WAYNE, PA — Aclaris Therapeutics, Inc. (NASDAQ: ACRS) has announced the initiation of a Phase 2 trial for its investigational drug bosakitug (ATI-045), targeting moderate-to-severe atopic dermatitis (AD). This randomized, double-blind, placebo-controlled trial marks a significant step forward for the Pennsylvania-based biotech firm as it aims to position bosakitug as a potential best-in-class therapeutic for this widespread chronic condition.
Study Details
The global trial, involving approximately 90 patients, is designed to evaluate the efficacy and safety of bosakitug. The primary endpoint is the percent change from baseline in the Eczema Area and Severity Index (EASI) at week 24. Secondary endpoints include response rates such as EASI-50, EASI-75, and EASI-90, as well as scores measuring body surface area (BSA) affected, validated Investigator Global Assessment (IGA), and Peak Pruritus Numerical Rating Scale (PP-NRS). Safety and tolerability will also be closely monitored.
Dr. Jesse Hall, Chief Medical Officer of Aclaris, highlighted the promising data from the earlier Phase 2a trial. “We are excited to initiate this Phase 2 trial following the strong single-arm Phase 2a results in patients with moderate-to-severe AD,” said Hall. “Bosakitug demonstrated improvements in efficacy measures at week 26, including EASI-75 scores in 94% of participants and clear or nearly clear skin in 88% of participants as measured by IGA scores of 0/1. We expect to provide top-line results from this trial in the second half of 2026.”
Unpacking Bosakitug’s Potential
Bosakitug is a humanized monoclonal antibody specifically targeting thymic stromal lymphopoietin (TSLP), a cytokine central to Type 2 (Th2) immune responses in allergic and inflammatory diseases. It works by binding to TSLP, blocking its receptor interactions and preventing the release of proinflammatory cytokines. Bosakitug’s high affinity, potent binding, and prolonged activity distinguish it from other therapies, potentially allowing extended dosing intervals.
Beyond atopic dermatitis, bosakitug shows promise in treating a variety of atopic, immunologic, and respiratory diseases. The company retains exclusive worldwide rights to the drug, excluding Greater China.
The Burden of Atopic Dermatitis
Atopic dermatitis is the most common form of eczema and affects more than 200 million people globally. In the United States alone, it impacts 10 million children and 17 million adults. Among those affected, roughly 40% experience moderate-to-severe symptoms such as persistent itching, inflammation, and skin damage, significantly diminishing quality of life.
AD’s broader implications include higher risks of sleep disturbances and social dysfunction, underscoring the urgent need for effective new treatments.
Transformative Prospects
If successful in demonstrating efficacy and safety, bosakitug could mark a significant advance in the treatment landscape for atopic dermatitis. The drug’s unique mechanism of action and impressive early trial results position it as a frontrunner in addressing unmet needs for those with moderate-to-severe AD.
The Phase 2 trial’s results, expected in the latter half of 2026, are anticipated to shed further light on Aclaris’ commitment to advancing therapeutic innovation for this chronic and complex condition.
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