Aclaris Therapeutics has finished enrolling 109 patients in its randomized, double‑blind, placebo‑controlled Phase 2 study of bosakitug (ATI‑045) for moderate‑to‑severe atopic dermatitis. The trial, which began enrolling in May 2025, now has a full cohort and will deliver top‑line results in the fourth quarter of 2026.
Bosakitug is a humanized anti‑TSLP monoclonal antibody that blocks thymic stromal lymphopoietin, a key driver of type‑2 inflammation in atopic dermatitis. In a single‑arm Phase 2a study, the drug achieved a 94 % EASI‑75 response at week 26 and 88 % of patients reached clear or nearly clear skin (IGA 0/1). The Phase 2 trial will evaluate percent change from baseline in EASI at week 24, along with EASI‑50/75/90, IGA response, BSA response, and pruritus scores.
Bosakitug’s long half‑life of 23 days and high affinity for TSLP position it as a potentially best‑in‑class biologic that could offer sustained skin benefit with infrequent dosing. Aclaris holds exclusive worldwide rights to the asset, excluding Greater China, through a license with Biosion, adding a new biologic platform to its immuno‑inflammatory pipeline.
Aclaris released its fourth‑quarter and full‑year 2025 financial results on February 26 2026. Total revenue fell compared with the prior year, largely because a commercial milestone payment was received in Q4 2024. Research and development expenses rose as the company invested in bosakitug and other pipeline candidates, while the net loss narrowed year‑over‑year. Cash, cash equivalents, and marketable securities stood at $151.4 million as of December 31 2025, giving the company a runway into the second half of 2028.
In a statement on the earnings release, CEO Dr. Neal Walker highlighted the company’s strong execution in 2025 and its positioning for an “exciting 2026 with important milestones and data readouts expected from each program.” He emphasized that the enrollment milestone is a critical step toward the upcoming data readout and that the company remains focused on advancing its best‑in‑class programs.
No specific market reaction to the enrollment announcement was reported. Prior to this news, Aclaris’s stock had risen 3.74 %, outperforming several key biotech peers, suggesting that company‑specific factors were driving its performance rather than sector‑wide trends.
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