Core Viewpoint - Aclaris Therapeutics, Inc. is actively participating in two healthcare conferences in February 2026, showcasing its commitment to addressing immuno-inflammatory diseases through innovative product candidates [1][4]. Company Overview - Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel product candidates for patients with 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]. Upcoming Events - On February 12, 2026, at 2:30 PM EST, Aclaris' CEO Dr. Neal Walker and senior leadership will participate in a fireside chat at the Guggenheim Emerging Outlook: Biotech Summit 2026 in New York, NY [4]. - On February 26, 2026, at 8:40 AM EST, Aclaris' President and COO Hugh Davis, Ph.D. will deliver a corporate presentation during the virtual Oppenheimer 36th Annual Healthcare Life Sciences Conference [4].

Core Insights - Aclaris Therapeutics announced positive preclinical results for ATI-2138, a potent ITK/JAK3 inhibitor, showing significant hair regrowth in a murine model of severe alopecia areata compared to ritlecitinib [1][2][3] Group 1: Drug Efficacy - ATI-2138 demonstrated rapid and near-complete hair regrowth in mice, achieving 87% regrowth at week 4 and 93% at week 6, compared to 48% and 78% for ritlecitinib respectively [3] - The study utilized a reversal model of alopecia universalis, indicating that ATI-2138 is effective even in older and more difficult-to-treat mice [2][3] Group 2: Mechanism of Action - ATI-2138 acts as a dual inhibitor of ITK and JAK3, affecting T cell receptor signaling and regulating T cell expansion and activation [2][7] - The drug is highly selective, being over 1,000-fold more potent against ITK and JAK3 than other JAK isoforms, which may lead to a strong anti-inflammatory response [2][7] Group 3: Future Development - Aclaris plans to initiate a Phase 2b trial for ATI-2138 in the first half of 2026, exploring its potential in treating various inflammatory and autoimmune diseases, including alopecias [6][10] - The company is assessing additional indications for ATI-2138, leveraging its unique pharmacological profile [6][10] Group 4: Company Overview - Aclaris Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel treatments for immuno-inflammatory diseases, with a robust R&D pipeline [8] - The company aims to address unmet medical needs in patients suffering from conditions that lack satisfactory treatment options [8]

Core Insights - Aclaris Therapeutics announced positive preclinical results for its ITK/JAK3 inhibitor ATI-2138, showing significant hair regrowth in a murine model of severe alopecia areata [1][2][3] Group 1: Drug Mechanism and Efficacy - ATI-2138 is a potent and selective dual inhibitor of ITK and JAK3, effectively downregulating various inflammatory markers and reducing itch, making it suitable for treating immuno-inflammatory diseases [2][6] - In a murine model, mice treated with 300 ppm ATI-2138 showed a mean hair regrowth of 37% at week 2 and 87% at week 4, compared to ritlecitinib's 25% and 48% respectively [3] - By week 6, the mean hair regrowth for ATI-2138 reached 93%, significantly outperforming ritlecitinib, which achieved 78% [3] Group 2: Future Development Plans - Aclaris plans to initiate a Phase 2b trial for ATI-2138 in the first half of 2026, exploring its potential in treating various inflammatory and autoimmune diseases, including alopecias [5][6] - The company is assessing additional indications for ATI-2138, leveraging its unique pharmacological profile to address unmet medical needs in immuno-inflammatory conditions [5][6] Group 3: Company Overview - Aclaris Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapies for patients with immuno-inflammatory diseases lacking satisfactory treatment options [7] - The company has a robust R&D pipeline aimed at addressing various inflammatory diseases, supported by preclinical and clinical data demonstrating the efficacy of its product candidates [7]

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 ...