Biopharma · FDA Approvals · Stock
Aclaris Therapeutics Inc is a clinical-stage biopharmaceutical company. It focuses on developing novel drug candidates for immuno-inflammatory diseases using its proprietary KINect drug discovery platform. The company's pipeline consists of the following key product candidates: Bosakitug (ATI-045), an investigational, …
Assets on file: ATI-052, modzatinib
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Aclaris Reports Positive Phase 1b POC Results for ATI-052 in AD and Asthma; Prioritizes EoE Phase 2b
Aclaris announced positive primary analysis results from two Phase 1b proof-of-concept trials of ATI-052 showing rapid, broad efficacy in severe AD (EASI and itch improvements) and mild-to-moderate asthma (FeNO and FEV1 improvements), plus favorable safety with no conjunctivitis. The company will prioritize Phase 2b development in eosinophilic esophagitis, with initiation planned for early 2027.
Aclaris: FDA grants Fast Track for modzatinib (ATI-2138) in LP
The FDA granted Fast Track designation to modzatinib for moderate to severe lichen planus, enabling more frequent FDA interactions, rolling NDA review, and potential Priority Review eligibility. Aclaris plans to start a Phase 2b trial in Q4 2026.
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