Aclaris Therapeutics Announces Positive Interim Results of Phase 1a Trial of Anti-TSLP/IL-4Rα Bispecific Antibody ATI-052 Supporting Expedited Clinical Development

Core Insights - Aclaris Therapeutics announced positive interim results from the Phase 1a single ascending dose (SAD) and multiple ascending dose (MAD) trial of ATI-052, indicating its potential as a best-in-class treatment for immuno-inflammatory diseases [1][2] Group 1: Trial Results - The Phase 1a trial was randomized, blinded, and placebo-controlled, evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ATI-052 in healthy adults [3] - Interim results showed that ATI-052 was well tolerated with a favorable safety profile across all cohorts, with no serious adverse events reported [4] - The most common treatment-emergent adverse event (TEAE) was mild injection site redness, and no conjunctivitis was observed [4] - ATI-052 demonstrated a potential best-in-class PK profile with an effective half-life of at least 26 days and dose proportional increases in maximum peak concentration (Cmax) and area under the curve (AUC) [4] Group 2: Efficacy and Dosing Potential - At the lowest dose of 30 mg, ATI-052 showed robust concentration-dependent inhibition of IL-4 and TSLP stimulated CCL17/TARC, with complete inhibition observed at higher doses [10] - The combination of PK duration and strong sustained PD effects supports the potential for dosing every three months [10] Group 3: Future Development Plans - Aclaris plans to initiate Phase 1b proof-of-concept trials in atopic dermatitis (AD) and asthma in early 2026, with top-line data expected in the second half of 2026 [5] - Planning is also underway for a Phase 2b trial of ATI-052 in AD, anticipated to start in the second half of 2026 [5] Group 4: Company Overview - Aclaris Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, with a robust R&D pipeline [8]