Aclaris Therapeutics announced positive interim results from the first-in-human Phase 1a single (SAD) and multiple ascending dose (MAD) trial of its anti-TSLP/IL-4Rα bispecific antibody ATI-052.
The results reinforce the potential best-in-class potency advantage of ATI-052 and support extended dosing intervals of up to every three months.
Phase 1b proof-of-concept trials in Atopic Dermatitis (AD) and Asthma are expected to start in the first quarter of 2026, with plans for a Phase 2b trial in AD in the second half of 2026.
Significant Momentum in Pipeline
Aclaris has experienced significant momentum across their pipeline, with positive interim results exceeding expectations.
Strong Safety Profile
ATI-052 demonstrated a strong safety and tolerability profile, dose proportional pharmacokinetics, and concentration-dependent pharmacodynamics at the lowest dose.
Clinical Development Advancement
Interim results support rapid advancement of ATI-052's clinical development with Phase 1b trials in AD and asthma imminent and Phase 2b planning in progress.
- The Phase 1a trial demonstrated that ATI-052 was well tolerated and exhibited a favorable safety profile across all SAD and MAD cohorts.
- ATI-052 showed a potential best-in-class pharmacokinetic profile with at least a 26-day effective half-life, supporting up to three-month dosing intervals.
- The strong pharmacokinetic duration combined with sustained and potent pharmacodynamic effects validate the compound's potential in treating inflammatory and immunological diseases.
The positive interim results from the Phase 1a trial of ATI-052 mark a significant step forward for Aclaris Therapeutics, reinforcing the compound's potential in immuno-inflammatory diseases and paving the way for further clinical development.