-NRS)), pharmacokinetic parameters, and pharmacodynamic endpoints measured by assays including lesional and non-lesional skin tape strips. Aclaris also expects to initiate a Phase 1b POC trial in asthma in the first quarter of 2026. Top line results from both POC trials are expected in the second half of 2026. About ATI-052 ATI-052 is an investigational humanized anti-TSLP and anti-IL-4Rα bispecific antibody that simultaneously inhibits thymic stromal lymphopoietin (TSLP) and interleukin-4 receptor (IL-4Ra) with high affinity and potency. By targeting TSLP, which sits at the top of the inflammatory cascade, it inhibits a broad range of inflammation; by targeting IL-4Rα, it blocks both downstream IL-4 and IL-13, which are key cytokines involved in Th2-mediated inflammation and allergic diseases. ATI-052 exhibits potential best-in-class potency and utilizes the...

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