GHENT, BELGIUM--(Marketwired - Jun 12, 2013) - Ablynx (EURONEXT BRUSSELS: ABLX) today announced that it will have an oral and poster presentation on its novel anti-IL-6R Nanobody, ALX-0061, at the Annual European Congress of Rheumatology (EULAR), which takes place from 12 to 15 June 2013 in Madrid, Spain.

The oral presentation will demonstrate the strong efficacy and safety profile of ALX-0061 at the 24 week final analysis of the Phase II part of a combined Phase I/II study in patients with moderately to severely active rheumatoid arthritis on a stable background of methotrexate. The pooled data at week 24 show that treatment with ALX-0061 results in an ACR20 improvement of 84% and a 58% DAS28 remission. At all doses tested, ALX-0061 was well tolerated and clinically relevant neutropenia was absent as well as serious infections. Clinically significant signals in lipids were not observed and no anti-drug antibodies were detected.

The abstract "Twenty-four weeks of treatment with a novel anti-IL-6 receptor Nanobody resulted in 84% ACR20 improvement and 58% DAS28 remission in a Phase I/II study in RA" is available on the EULAR website at http://www.eular.org. (Abstract No. OP0043; Oral Presentation on Thursday, 13 June at 10.50h CET in Hall 4).

The poster presentation will include data from in vitro experiments that assessed the biological activity and affinity for both the soluble and membrane-bound IL-6-receptor of ALX-0061 as compared to tocilizumab (Actemra®). The in vitro results demonstrate the preferential inhibition of soluble IL-6R trans-signalling by ALX-0061 could provide superior therapeutic efficacy with a better side effect profile than tocilizumab.

The abstract "ALX-0061, an anti-IL-6R Nanobody for use in rheumatoid arthritis, demonstrates a different in vitro profile as compared to tocilizumab" is available on the EULAR website at http://www.eular.org. (Abstract No. FRI0021; Poster Presentation on Friday, 14 June at 11.45h CET in the Poster Area).

About ALX-0061
ALX-0061 targets the interleukin 6 pathway via its IL-6 receptor (IL-6R), which plays a fundamental role in the inflammation process in RA. ALX-0061 has been designed to become a best-in-class therapeutic. Its small size (26kD) should 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. ALX-0061 appears to benefit from the general Nanobody characteristic of having a very low immunogenic potential. ALX-0061 is a very robust and stable drug product that is already manufactured at a multi-thousand litre scale. It can be administered both intravenously and subcutaneously.