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Aclaris Therapeutics
Aclaris Therapeutics (ACRS) investor relations material
Aclaris Therapeutics Study Result summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Study Result summary6 Jan, 2026
Study Overview and Scientific Rationale
ATI-052 is a bispecific antibody targeting TSLP and IL-4Rα, blocking TSLP, IL-4, and IL-13 signaling for potential best-in-class efficacy in inflammatory and immune disorders.
The molecule features high-affinity binding, slow dissociation kinetics, and engineered Fc mutations for extended half-life and reduced off-target toxicity.
Demonstrates significantly longer residence time on TSLP (over 400 hours) compared to competitors, supporting enhanced potency.
Exhibits broad and synergistic inhibition of CCL17 production, outperforming combinations of approved antibodies in ex vivo assays.
Potential applications include dermatological, respiratory, and other Th2-mediated diseases.
Phase 1A Trial Design and Results
Phase 1a included single and multiple ascending dose cohorts in healthy adults, evaluating safety, tolerability, PK, and PD, with doses ranging from 30 mg to 720 mg.
ATI-052 was well tolerated up to 720 mg, with no serious adverse events, no discontinuations, and most adverse events being mild and self-resolving injection site reactions.
No cases of conjunctivitis or grade 3 drug-related adverse events were observed.
PK analysis showed dose-proportional increases, linear PK, and an effective half-life of at least 26 days, supporting extended dosing intervals.
Drug concentrations remained above the TMDD threshold for 6–8 weeks after a single dose and at least 8 weeks after MAD dosing.
Pharmacodynamics and Clinical Implications
ATI-052 achieved strong and sustained inhibition of CCL17 in whole blood assays, with complete or near-complete inhibition at pharmacologically relevant doses.
Inhibition was more pronounced for TSLP than IL-4, attributed to the molecule's design and high TSLP binding potency.
Sustained PD effects exceeded predictions based on PK, supporting the potential for up to three-month maintenance dosing.
ATI-052 demonstrated greater potency than comparator antibodies, including the combination of Dupilumab and Tezepelumab.
Additional biomarker analyses are ongoing to further validate clinical translation.
ATI-052's specific competitive advantages?
What enables the 3-month dosing potential?
What drives the expedited AD development timeline?
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Next Aclaris Therapeutics earnings date
Q4 202527 Feb, 2026
Aclaris Therapeutics
Next Aclaris Therapeutics earnings date
Q4 202527 Feb, 2026
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Frequently asked questions
Aclaris Therapeutics Inc. is a clinical-stage biopharmaceutical company primarily engaged in the development of novel drug candidates for immuno-inflammatory diseases. Leveraging its core expertise in drug discovery, development, and kinase inhibition, Aclaris focuses on creating small molecule therapies for people affected by underserved immuno-inflammatory conditions. Its proprietary KINect® technology platform enables the development of clinical candidates targeting challenging kinases with novel approaches. Additionally, Aclaris operates Confluence Discovery Technologies, Inc., a full-service drug discovery and early development contract research organization. This subsidiary offers research partnership services across therapeutic areas and gene families, with expertise in a range of scientific disciplines including cell and molecular biology, biochemistry, enzymology, and immunology. he company is headquartered in Wayne, Pennsylvania, and its shares are listed on the Nasdaq.
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