Aclaris Therapeutics (NASDAQ:ACRS) announced it has successfully completed patient enrollment for its Phase 2 clinical trial of bosakitug (ATI-045), an investigational treatment for patients suffering from moderate-to-severe atopic dermatitis.
The randomized, double-blind, placebo-controlled study reached its recruitment target with a total of 109 patients.
The trial is designed to evaluate the efficacy and safety of bosakitug over a 24-week period.
The primary endpoint is the percent change from baseline in the Eczema Area and Severity Index (EASI) score at week 24.
Researchers are also tracking several secondary clinical markers, including the proportion of patients achieving EASI-50, EASI-75, and EASI-90, as well as improvements in the Investigator Global Assessment (IGA), Body Surface Area (BSA) involvement, and the Peak Pruritus Numerical Rating Scale (PP-NRS) for itch relief.
Aclaris highlighted several key attributes of bosakitug that may distinguish it within the competitive dermatology market.
The compound possesses a 23-day natural half-life, which the company believes could translate into significant dosing convenience for patients compared to existing therapies.
In addition to clinical efficacy, the study will assess safety, pharmacokinetic (PK) profiles, and various pharmacodynamic (PD) biomarkers to better understand the drug's mechanism of action.
With enrollment now finalized, the company remains on track to report top-line results in the fourth quarter of 2026.