ATI-052 / Biosion, Aclaris - LARVOL DELTA

Late Breaking Abstract - Pharmacokinetics and pharmacodynamics of ATI-052, a novel bispecific anti-TSLP/IL-4Ra antibody: results from a first-in-human Phase 1a single and multiple ascending dose study (ERS 2026) - "CONCLUSIONS ATI-052 was well tolerated.The estimated half-life of approximately 45 days, combined with dose-proportional exposure and complete, sustained inhibition of both the TSLP and IL-4/IL-13 signaling axes, supports the potential for extended dosing intervals of up to every three months. Phase 1b proof-of-concept trials of ATI-052 in asthma (GINA steps 2-4) and atopic dermatitis (EASI > 21) are ongoing."

Bispecific • First-in-human • Late-breaking abstract • P1 data • PK/PD data • Asthma • Atopic Dermatitis • Conjunctivitis • Dermatitis • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology • Respiratory Diseases • IL13 • IL4 • IL4R • TSLP

Second Quarter 2026 Highlights, Recent Updates and Upcoming Catalysts (Investing News Network (INN)) - "Reaffirmed Expectation of Top Line Results in the Second Half of 2026 from Two Ongoing Phase 1b POC Trials of ATI-052: ATI-052 is being assessed in POC trials in both atopic dermatitis (AD) and asthma...Confirmed Intent to Initiate a Phase 2b Program Encompassing Asthma and AD with ATI-052 in the Fourth Quarter of 2026....On Track for Expected Fourth Quarter 2026 Readout of Top Line Results from Phase 2 Trial of Investigational Anti-TSLP Monoclonal Antibody Bosakitug."

New P2b trial • P1 data • P2 data • Asthma • Atopic Dermatitis • Immunology

Aclaris Therapeutics Maps Busy Pipeline Calendar, Plans Phase 2 Asthma Trial for ATI-052 (TradingView) - "Aclaris is running two Phase 1b studies of ATI-052, a bispecific antibody targeting TSLP and IL-4R, with data expected in the second half of the year...The atopic dermatitis Phase 1b study is placebo-controlled and designed to look for signs of additive or synergistic benefit...Aclaris has already decided to move ATI-052 into a Phase 2 asthma study, with the trial expected to start in the fourth quarter."

New P2 trial • P1 data • Asthma • Atopic Dermatitis

ATI-052-ASTH-101: A Phase 1b, Double-Blind Study to Investigate Safety, Tolerability, Pharmacokinetics, Efficacy, and Pharmacodynamics of Single Dose of ATI-052 in Participants with Mild to Moderate Asthma (clinicaltrialsregister.eu) - P1 | N=10 | Recruiting | Sponsor: Aclaris Therapeutics Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

First Quarter 2026 Highlights and Recent Updates (GlobeNewswire) - "Confirmed Expectation of Top Line Results in the Second Half of 2026 from Two Ongoing Phase 1b Proof-of-Concept (POC) Trials of ATI-052...Given the data developed to date and its unique mechanism of action, the Company announced its intent to initiate a Phase 2b program with ATI-052, initially targeting asthma, in the fourth quarter of 2026....Completed Enrollment in Phase 2 Trial of Investigational Anti-TSLP Monoclonal Antibody Bosakitug; Confirmed Expectation of Top Line Results in the Fourth Quarter of 2026."

New P2b trial • P1 data • P2 data • Asthma • Atopic Dermatitis • Immunology

Ongoing and Future Clinical Trials (Investing News Network (INN)) - "Enrollment is ongoing in both trials, and top line results from both are expected in the second half of 2026...Given the results observed to date and its mechanism of action targeting TSLP as well as effects of IL-4 and IL-13 through blockade of the shared receptor IL-4Rα, the Company announced its intent to initiate a Phase 2b program with ATI-052, initially targeting asthma, in the fourth quarter of 2026."

New P2b trial • P1 data • Asthma • Atopic Dermatitis • Immunology

Full Top Line Phase 1a SAD/MAD Results (Investing News Network (INN)) - "ATI-052 exhibited a potential best-in-class pharmacokinetic (PK) profile, including an estimated half-life of approximately 45 days. Dose proportional PK was observed across the pharmacologic dose range, including dose proportional increases in Cmax (maximum peak concentration) and AUC (area under the curve; a measure representing total systemic exposure)...The combination of the strong and sustained PK duration and PD effect supports the potential for up to every three-month dosing; No impact of anti-drug antibodies (ADA) on PK or PD has been observed in this trial; ATI-052 was well tolerated and demonstrated a favorable safety profile across all SAD and MAD cohorts, consistent with the interim results; no safety signals including conjunctivitis were observed."

P1 data • PK/PD data • Immunology

ATI-052-ASTH-101: A Phase 1b, Double-Blind Study to Investigate Safety, Tolerability, Pharmacokinetics, Efficacy, and Pharmacodynamics of Single Dose of ATI-052 in Participants with Mild to Moderate Asthma (clinicaltrialsregister.eu) - P1 | N=10 | Not yet recruiting | Sponsor: Aclaris Therapeutics Inc.

New P1 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Aclaris Therapeutics Touts ATI-052 Potential for 3-Month Dosing, More Phase 1 Data Incoming (MarketBeat) - "Aclaris says lead biologic ATI-052 shows potential for three-month dosing based on SAD/MAD data and will report two–three additional cohorts later this month while running phase 1b studies in severe atopic dermatitis and asthma with a phase 2b asthma study planned around year‑end/turn of the year."

New P2b trial • P1 data • Trial status • Asthma • Atopic Dermatitis • Immunology

Provided Positive Interim Results of Phase 1a Single (SAD) and Multiple Ascending Dose (MAD) Trial of Investigational Bispecific Anti-TSLP/IL-4Rα Antibody ATI-052 (GlobeNewswire) - "Complete Top Line Results from SAD and MAD Cohorts Expected in the Second Quarter of 2026."

P1 data • Asthma • Atopic Dermatitis • Immunology

Aclaris Therapeutics Initiates Phase 1b Proof-of-Concept Trial in Patients with Asthma with its Novel Bispecific Anti-TSLP/IL-4Rα Antibody ATI-052 (GlobeNewswire) - "The randomized (3:1), double-blind, placebo-controlled Phase 1b POC trial will evaluate the safety, tolerability, and efficacy of ATI-052 compared to placebo in approximately 16 patients with asthma on GINA (Global Initiative for Asthma) steps 2-4 treatment prior to screening....Top line results from this trial and the ongoing Phase 1b POC trial in AD are expected in the second half of 2026."

P1 data • Trial status • Asthma • Atopic Dermatitis • Immunology

Planning is ongoing for a Phase 2b program encompassing asthma and atopic dermatitis as potential first indications (GlobeNewswire) - "The Company expects to initiate this program in the second half of 2026."

New P2b trial • Asthma • Atopic Dermatitis • Immunology

Aclaris Therapeutics Initiates Phase 1b Proof-of-Concept Trial in Atopic Dermatitis (AD) with Its Novel Bispecific Antibody ATI-052 (GlobeNewswire) - "This randomized (3:1), blinded, placebo-controlled Phase 1b POC trial will evaluate the safety and tolerability of ATI-052 compared to placebo in patients with moderate-to-severe AD....Aclaris also expects to initiate a Phase 1b POC trial in asthma in the first quarter of 2026. Top line results from both POC trials are expected in the second half of 2026."

New P1 trial • P1 data • Trial status • Asthma • Atopic Dermatitis • Immunology

Biologics: Antibody Franchise (GlobeNewswire) - "Top Line Results Expected in Early 2026 from Phase 1a Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Portion of Ongoing Phase 1a/1b Program of Investigational Bispecific Anti-TSLP/IL-4R Antibody ATI-052...Following completion of the Phase 1a SAD/MAD portion, the Company expects to initiate these Phase 1b POC studies in the first half of 2026, with top line results expected in the second half of 2026."

New P1 trial • P1 data • Asthma • Atopic Dermatitis • Immunology

Second Quarter 2025 and Year-to-Date 2025 (Aclaris Press Release) - "Research and development (R&D) expenses were $11.4 million and $23.0 million for the quarter and six months ended June 30, 2025, respectively, compared to $8.8 million and $18.6 million for the corresponding prior year periods. The increases were primarily driven by product candidate manufacturing costs, preclinical development activities, and clinical development expenses associated with the Phase 2 trial in AD for bosakitug and the Phase 1a/1b program for ATI-052. For the six-month comparison period, clinical development expenses associated with the Phase 2a trial in AD for ATI-2138 also contributed to the increase."

Commercial • Alopecia • Atopic Dermatitis

Aclaris Therapeutics Initiates Phase 1a/1b Program for its Novel Bispecific Antibody ATI-052 (GlobeNewswire) - "Aclaris Therapeutics...announced that it has initiated a placebo-controlled Phase 1a/1b program for ATI-052, the Company’s potential best-in-class investigational bispecific anti-TSLP/IL-4R antibody. The program will consist of a Phase 1a single and multiple ascending dose (SAD/MAD) portion in healthy volunteers, followed by an expected Phase 1b proof of concept portion....'We expect to complete the Phase 1a SAD/MAD portion by year-end 2025 and provide top line results in early 2026, followed by the top line results from the Phase 1b portion in the second half of 2026.'"

P1 data • Trial status • Immunology

Aclaris Therapeutics Secures U.S. Food and Drug Administration IND Clearance for ATI-052, Enabling Advancement of its Novel Bispecific Anti-TSLP/IL-4R Investigational Antibody (GlobeNewswire) - "Aclaris Therapeutics, Inc...announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase 1a/1b clinical trial of ATI-052, a potential best-in-class bispecific anti-TSLP/IL-4R monoclonal antibody....The randomized, blinded, placebo-controlled, Phase 1a/1b clinical trial will evaluate single and multiple ascending doses of ATI-052 followed by a proof-of-concept portion in an undisclosed indication. The Company expects to initiate the trial in the second quarter of 2025."

IND • New P1 trial • Immunology

Aclaris Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides a Corporate Update (GlobeNewswire) - "Confirmed Expectation of Phase 2 Data in the First Half of 2025 for Bosakitug in Chinese Patients with Certain Pulmonary Disorders:..Data from trials in severe asthma and CRSwNP expected in first half of 2025 to inform internal development programs. Initiated Clinical Trial Activities for a Phase 2b Trial of Bosakitug in Atopic Dermatitis (AD); Enrollment Expected to Begin in the First Half of 2025...Confirmed Expectation of Top Line Results in the First Half of 2025 for Phase 2a Trial in AD of ATI-2138, an Investigational Oral Covalent ITK/JAK3 Inhibitor...Announced Plan to File an Investigational New Drug (IND) Application for ATI-052 in the First Quarter of 2025..."

IND • New P2b trial • P2 data • Asthma • Chronic Obstructive Pulmonary Disease • Chronic Rhinosinusitis With Nasal Polyps • Pulmonary Disease • Ulcerative Colitis

Biosion Announces Exclusive, Global License Agreement with Aclaris Therapeutics on two potential First-in-Class and Best-in-Class Immunology Assets (PRNewswire) - "Biosion, Inc...today announced that it has entered into an exclusive license agreement with Aclaris Therapeutics...for worldwide rights (excluding Greater China) to BSI-045B, a potential First-in-class, clinical-stage, novel anti-TSLP monoclonal antibody, and BSI-502, a potential best-in-class, pre-clinical stage, novel bispecific antibody that is directed against both TSLP and IL4R. Under the terms of the agreement, Biosion shall receive over $40 million cash payment as upfront license fee and reimbursement for certain development costs & drug product materials. Biosion shall also receive 19.9% shares of common stock of Aclaris Therapeutics. Additional regulatory and sales milestone payments exceed $900M with tiered low-to-mid single digit royalty based upon a percentage of annual net sales."

Licensing / partnership • Asthma • Atopic Dermatitis • Immunology