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On track to start first paediatric study in Winter 2014

GHENT, Belgium, 6 May 2014
-Ablynx[Euronext Brussels: ABLX]

today announced that it has obtained positive results from two additional
Phase I studies, utilising its wholly-owned anti-RSV Nanobody®(ALX-0171)
designed for the treatment of Respiratory Syncytial Viral (RSV) infections,
following on from the successful Phase I study reported in September 2012.
ALX-0171 is Ablynx's first inhaled Nanobody and was administered to adults
via a nebulizer in a safety study and in a pharmacokinetic (PK) study.

RSV is a virus which infects the respiratory tract. It is the most common
cause of bronchiolitis and pneumonia in children under one year of age.
ALX-0171 is a potential first-in-class therapeutic for RSV, an infection for
which there is no widely accepted anti-viral treatment currently available.
Ablynx expects to commence a proof-of-concept study in the target paediatric
population with ALX-0171 in Q4 2014 with data due in 2015.

The safety study was performed in 24 adults with hyper-reactive airways using
single escalating doses of ALX-0171, ranging from 2 to 200 mg, as well as
repeated daily inhalation of either 140 or 200 mg of ALX-0171 for 5 days, to
determine the occurrence and reversibility of bronchoconstriction(narrowing
of the airways in the lungs). Bronchoconstriction may be induced by
inhalation therapy and therefore it is important in the evaluation of any
such therapy to determine whether bronchoconstriction can be reversed and/or
prevented by standard bronchodilators.

The data generated from the safety study demonstrated that administration of
the Nanobody was well-tolerated. As expected, some subjects experienced
bronchoconstriction but the extent of this was limited (mild) and did not
show any clear relationship to dosing. The event could immediately be
reversed and subsequently prevented by the use of standard bronchodilators
(Beta2-agonists). Guidance can therefore be given in future trials on how to
treat bronchoconstriction in the event that it occurs after treatment with

The PK study was performed in 41 healthy adult volunteers and investigated the
concentration of the Nanobody locally (in the bronchial and alveolar space)
and/or systemically when administered by oral inhalation or intravenous
administration. Direct measurement of ALX-0171 levels in the lung
demonstrated very rapid attainment of clinically relevant levels after
once-daily administration by inhalation. The lung exposure could be
correlated with the systemic exposure and this, together with the desired
target concentration and further PK modelling, will allow determination of
the dose expected to be effective in infants.

Results from the PK study reconfirmed that ALX-0171 was well tolerated, as
reported after the initial first-in-human study, at concentrations in the
lung which are well above the levels that will be targeted in the forthcoming
paediatric studies.

Commenting on the successful completion of the two studies, Dr Edwin Moses,
CEO of Ablynx, said:

"ALX-0171 has been specifically designed to be delivered directly to the site
of infection via nebulization in order to achieve fast onset of action and
high local concentration levels. ALX-0171 has now been safely administered to
more than 100 adults and the data generated in all three Phase I studies
support the start of the first-in-infant study later this year. We expect
potential proof-of-concept data in infants in 2015. Currently, there is no
widely used therapeutic specifically indicated for RSV and generally only
supportive therapies are used in the management of this viral infection. The
infection seriously affects the very young and other at-risk groups, and
results in a significant burden on the healthcare system. We believe that
ALX-0171 could potentially become a transformational first-in-class treatment
for RSV infections."

About Respiratory Syncytial Virus (RSV)

RSV remains the primary reason for infant hospitalisation and virus associated
deaths in infants, hence the need for an effective and specific anti-RSV
therapeutic drug. It is estimated that there are more than 300,000 children
hospitalized each year in the seven major pharmaceutical markets and the
reported infection rate is 70-80% in children under two years of age. In
addition, RSV infection is a significant cause of pulmonary disease in
transplant patients, immune-compromised subjects and the elderly. Current
treatment of patients infected with RSV is primarily focussed on symptomatic

About ALX-0171

ALX-0171 is a trivalent, non-half-life extended Nanobody that specifically
binds to and neutralises RSV. ALX-0171, designed and wholly owned by Ablynx,
has first-in-class potential as there is no widely used therapeutic
specifically indicated for RSV treatment. It is the first Nanobody product
developed for delivery directly into the lungs by inhalation.

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, 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 format 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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