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]

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]

Core Insights - Aclaris Therapeutics, Inc. has appointed Roland Kolbeck, Ph.D. as the new Chief Scientific Officer, succeeding Joe Monahan, Ph.D., who will transition to a Special Scientific Advisor role until March 2026 as part of his planned retirement [1][2] - Dr. Kolbeck brings nearly three decades of experience in R&D leadership and a strong track record in drug development, particularly in immuno-inflammatory diseases [2][3] - The company is focused on developing a pipeline of novel product candidates, including next-generation kinase and cytokine signaling pathway inhibitors and potential first-in-class bispecific antibodies [1][2] Company Overview - Aclaris Therapeutics is a clinical-stage biopharmaceutical company dedicated to addressing the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options [3] - The company has a multi-stage portfolio powered by a robust R&D engine, indicating a strong commitment to innovation and therapeutic development [3]

Core Insights - Aclaris Therapeutics has initiated a Phase 2 trial for bosakitug, an investigational monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), in patients with moderate-to-severe atopic dermatitis (AD) [1][2] - The trial aims to evaluate the efficacy and safety of bosakitug, with top line results expected in the second half of 2026 [1][2] Company Overview - Aclaris Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases [7] - The company has a robust R&D engine and a multi-stage portfolio of product candidates [7] Product Details - Bosakitug (ATI-045) is a humanized anti-TSLP monoclonal antibody that blocks TSLP's interaction with its receptor, preventing the release of proinflammatory cytokines [3] - It exhibits high affinity, potency, and a long residence time, potentially allowing for extended dosing intervals [3] Clinical Trial Information - The Phase 2 trial is randomized, double-blind, and placebo-controlled, involving approximately 90 patients [2] - Primary endpoint is the percent change in Eczema Area and Severity Index (EASI) at week 24, with secondary endpoints including various EASI responses and safety assessments [2] Atopic Dermatitis Context - Atopic dermatitis affects approximately 10 million children and 17 million adults in the U.S., with over 200 million affected worldwide [5] - The condition significantly impacts quality of life, with many patients experiencing moderate to severe symptoms [5] TSLP Significance - TSLP is a key cytokine in the Type 2 immune response, driving inflammation in allergic and inflammatory diseases [4] - It activates downstream targets involved in the inflammatory cascade, making it a relevant therapeutic target [4]

Core Insights - Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases [3] - The company will participate in a virtual fireside chat during the HC Wainwright "HCW@Home" series on May 16, 2025 [2] Company Overview - Aclaris Therapeutics is developing a pipeline of product candidates aimed at addressing the needs of 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] Event Details - The virtual fireside chat is scheduled for May 16, 2025, at 1:00 PM EDT, with a live and archived webcast available on the Aclaris website [2]