Authored by Karl Simpson
The Belgian biotech company, Ablynx, which develops Nanobodies® for a range of disease indications, this week announced it intends to begin additional Phase I studies with the company’s anti-RSV Nanobody® ALX-0171. The two additional studies are being conducted to determine appropriate dosing regimen for subsequent paediatric development of the Nanobody, slated to begin during the second half of next year (2014) once these Phase I studies have been concluded.
Respiratory Syncytial Virus (RSV), the disease indication, is a respiratory virus which infects the lungs and the respiratory tract and commonly causes bronchiolitis and pneumonia in children less than 12 months old. It is estimated that is causes over 300,000 child hospitalisations per year in seven major pharma markets.
The studies will include a safety study in adults with hyper-responsive airways and a local and systemic pharmacokinetics study in healthy volunteers. Also, 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.
Ablynx currently has around 25 clinical programmes running and 6 of its Nanobodies® at clinical development stage.
