#Belgium #rheumatoid arthritis #ABO21009 #Gosselies #AbolerIS

AbolerIS Pharma Advances Treatment for Rheumatoid Arthritis

AbolerIS Pharma, a clinical-stage biopharmaceutical company, has made a significant stride in the battle against rheumatoid arthritis (RA). On January 8, 2026, the company announced that the first patient has been dosed with its innovative anti-CD45RC antibody, ABO21009, in an ongoing Phase 1 clinical trial. This pivotal moment marks the transition from the assessment of healthy volunteers to actual patient dosing, reflecting the company's commitment to developing new therapies for autoimmune diseases.

Understanding ABO21009

ABO21009 is a humanized monoclonal antibody designed to tackle the underlying mechanisms of autoimmune diseases, specifically rheumatoid arthritis. It aims to deplete the pathogenic Effector T and B cells while promoting the growth of Regulatory T cells to restore immune balance. By selectively targeting CD45RC-positive cells, which are crucial for sustaining autoimmune responses, ABO21009 offers a novel approach that could potentially transform RA treatment outcomes.

Dr. Ann Meulemans, the CEO of AbolerIS Pharma, emphasized the importance of this milestone, stating, "Dosing the first patient in our Phase 1 study is a major step forward for AbolerIS and our mission to redefine autoimmune treatment options." This new therapy addresses a significant unmet need, as many patients with RA continue to experience symptoms despite existing treatments.

Clinical Trial Overview

The Phase 1 study is a comprehensive, adaptive, randomized, single-blind, placebo-controlled trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ABO21009. The trial is structured in three parts: initial dosing in healthy volunteers, followed by a single ascending dose in RA patients, and finally, multiple ascending doses in RA patients. The study began in the Netherlands with an initial enrollment of 24 volunteers in Part I, who will be followed for up to 10 weeks.

Part II has now commenced, focusing on patients with RA, with dosing ongoing. The results from this study could substantiate the clinical proof-of-concept for ABO21009, potentially leading to broader applications in treating other autoimmune diseases.

The Mechanism of Action

ABO21009 is unique in its multi-pronged mechanism of action, effortlessly depleting CD45RC-positive cells while spurring Regulatory T cells to exert their immunosuppressive effects. This dual action aims to not just treat RA but also achieve long-lasting, durable remission, thereby enhancing the quality of life for patients and minimizing side effects associated with current treatment options.

According to Dr. Ronald Van Brempt, the Chief Medical Officer, "ABO21009 is the first antibody of its class, representing a groundbreaking strategy to reset the immune system and restore tolerance. By targeting the core drivers of RA that hinder patients from achieving remission, our approach is poised to revolutionize patient care."

Future Prospects

AbolerIS intends to expand the development of ABO21009 beyond RA to include other inflammatory disorders like inflammatory bowel disease and organ transplantation, contingent on clinical success. The company, headquartered in Gosselies, Belgium, and Nantes, France, is bolstered by a robust investor network comprising Newton Biocapital and other notable entities.

In conclusion, AbolerIS Pharma's efforts in advancing ABO21009 represent a beacon of hope for RA patients who currently face limited therapeutic options. With the commencement of this Phase 1 clinical trial, the company is one step closer to potentially offering effective, long-lasting solutions to those living with debilitating conditions caused by autoimmune responses. For further updates and detailed information about the ABO21009 trial, visit AbolerIS Pharma.