Ablynx dans le vert ...Lancement de deux études de phase 1 Additionnel, la raison du vert d'aujourd'hui?
article repris sur le site de la société :
ABLYNX STARTS ADDITIONAL PHASE I STUDIES WITH ANTI-RSV NANOBODY ALX-0171
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.