ABO21009 / AbolerIS Pharma - LARVOL DELTA

ABO21009-101: A placebo-controlled, single-blind, phase I study in healthy volunteers and patients with Rheumatoid Arthritis with ABO21009 (clinicaltrialsregister.eu) - P1 | N=78 | Recruiting | Sponsor: Aboleris Holdco

New P1 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

CD45RC Expression Correlates with Lymphocytic Infiltration in Salivary Glands: Proof-Of-Concept of Therapeutic and Biomarker Potential in Sjogren’s Disease (EULAR 2026) - "The anti-CD45RC mAb ABO21009 (Aboleris Pharma) is currently being evaluated in a placebo-controlled, single-blind, phase I clinical trial in healthy volunteers and patients with RA...Importantly, CD45RC expression in inflamed salivary gland is shown to be irrespective of autoantibody status. Altogether, our findings demonstrate the potential of CD45RC therapy in SjD and underscores its potential as a biomarker."

Biomarker • Candidiasis • Duchenne Muscular Dystrophy • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Graft versus Host Disease • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Muscular Dystrophy • Rheumatoid Arthritis • Sjogren's Syndrome • Transplant Rejection • CD20 • CD21 • SDC1

AbolerIS Pharma Announces First Patient Dosed in Part II of Phase 1 Study of ABO21009, a Novel Anti-CD45RC Antibody, for Rheumatoid Arthritis (GlobeNewswire) - "The ongoing Phase 1 study is a first-in-human, adaptive design, randomized, single-blind, placebo-controlled dose escalation study with single ascending dosing in healthy volunteers (part I), single ascending dosing in patients with RA (part II) and multiple ascending dosing in patients with RA (part III) to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of ABO21009....The Phase 1 study has been initiated in the Netherlands and is currently enrolling and dosing patients with RA under part II."

First-in-human • Trial status • Rheumatoid Arthritis

AbolerIS Pharma Announces First Cohort Dosed in Phase 1 Study of ABO21009, a Novel Anti-CD45RC Antibody, for Rheumatoid Arthritis (PRNewswire) - "AbolerIS Pharma...announced today that the first cohort of participants has been dosed with ABO21009, a humanized anti-CD45RC monoclonal antibody, in a first-in-human Phase 1 study for the treatment of Rheumatoid Arthritis (RA)....In part I, 24 patients are planned to be enrolled who will receive one of four single doses of ABO21009 and will be followed up for up to 10 weeks; the Phase 1 study has been initiated in the Netherlands, and is currently enrolling and dosing participants."

Trial status • Rheumatoid Arthritis