AbolerIS Pharma Begins Phase 1 Dosing of ABO21009 Antibody for Rheumatoid Arthritis

AbolerIS Pharma, a clinical-stage biopharmaceutical company based in Gosselies, Belgium, and Nantes, France, has initiated the first dosing of its novel humanized anti-CD45RC monoclonal antibody, ABO21009, in a Phase 1 study aimed at treating Rheumatoid Arthritis (RA). This marks a significant milestone for the company, which is focused on developing innovative treatments for autoimmune and inflammatory diseases.

ABO21009 is a pioneering treatment designed to meet the needs of RA patients who have not benefited from existing therapies, including anti-TNF treatments. Dr. Ann Meulemans, CEO of AbolerIS, emphasized the company’s innovative approach to targeting CD45RC, which positions them as a leader in the field of autoimmune and inflammatory disease treatment. She expressed excitement about transitioning the company to a clinical-stage entity with the potential of ABO21009 as a disease-modifying treatment.

The ongoing Phase 1 trial is structured as an adaptive, randomized, single-blind, placebo-controlled dose escalation study. It is divided into three parts: single ascending dosing in healthy individuals, single ascending dosing in RA patients, and multiple ascending dosing in RA patients. The trial's primary objectives include evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of ABO21009. The study, which began in the Netherlands, is currently enrolling and dosing participants.

Research highlights the importance of the CD45 protein, a transmembrane protein on hematopoietic cells, which plays a crucial role in regulating immune system functions. The C domain of CD45 protein isoforms is of global interest due to its unique role in immune modulation.

ABO21009 operates through a multi-faceted mechanism, selectively depleting pathogenic CD45RC-positive cells in the immune system that sustain the autoimmune response in RA. This selective depletion targets T, B, and NK cells, crucial components of the adaptive immune system, while preserving regulatory T cells. By doing so, ABO21009 aims to provide long-lasting efficacy, potentially leading to durable remission in RA patients, thereby enhancing patient experiences and reducing the side effects associated with current treatments.

Prof. Dirk Elewaut, Chairman of the Scientific Advisory Board at AbolerIS, expressed optimism about bringing this novel treatment to RA patients, highlighting the potential for improved quality of life and long-term remission. The promise of ABO21009 extends beyond RA, with plans to explore its efficacy in other conditions such as Sjögren’s Disease, Graft-versus-Host Disease, Inflammatory Bowel Disease, and Autoimmune Polyendocrinopathy-Candidiasis-Ectodermal Dystrophy, pending successful proof-of-concept in RA.

Ronald van Brempt, Chief Medical Officer of AbolerIS, reiterated the chronic and progressive nature of RA, emphasizing the significant impact on patients' lives. He expressed confidence in ABO21009’s potential to revolutionize treatment for RA and other autoimmune diseases. The rapid initiation of the trial in Europe was also highlighted as a testament to the dedication and efficiency of the AbolerIS team.

Overall, AbolerIS Pharma is advancing a promising new class of immunomodulators aimed at addressing significant unmet medical needs in autoimmune and inflammatory disorders. With ABO21009 at the forefront, the company is poised to make significant strides in improving the treatment landscape for these challenging conditions.