Aclaris Therapeutics has started a placebo‑controlled Phase 1b proof‑of‑concept study of its bispecific antibody ATI‑052 in patients with asthma. The study will enroll about 16 participants and will assess safety, tolerability, pharmacokinetics, pharmacodynamics, and early efficacy signals such as forced expiratory volume in one second, fractional exhaled nitric oxide, and blood eosinophil counts.
ATI‑052 targets two key drivers of Th2‑mediated inflammation by simultaneously blocking thymic stromal lymphopoietin and the interleukin‑4 receptor alpha subunit. The dual‑target approach is designed to intercept both upstream and downstream signals in the allergic cascade, potentially offering greater clinical benefit than single‑target therapies.
Top‑line data from the asthma study and a parallel Phase 1b study in atopic dermatitis are expected in the second half of 2026. Aclaris plans to launch a Phase 2b program if the early results are encouraging, positioning ATI‑052 as a candidate for multiple immuno‑inflammatory indications.
Aclaris has reported revenue growth over the past three years but continues to face margin pressures and negative operating and net margins. Dr. Jesse Hall, Chief Medical Officer, said, “The positive Phase 1a interim results for ATI‑052 exceeded our expectations and demonstrated a strong safety and tolerability profile, extended pharmacokinetics, and concentration‑dependent pharmacodynamics even at the lowest dose.” The company’s liquidity remains robust, giving it the runway to fund the planned clinical development.
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