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GHENT, Belgium, 23 April 2014 - Ablynx[Euronext Brussels: ABLX]

today announced that it has started dose administration in healthy volunteers
in a Phase I clinical trial as part of the evaluation of a subcutaneous
formulation of its anti-IL-6R Nanobody®, ALX-0061, for the treatment of
inflammatory diseases, including rheumatoid arthritis (RA) and systemic lupus
erythematosus (SLE).

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
the Phase I bioavailability study with the subcutaneous formulation (sc
) of ALX-0061 and Phase II clinical development of ALX-0061sc
in RA and SLE, both of which are expected to start 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.

The Phase I study involves a single-centre, open-label trial to evaluate the
bioavailability of ALX-0061 aftersc
and intravenous (iv
) administration in healthy volunteers. In addition, the study will assess the
pharmacodynamics, safety, tolerability and immunogenicity of singlesc
doses of ALX-0061 in healthy subjects. The trial is expected to recruit 70
subjects who will each receive a single dose of ALX-0061, either as asc
injection (50 mg, 150 mg or 300 mg dose) oriv
infusion (50 mg or 300 mg dose).

Dr Edwin Moses, CEO of Ablynx, commented:

"We are pleased that our collaboration with AbbVie is progressing well. With
the start of the bioavailability study, we are on track for the further
development of ALX-0061 as agreed with our partner. Results of the study are
anticipated by the end of 2014, with the goal to start Phase II clinical
development of ALX-0061sc
in both RA and SLE patients in 2015."

About ALX-0061

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 thein 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.

About RA and SLE

RA is characterised by chronic and progressive joint inflammation that
typically results in permanent, debilitating tissue damage, which is further
compounded by joint deformation. The condition is associated with lower
quality of life, premature death, disability, and unemployment. It is
estimated that up to 1 percent of the adult population worldwide suffer from

SLE is a complex, multi-organ, autoimmune disorder characterised by the
production of pathogenic autoantibodies and tissue deposition of immune
complexes, which result in widespread tissue damage. Although the etiology of
SLE is not fully understood, multiple genetic, environmental, and hormonal
factors have been implicated in its development. The disease displays a broad
variety of symptoms and highly variable clinical features, including
systemic, cutaneous, renal, musculoskeletal, and haematological
manifestations. Approximately 5 million people worldwide suffer from a form
of lupus and 90 percent of people diagnosed are women.

About Ablynx

Ablynxis a biopharmaceutical company engaged in the discovery and development
ofNanobodies®, 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 approximately30 programmes in the pipelineand seven Nanobodies in
clinical development. Ablynx has on-going research collaborations and
significant partnerships with major pharmaceutical companies including
AbbVie, Boehringer Ingelheim, Eddingpharm, Merck&Co, Merck Serono and
Novartis. The Company is headquartered in Ghent, Belgium.

More information can be found onwww.ablynx.com.

For more information, please contact


Dr Edwin Moses
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

Ablynx media relations
Consilium Strategic Communications:

Mary-Jane Elliott, Amber Bielecka, Lindsey Neville
t: +44 203 709 5700
e: ablynx@consilium-comms.com

pdf version of the press release


This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Ablynx via Globenewswire


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