ABLYNX STARTS ADDITIONAL PHASE I STUDIES WITH ANTI-RSV NANOBODY ALX-0171
(Thomson Reuters ONE) -
GHENT, Belgium, 4 July 2013 - Ablynx (Euronext Brussels: ABLX) today announced
that it has initiated two additional Phase I studies with its anti-RSV
Nanobody®, ALX-0171, with the goal of commencing paediatric development during
the second half of 2014. Respiratory Syncytial Virus (RSV) is a respiratory
virus that infects the lungs and respiratory tract and is the most common cause
of bronchiolitis and pneumonia in children under one year of age.
The additional Phase I studies are being performed to determine the appropriate
dosing regimen in the subsequent paediatric development of the Nanobody, and
will include a safety study in adults with hyper-responsive airways and a local
and systemic pharmacokinetic (PK) study in healthy volunteers. The results of
both Phase I studies are expected during the first half of 2014.
Bronchoconstriction (narrowing of the airways in the lungs) induced by ALX-0171
inhalation has not been observed in healthy adult volunteers. A phase I study in
adults with hyper-responsive airways will further evaluate the potential
occurrence of bronchoconstriction following single escalating doses of ALX-0171
as well as repeated inhalation of ALX-0171. If indicated, the prevention or
reversion of bronchoconstriction, involving the administration of a standard
bronchodilator already often used in the management of RSV infection, will be
assessed as well. This single-centre, open-label study is expected to recruit
24 subjects.
In addition, Ablynx has initiated a Phase I study in healthy male volunteers to
assess the local and systemic pharmacokinetics of single and repeated daily
inhalations of ALX-0171, and the systemic pharmacokinetics of a single
intravenous (iv) injection of ALX-0171. This Phase I study is expected to
recruit 41 subjects and will examine doses of 0.3 mg/kg (iv) and fixed doses of
200 mg (inhalation).
Dr Edwin Moses, Chairman and CEO of Ablynx, commented:
"We are very pleased to move forward with our first inhaled Nanobody, which has
the potential to become a first-in-class therapeutic to treat RSV infection in
young children, an area with high unmet medical need. These additional studies
will provide us with an appropriate clinical package for ALX-0171 that should
allow the start of a Phase II study in infants during the second half of 2014."
About ALX-0171
Ablynx's innovative technology platform, which enables unique and flexible drug
formatting, resulted in the creation of a trivalent Nanobody, ALX-0171. The
physical robustness allows fast delivery directly into the lungs, i.e. the site
of infection, via nebulisation. The trivalent structure allows for increased
activity at the target, which enables neutralisation of virus replication in the
lungs. As such, Ablynx was able to generate a therapeutic product that works
specifically at the site of infection. In contrast, it is very difficult to
nebulise classical monoclonal antibodies. As a result, these can currently only
be administered systemically and it has proved very difficult to deliver
sufficient antibody to the infection site to achieve a therapeutic effect. A
Phase I safety study in healthy male volunteers demonstrated that single and
multiple inhalations of the Nanobody were well tolerated and no dose-limiting
toxicity or treatment emergent immunogenicity was observed. Furthermore, ALX-
0171 had no clinically relevant effect on lung function, no signs of
bronchoconstriction were observed, and the Nanobody had the opportunity for
once-daily dosing.
About Respiratory Syncytial Virus (RSV)
RSV remains the primary reason for infant hospitalisation and virus associated
deaths in infants, hence the high need for an effective and specific anti-RSV
therapeutic drug. It is estimated that there are more than 300,000 child
hospitalisations per 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 mostly symptomatic.
About Ablynx
Ablynx is a biopharmaceutical company engaged in the discovery and development
of Nanobodies(®), 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 six Nanobodies at clinical
development stage. Ablynx has on-going research collaborations and significant
partnerships with major pharmaceutical companies including Boehringer Ingelheim,
Merck Serono, Novartis and Merck & Co. The Company is headquartered in Ghent,
Belgium. More information can be found on www.ablynx.com.
For more information, please contact
Ablynx:
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(at)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(at)ablynx.com
Follow us on Twitter (at)AblynxABLX
M:Communications:
Mary-Jane Elliott, Amber Bielecka, Claire Dickinson
t: +44 207 920 2330
e: ablynx(at)mcomgroup.com
press release in pdf format:
http://hugin.info/137912/R/1714016/569085.pdf
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(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Ablynx via Thomson Reuters ONE
[HUG#1714016]
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