Clinical Trials

Date: 2014-06-10

Type of information: Presentation of results at a congress

phase: 1-2

Announcement: presentation of results at the Annual European Congress of Rheumatology (EULAR)

Company: Ablynx (Belgium)

Product: ALX-0061

Action mechanism: ALX-0061 targets the interleukin-6 pathway via its IL-6 receptor (IL-6R), which plays a key role in the inflammation process in RA. ALX-0061 has been designed to become a best-in-class therapeutic. Its small size (26kD) may potentially allow ALX-0061 to penetrate more effectively into tissues. The potent, monovalent interaction of the molecule with its target reduces the possibility of off-target effects. Its binding to human serum albumin prolongs the in vivo half-life of the product and can lead to improved trafficking to areas of inflammation. The Nanobody has a very strong affinity for soluble IL-6R which should ensure fast target engagement and could result in a fast onset of effect. In September 2013, Ablynx and AbbVie entered into a global license agreement, worth up to US$840 million plus double-digit royalties, to develop and commercialise ALX-0061. As part of the agreement, Ablynx is responsible for Phase I and Phase II clinical development of subcutaneous (sc) ALX-0061 in RA and systemic lupus erythematosus (SLE). Ablynx has recently initiated a Phase I bioavailability study with the sc formulation of ALX-0061.

Disease: rheumatoid arthritis

Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases

Country:

Trial details:

Latest news:

• • On June 10, 2014, Ablynx announced that it will present additional positive data on its anti-IL-6R Nanobody®, ALX-0061, at the Annual European Congress of Rheumatology (EULAR), which is taking place from 11 to 14 June in Paris, France. The poster presentation includes results from a post-hoc analysis of data collected in a 24-week combined Phase I/II study in patients with moderately-to-severely active rheumatoid arthritis on a stable background of methotrexate. These data show that, in patients with established rheumatoid arthritis, intravenously administered ALX-0061 induces and maintains remission as assessed by both DAS28 criteria and the more stringent Boolean remission definition. Control of disease activity with ALX-0061 results in regaining normal physical function, supporting treat-to-target management of RA as reflected in the EULAR recommendations. The abstract is entilted \"Impact of Clinical Remission on Physical Function in Patients with Rheumatoid Arthritis Treated with ALX-0061: Post-hoc Analysis of Phase I/II Data\". Results of the study are anticipated by the end of 2014, with the goal to start Phase II clinical development of ALX-0061 sc in both RA and SLE patients in 2015. Upon the achievement of pre-defined Phase II success criteria, AbbVie will exercise its right to in-license ALX-0061 and be responsible for subsequent Phase III clinical development and commercialisation.

Is general: Yes