Core Insights - Aclaris Therapeutics has initiated a Phase 1b proof-of-concept trial for ATI-052, a bispecific anti-TSLP/IL-4Rα antibody targeting atopic dermatitis [1][2] - The company is experiencing strong momentum in the clinical development of ATI-052, following positive Phase 1a interim results [2] - Aclaris plans to initiate a second Phase 1b trial for asthma in the first quarter of 2026, with top-line results from both trials expected in the second half of 2026 [3] Company Overview - Aclaris Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases [5] - The company has a robust R&D engine and a multi-stage portfolio aimed at addressing unmet medical needs in patients with immuno-inflammatory conditions [5] Product Details - ATI-052 is designed to inhibit both thymic stromal lymphopoietin (TSLP) and interleukin-4 receptor (IL-4Rα), potentially offering a best-in-class treatment option for various atopic and immunologic diseases [4] - The antibody exhibits high affinity and potency, with engineered properties to extend its half-life, enhancing its therapeutic potential [4]

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Core Viewpoint - Aclaris Therapeutics has announced positive interim results from its ATI-052 Phase Ia clinical trial, which involved both single and multiple ascending doses [1]. Group 1: Clinical Trial Results - The conference call was held to review the interim results of the ATI-052 trial, indicating a significant step forward for the company [1]. - The press release detailing these clinical results was made available on the company's Investor Relations website [1]. Group 2: Communication and Presentation - The conference included a presentation with slides that are accessible as a downloadable PDF document during the webcast [2]. - A Q&A session was scheduled to follow the prepared remarks, allowing for further discussion on the trial results [2].

Aclaris Therapeutics Conference Call Summary Company Overview - **Company**: Aclaris Therapeutics (NasdaqGS: ACRS) - **Focus**: Development of therapies for inflammatory and immune disorders (I&I) Key Points from the Conference Call Clinical Trial Update - **Trial**: Positive interim results from the ATI-052 phase 1a single and multiple ascending dose trial were discussed [2][4] - **Date of Results**: Interim results as of December 31, 2025 [3] ATI-052 Overview - **Mechanism**: ATI-052 is a bispecific antibody that binds both TSLP (Thymic Stromal Lymphopoietin) and IL-4R (Interleukin-4 Receptor) to block signaling pathways associated with I&I disorders [4][5] - **Efficacy**: The compound shows strong safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profiles, indicating potential best-in-class efficacy [4][5][11] Safety and Tolerability - **Adverse Events**: Low rate of adverse events (AEs) observed, predominantly grade 1, with no serious AEs reported [15][16] - **Injection Site Reactions**: Most common AE was mild injection site redness, self-resolving [15][16] Pharmacokinetics (PK) and Pharmacodynamics (PD) - **PK Profile**: Effective half-life of at least 26 days, significantly longer than Dupilumab [18] - **PD Results**: ATI-052 showed complete inhibition of CCL17 production at low doses, indicating strong efficacy in modulating immune responses [21][23] Future Development Plans - **Upcoming Trials**: - Phase 1b proof-of-concept trial in atopic dermatitis to start imminently [23] - Second phase 1b trial in asthma expected to follow shortly [23] - Phase 2b trial planned for the second half of 2026 to assess extended dosing schedules [6][24] Competitive Landscape - **Market Positioning**: Aclaris aims to position ATI-052 as a best-in-class therapy for both dermatological and respiratory indications, competing with existing therapies like Dupilumab [33][34] - **Dosing Schedule**: Potential for extended dosing intervals of up to three months, which could enhance patient compliance and market appeal [23][34] Additional Insights - **Biomarker Analysis**: CCL17 (TARC) is highlighted as a robust biomarker for assessing the drug's efficacy [42] - **Patient Enrollment Strategy**: Ongoing discussions regarding the mix of biologically naive and experienced patients for upcoming trials [60][64] Conclusion - Aclaris Therapeutics is optimistic about the potential of ATI-052 based on the interim results, with plans for accelerated clinical development and a focus on both dermatological and respiratory indications. The company is building a strong pipeline and aims to deliver innovative therapies to the market [67]

ATI-052: Anti-TSLP x IL-4Rα Bispecific Antibody Program Highly Potent and Bioactive Investigational Product Candidate January 6, 2026 Disclaimer and Cautionary Note Regarding Forward-Looking Statements Any statements contained in this presentation that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "anticipate," "believe," "expect," "intend," "may," ...

Core Insights - Aclaris Therapeutics announced positive interim results from the Phase 1a single ascending dose (SAD) and multiple ascending dose (MAD) trial of ATI-052, indicating its potential as a best-in-class treatment for immuno-inflammatory diseases [1][2] Group 1: Trial Results - The Phase 1a trial was randomized, blinded, and placebo-controlled, evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ATI-052 in healthy adults [3] - Interim results showed that ATI-052 was well tolerated with a favorable safety profile across all cohorts, with no serious adverse events reported [4] - The most common treatment-emergent adverse event (TEAE) was mild injection site redness, and no conjunctivitis was observed [4] - ATI-052 demonstrated a potential best-in-class PK profile with an effective half-life of at least 26 days and dose proportional increases in maximum peak concentration (Cmax) and area under the curve (AUC) [4] Group 2: Efficacy and Dosing Potential - At the lowest dose of 30 mg, ATI-052 showed robust concentration-dependent inhibition of IL-4 and TSLP stimulated CCL17/TARC, with complete inhibition observed at higher doses [10] - The combination of PK duration and strong sustained PD effects supports the potential for dosing every three months [10] Group 3: Future Development Plans - Aclaris plans to initiate Phase 1b proof-of-concept trials in atopic dermatitis (AD) and asthma in early 2026, with top-line data expected in the second half of 2026 [5] - Planning is also underway for a Phase 2b trial of ATI-052 in AD, anticipated to start in the second half of 2026 [5] Group 4: Company Overview - Aclaris Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, with a robust R&D pipeline [8]

WAYNE, Pa., Dec. 19, 2025 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced it has been added to the Nasdaq Biotechnology Index (NASDAQ: NBI), effective at the close of trading today, December 19, 2025. The NBI is designed to track the performance of a set of securities listed on The Nasdaq Stock Market® that are classified as either biotechnology or pharma ...

Aclaris Therapeutics FY Conference Summary Company Overview - Aclaris Therapeutics is a development-stage biotech company focused on large and small molecule therapeutics, leveraging expertise from large pharma and a robust discovery platform [2][3] Pipeline and Clinical Assets - Aclaris has three clinical-stage assets: - **O52**: An IL-4 and TSLP bispecific antibody currently undergoing SAD/MAD studies - **TSLP mAb**: Targeting moderate-to-severe atopic dermatitis, with results expected next year - **2138**: An ITK JAK3 oral inhibitor, with a lead indication expected to start next year [2][3] - By 2026, Aclaris anticipates having four clinical-stage assets, with a cash runway extending into Q3 2028, holding $167 million on the balance sheet [3] Financial Management - The company maintains a modest cash burn of approximately $10 million to $13 million per quarter, allowing for efficient management of multiple programs [4] TSLP mAb Program - The TSLP mAb is positioned to address multi-billion-dollar markets, particularly in atopic dermatitis, with expectations of best-in-class potency [4][5] - Aclaris claims their TSLP mAb is 70 times more potent than Tezspire, with a focus on improving residence time and binding efficacy in the skin [8][10] Clinical Trial Design and Strategy - Aclaris is implementing central photography and adjudication to minimize placebo effects in clinical trials, ensuring accurate patient enrollment [13][15] - The company is open to including patients who have previously failed treatments like Dupixent, as TSLP operates through a different mechanism [21] Upcoming Data and Expectations - Significant data from the TSLP mAb program is expected in the second half of 2026, with a focus on responder rates and efficacy measures [24][41] - The bispecific TSLP-IL-4 program is currently in phase one SAD-MAD studies, with early data anticipated next year [30][36] New Indications and Market Strategy - Aclaris is pursuing lichen planus as a lead indication for their ITK program, targeting a market with less competitive intensity and a prevalence of 2% [45][46] - The company plans to initiate a phase two trial with a placebo control, enrolling approximately 70-80 patients [47] JAK-Sparing ITK Development - Aclaris is developing a JAK-sparing ITK molecule, aiming for IND submission by the end of 2026, targeting both respiratory and dermatological indications [57][59] Multi-Specific Antibody Platform - The company is exploring multi-specific antibodies using TSLP as a backbone, with plans to disclose more information as development progresses [62][64] Conclusion - Aclaris Therapeutics is positioned for significant growth with multiple clinical assets and a strong financial foundation, with 2026 expected to be a pivotal year for data releases and potential market entries [66]

Core Insights - Aclaris Therapeutics, Inc. is participating in the Piper Sandler 37th Annual Healthcare Conference in New York City on December 2, 2025, at 11:00 AM EST [1] - The company focuses on developing novel product candidates for immuno-inflammatory diseases [3] Company Overview - Aclaris Therapeutics is a clinical-stage biopharmaceutical company with a pipeline aimed at addressing the needs of patients suffering from immuno-inflammatory diseases who currently lack satisfactory treatment options [3] - The company boasts a multi-stage portfolio of product candidates supported by a robust research and development engine [3] Communication and Accessibility - A live and archived webcast of the conference participation will be available on Aclaris' website for at least 30 days [2]

Aclaris Therapeutics Conference Call Summary Company Overview - Aclaris Therapeutics is a clinical-stage biopharmaceutical company focused on large and small molecule therapeutics with three clinical-stage assets and one preclinical-stage asset expected to enter IND in 2026 [4][30] Key Clinical Assets 1. **2138**: An oral small molecule inhibitor of ITK and JAK3, recently reported positive top-line data in atopic dermatitis (AD) [4] - Plans to move to indications in lichen planus or scarring alopecia in 2026 [4] 2. **045**: A best-in-class TSLP monoclonal antibody currently in a Phase 2 study for moderate to severe atopic dermatitis [4][7] - Demonstrated a resonance time binding to TSLP for over 400 hours, significantly longer than competitors [7] - Phase 2A results showed 94% of subjects had EASI75 response and 88% had IGA0/1 [7] 3. **Bispecific Antibody**: Combines TSLP with IL4R, undergoing SAD/MAD studies with data expected in early 2026 [5][18] - Expected to show greater potency than existing treatments like Dupixent and Tezspire [19] 4. **Next-Gen ITK Inhibitor**: Engineered to remove the JAK3 component, targeting TH2 and TH1 diseases, with IND expected in the second half of 2026 [5][30] Clinical Development Strategy - Aclaris is focusing on a dual review process in clinical trials to ensure accurate patient enrollment and data integrity [11][12] - The company is strategically positioning its assets to address unmet medical needs in both dermatological and respiratory indications [19][39] Market Opportunities - **Atopic Dermatitis**: High unmet need with existing treatments showing limited efficacy in a significant portion of patients [19] - **Lichen Planus and Scarring Alopecia**: No approved treatments currently exist, presenting a significant market opportunity [39] - Lichen planus has a prevalence of about 1%, while scarring alopecia is considered orphan with around 50,000 patients [41] Financial Position - Aclaris has approximately $170 million on its balance sheet, providing a runway into Q3 2028 [43] - The company maintains a burn rate of $10-$13 million per quarter, indicating efficient capital management [43] Upcoming Milestones - Multiple data readouts expected in 2026, including: - Phase 2 data for TSLP MAB and bispecific antibody studies [20][43] - IND submission for next-gen ITK inhibitor [43] Conclusion - Aclaris Therapeutics is well-positioned with a diverse pipeline targeting significant unmet medical needs in dermatology and respiratory diseases, supported by a strong financial position and strategic clinical development plans [43][44]