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. |
