ABLYNX ANNOUNCES POSITIVE PHASE I RESULTS FOR SUBCUTANEOUS ADMINISTRATION OF ITS ANTI-THROMBOTIC NANOBODY® (ALX-0681)

GHENT, BELGIUM--(Marketwire - August 18, 2009) - Ablynx [Euronext Brussels: ABLX]
today announced the positive results from its double-
blind,
randomized, placebo-controlled, single and multiple dose Phase
I
study with ALX-0681, a subcutaneous formulation of its
novel
anti-thrombotic Nanobody® that selectively targets von
Willebrand
factor (vWF). The positive Phase I data support the progression
of
ALX-0681 towards Phase II testing in patients with
thrombotic
thrombocytopenic purpura (TTP), expected to commence in Q2 2010.
The
anti-vWF Nanobody® received orphan drug designation by the EMEA
and
the FDA for the treatment of TTP in May this year.

The Phase I study was designed to investigate the
safety,
tolerability, pharmacokinetics (PK) and pharmacodynamics (PD)
of
single and repeated subcutaneous administrations of ALX-0681. A
total
of 36 healthy volunteers were treated with either single
subcutaneous
doses of ALX-0681 ranging from 2mg to 16mg or daily 10
mg
subcutaneous injections for 7 or 14 days.

All administrations of ALX-0681 were well tolerated and did
not
result in clinically significant adverse events. No signs of
local
intolerance or clinically significant bleeding events occurred and
no
evidence of immunogenicity was observed for 45 days after
completion
of treatment.

The desired biological effect, determined by complete inhibition
of a
biomarker, was achieved for more than 14 days with daily
injections
of 10mg of the anti-vWF Nanobody® confirming the biological
efficacy
of ALX-0681. The PD parameters for coagulation Factor VIII and
vWF
showed a fast and reversible decrease compared to pre-dose
values,
with normalisation between 24 and 72 hours after the
last
administration, depending on dose. The PK profile remained
unchanged
after multiple administrations, confirming the
favourable
pharmacological behaviour of ALX-0681.

ALX-0681 is being developed for the treatment of patients with
TTP.
It is also anticipated that the subcutaneous administration
of
ALX-0681 will provide access to additional patient
populations
suffering from unwanted blood-clot formation, such as those
with
acute coronary syndrome (ACS), which are not currently addressed
by
the intravenous administration of ALX-0081.

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