Ablynx to Present Rheumatoid Arthritis Data at 2012 American

Ablynx to Present Rheumatoid Arthritis Data at 2012 American College
of Rheumatology Annual Meeting 
GHENT, BELGIUM -- (Marketwire) -- 11/09/12 --   Ablynx (EURONEXT
BRUSSELS: ABLX) today announced that it will present data from two
Nanobody(R)-based products in rheumatoid arthritis (RA) at the annual
meeting of the American College of Rheumatology (ACR) from 10-14
November in Washington D.C., USA. The poster presentations will be
based on the outcome of pre-clinical and clinical studies that have
previously been disclosed. 
Ablynx will have three poster sessions including two posters on its
novel IL-6R Nanobody, ALX-0061, and one poster on its novel anti-TNFa
Nanobody, ozoralizumab (ATN-103).  
ALX-0061 is a bi-specific IL-6R targeting Nanobody with monovalent
binding to IL-6R and human serum albumin. Translational modelling
studies resulted in a novel first-in-human design that combined a
single-ascending dose, a multiple ascending dose and clinical POC
using pharmacokinetics, biomarker and early clinical read outs as
decision tools. Earlier reported results from the 12 week interim
analysis of the Phase I/II study demonstrate that ALX-0061 has the
potential to become a best-in-class IL-6R inhibitor in RA with a
strong efficacy profile based on a 80% ACR20 response, a 60%
DAS28-CRP remission rate, and a fast onset of DAS28-CRP remission;
and an excellent safety profile with no serious infections, no
decrease in neutrophils, no clinically significant increases in liver
enzymes and no increases in lipid levels (cholesterol and LDL) being
Ozoralizumab, ATN-103, a novel TNFa inhibitor, is a trivalent,
bi-specific Nanobody that potently neutralises TNF and binds to human
serum albumin to increase its in vivo half-life. The results from the
Phase II open-label extension study demonstrated that ozoralizumab
enables highly effective and well-tolerated individualised treatment.
The specific molecular features of Nanobodies, including their small
size, low immunogenic potential and manufacturability, contributed to
the desired outcome, with the majority of patients showing marked
improvement in their disease activity. Moreover, the once-induced
remission could be maintained at doses less than 80mg monthly. This
treatment approach could be beneficial to 
patients and minimise
treatment costs.  
Details on the poster sessions
 Abstract/poster #336: Pre-clinical
development of ALX-0061, an anti-IL-6R Nanobody for therapeutic use
in rheumatoid arthritis with a high in vitro affinity and potency and
a competitive in vivo pharmacological profile - 11 November  
Abstract/poster #1307: Anti-IL-6 receptor Nanobody (ALX-0061)
seamless "first-in-human" Phase I/II POC study in patients with
active RA on stable MTX treatment- 12 November
#1311: A novel individualised treatment approach in open-label
extension study of ozoralizumab (ATN-103) in subjects with rheumatoid
arthritis on a background of methotrexate - 12 November  
About Ablynx
 Ablynx is a biopharmaceutical company engaged in the
discovery and development of Nanobodies(R), a novel class of
therapeutic proteins based on single-domain antibody fragments, for a
range of serious human diseases, including inflammation, haematology,
oncology and pulmonary disease. Today, the Company has approximately
25 programmes in the pipeline and seven Nanobodies at clinical
development stage. Ablynx has ongoing research collaborations and
significant partnerships with major pharmaceutical companies
including Boehringer Ingelheim, Merck KGaA, Novartis and Merck & Co.
The Company is headquartered in Ghent, Belgium. More information can
be found on www.ablynx.com. 
press release in pdf: http://hugin.info/137912/R/1656461/535559.pdf  
For more information, please contact
Dr. Edwin Moses
Chairman and CEO
t: +32 (0)9 262 00 07
m: +44 (0)7771 954 193 
+32 (0)473 39 50 68
e: edwin.moses@ablynx.com 
Marieke Vermeersch
Associate Director Investor Relations
t: +32 (0)9 262 00 82
m: +32 (0)479 49 06 03 
e: marieke.vermeersch@ablynx.com 
Follow us on Twitter @AblynxABLX 
Mary-Jane Elliott, Amber Bielecka, Claire Dickinson
t: +44 207 920 2330
e: ablynx@mcomgroup.com 
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