Additional data on ALX-0061 nanobody to be presented

Ablynx has 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 takes place from 11 to 14 June in Paris, France.

The poster presentation will include 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 (RA) on a stable background of methotrexate. The data shows that, in patients with established RA, 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.

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. It 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.

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