Aclaris Therapeutics Reports Positive Interim Results for ATI-052 Phase 1a Trial
WAYNE, Pa., January 06, 2026 (GLOBE NEWSWIRE) — Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing innovative therapies for immuno-inflammatory diseases, announced today promising interim results from its first-in-human Phase 1a trial of the anti-TSLP/IL-4Rα bispecific antibody, ATI-052. These findings highlight the drug’s safety, efficacy, and potential for use in a variety of inflammatory conditions.
Key Highlights from the Phase 1a Trial
- Safety Profile: ATI-052 was well tolerated across all dose cohorts, including doses of up to 720 mg.
- Pharmacokinetics: The trial identified a promising pharmacokinetic profile, demonstrating an effective half-life of at least 26 days.
- Target Engagement: Evidence of robust pharmacodynamics was noted, including complete inhibition of IL-4 and TSLP stimulated CCL17/TARC even at low doses.
- Future Trials: Aclaris plans to initiate Phase 1b proof-of-concept trials for atopic dermatitis (AD) and asthma within Q1 2026, with a Phase 2b trial in AD expected in the second half of 2026.
Management Insights
Dr. Neal Walker, CEO of Aclaris, expressed optimism about the trial results, stating, “These results reinforce the potential best-in-class potency of ATI-052. We are excited to advance the clinical development of this compound, as it may uniquely address critical pathways involved in various inflammatory diseases.”
Detailed Interim Results
The Phase 1a trial was a randomized, double-blind, placebo-controlled study. It evaluated the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneously administered ATI-052 in healthy adults, utilizing both single ascending doses (SAD) and multiple ascending doses (MAD).
In the SAD portion, each of four cohorts of eight healthy volunteers received a single dose of ATI-052 at 30, 120, 360, or 720 mg, or a placebo. Meanwhile, two cohorts in the MAD portion received multiple doses at 240 or 480 mg every seven days.
Results showed a favorable safety profile across the trial, with most treatment-emergent adverse events (TEAEs) classified as Grade 1, primarily mild injection site reactions. Notably, no Grade 3 TEAEs or serious adverse events were reported, which further establishes the safety of ATI-052.
Next Steps for Aclaris
Following the positive interim findings, Aclaris intends to accelerate the clinical development of ATI-052. The company expects to launch the Phase 1b proof-of-concept trials for atopic dermatitis and asthma shortly, with preliminary data anticipated by the second half of 2026.
“Advancements in our pipeline, particularly with ATI-052, showcase our commitment to addressing unmet needs in immuno-inflammatory diseases,” added Dr. Walker.
About ATI-052
ATI-052 is an investigational humanized bispecific antibody targeting thymic stromal lymphopoietin (TSLP) and interleukin-4 receptor alpha (IL-4Rα). It is designed to inhibit central proinflammatory pathways involved in various allergic and immunological diseases, potentially offering a new treatment approach for patients suffering from conditions like atopic dermatitis and asthma. Aclaris holds exclusive worldwide rights to ATI-052, excluding Greater China.
Company Overview
Aclaris Therapeutics, Inc. is dedicated to developing innovative therapies to address the needs of patients with immuno-inflammatory conditions inadequately managed by existing treatments. For more information, visit aclaristx.com.
Conference Call Information
Aclaris will host a webcast and conference call to discuss the interim results of the Phase 1a trial today at 8:00 AM EST. The live and archived webcast can be accessed on the Company's Events page.