Aclaris Therapeutics, Inc.

Aclaris Therapeutics Announces Positive Phase 1b Proof-of-Concept Primary Analysis Results for its Anti-TSLP/IL-4Rα Bispecific ATI-052 in Atopic Dermatitis (AD) and Asthma

Aclaris reported positive Phase 1b proof-of-concept results for its anti-TSLP/IL-4Rα bispecific ATI-052 in atopic dermatitis and asthma, with both trials meeting their primary objectives. In severe AD, ATI-052 delivered a 45% placebo-adjusted EASI improvement and 43% placebo-adjusted itch improvement at day 57; a single dose cut FeNO 59% and improved FEV1 by 200 ml in asthma at day 15. Safety was clean, with no Grade 3/4 adverse events and no conjunctivitis observed. Aclaris will prioritize Phase 2b development in eosinophilic esophagitis, with a trial expected to start early next year. The early data, if replicated in larger trials, position ATI-052 as a potential best-in-class dual-mechanism biologic across immuno-inflammatory indications.

•5d ago

Aclaris Therapeutics Receives Fast Track Designation for Modzatinib (ATI-2138) for Moderate to Severe Lichen Planus (LP)

Aclaris Therapeutics received Fast Track Designation from the FDA for modzatinib (ATI-2138) for the treatment of moderate to severe lichen planus, including oral erosive and cutaneous forms. The designation allows for more frequent FDA interactions and rolling review of a New Drug Application, potentially expediting the path to registration. The company expects to initiate a phased multi-part Phase 2b trial of modzatinib in the fourth quarter of 2026.

•2mo ago

Aclaris Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate and Clinical Update

Aclaris Therapeutics reported Q2 2026 revenue of $1.6 million with a net loss of $21.5 million, while subsequent ATM sales of 7.3 million shares raised $40.2 million to extend its cash runway into the end of 2028. The company announced positive full top-line results from the Phase 1a trial of ATI-052, demonstrating a favorable safety profile and pharmacokinetics that support potential quarterly dosing. Upcoming catalysts include Phase 1b proof-of-conience data for ATI-052 in the second half of 2026 and Phase 2 results for Bosakitug in the fourth quarter of 2026.

•2mo ago

Aclaris Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate and Clinical Update

Aclaris reported positive Phase 1a data for ATI-052, showing a 45-day half-life and target engagement supporting dosing every three months, confirming its best-in-class potential. The company ended Q1 with $190.8 million in cash, sufficient to fund operations through 2028, following a $59.8 million ATM offering in March. Management expects multiple catalysts in the second half of 2026, including Phase 1b POC data for ATI-052 in asthma and atopic dermatitis, and Phase 2 data for bosakitug.

•5mo ago

Aclaris Therapeutics Announces Positive Full Top Line First-in-Human Results from Phase 1a Healthy Volunteer Clinical Trial of ATI-052, a Novel Potential First-in-Class Anti-TSLP/IL-4Rα Bispecific Antibody, and Announces Lichen Planus as Lead Indication for ATI-2138, an Oral ITK/JAK3 Inhibitor

Aclaris reported positive full Phase 1a results for ATI-052, showing an estimated half-life of 45 days that supports dosing every three months and robust inhibition of inflammatory biomarkers. The company plans to initiate a Phase 2b program for ATI-052 in asthma by Q4 2026, with top-line Phase 1b results in asthma and atopic dermatitis expected in the second half of this year. Aclaris selected lichen planus as the lead indication for ATI-2138, targeting a market opportunity estimated between $1 billion and $4 billion with a Phase 2b study expected to begin in the second half of 2026.

•6mo ago