ATI-052 / Biosion, Aclaris - LARVOL DELTA

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