AbolerIS Pharma has dosed the Phase I study’s first cohort subjects with its humanised anti-CD45 receptor-like protein C (CD45RC) monoclonal antibody, ABO21009, aimed at treating rheumatoid arthritis (RA).
The antibody is tailored for RA patients who have not responded well to existing treatments, including anti-tumour necrosis factor (TNF) therapies.
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The first-in-human, adaptive design, randomised, single-blind, dose escalation placebo-controlled trial comprises three parts: Part I with single ascending dosing in healthy volunteers, with Part II and Part III focusing on single ascending dosing and multiple ascending dosing in RA patients, respectively to assess tolerability, pharmacodynamics, pharmacokinetics, and safety of the therapy.
Part I plans to enrol 24 subjects who will be given one of four single doses of the antibody and will undergo a up to ten-week follow-up period.
The trial has commenced in the Netherlands, and the subject enrolment and dosing are currently underway.
AbolerIS Pharma CEO Dr Ann Meulemans said: “AbolerIS is at the forefront of innovation in autoimmune and inflammatory diseases with our approach in targeting CD45RC and we are thrilled to transition to a clinical-stage company.
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By GlobalData“ABO21009 is the first antibody of its class to enter clinical trials in Europe and we believe it has great potential as a disease-modifying treatment for RA due to its multi-pronged mechanism of action. This year we are focused on the determination of safety, target engagement and dose range finding in patients suffering from RA.”
AbolerIS Pharma noted that ABO21009 stems from the company’s immunomodulatory approach for treating inflammatory and autoimmune conditions.
The antibody’s mechanism of action involves selective depletion of CD45RC-positive cells, which actively sustain the autoimmune response in RA.
These cells are said to be part of the T-, B-, and NK-cell compartments of the adaptive immune system.
Moreover, the antibody claims to spare regulatory T cells, which muffles ongoing and upcoming autoimmune activity within the adaptive immune system.
Upon achieving clinical proof-of-concept in RA, the company plans to expand its development to other autoimmune conditions.
AbolerIS Pharma is based in Belgium and France.
