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Aclaris Therapeutics (ACRS) investor relations material
Aclaris Therapeutics Guggenheim Securities Emerging Outlook: Biotech Summit 2026 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Pipeline overview and development updates
Focus on large and small molecule therapeutics, including TSLP monoclonal antibody and bispecifics, with key readouts expected in late 2026.
TSLP monoclonal antibody in a 90-patient phase II study for atopic dermatitis, aiming for best-in-class efficacy and potential for extended dosing intervals of 2-3 months.
Bispecific antibody targeting TSLP and IL-4R demonstrated a 26-day half-life and strong target engagement in healthy volunteers, with phase 1b studies in AD and asthma underway.
Oral ITK/JAK3 inhibitor (ATI-2138) showed strong efficacy and safety in atopic dermatitis, with lead indication selection imminent.
Next-generation ITK-selective compounds, including ITK/TXK variants, are advancing toward IND filings, with clinical entry expected in the coming months.
Clinical and mechanistic insights
TSLP antibody outperformed Tezspire in potency and showed high EASI-75 and IGA 0/1 rates in prior studies, supporting its advancement.
Bispecific approach aims for deeper and broader efficacy by targeting both TSLP and IL-4R, addressing both T2 high and T2 low asthma and atopic dermatitis populations.
Injection site reactions were the most common adverse event for the bispecific, but were mild, transient, and not dose-related.
Phase 1b studies in severe AD and moderate asthma are designed for robust PK/PD and efficacy readouts, with endpoints aligned to industry standards.
ITK inhibitors leverage covalent binding for selectivity and potency, overcoming historical challenges with reversible inhibitors.
Competitive positioning and future outlook
ITK/JAK3 inhibitor ATI-2138 demonstrated balanced, potent activity and favorable safety, with potential differentiation from existing JAK inhibitors.
Indications under consideration include alopecia and lichen planus, with head-to-head data suggesting superior efficacy versus ritlecitinib.
Next-gen ITK-selective compounds offer flexibility to target Th2/Th17 or Th1 biology, broadening potential indications.
Safety profile of ITK inhibitors is expected to be favorable, with less global immunosuppression compared to other JAK inhibitors.
Oral small molecules are positioned as complementary to biologics, with significant market opportunity across multiple immune-mediated diseases.
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