Belgium-based biopharmaceutical company Ablynx has begun two additional phase I studies of anti-respiratory syncytial virus (RSV) trivalent nanobody ALX-0171, to support paediatric development in 2014.
The additional studies include a safety study in adults with hyper-responsive airways and a local and systemic pharmacokinetic study in healthy volunteers. They will determine the appropriate dosing regimen for the paediatric development of the nanobody.
Ablynx chairman and CEO Dr Edwin Moses said that the company’s first inhaled nanobody has the potential to become the top therapeutic to treat RSV in young children, an area with a 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," he said.
The study involves adults with hyper-responsive airways. It will assess the probable occurrence of bronchoconstriction, following single escalating doses of ALX-0171 as well as its repeated inhalation.
It will also assess the prevention or reversion of bronchoconstriction, if indicated, using a standard bronchodilator in 24 subjects.
The phase I study in healthy male volunteers is designed to examine doses of 0.3mg/kg intravenous (IV) injection and fixed doses of 200mg (inhalation) ALX-0171. It will assess the local and systemic pharmacokinetics of single and repeated daily inhalations and the systemic pharmacokinetics of a single IV injection in around 41 subjects.
The company expects results from both of the Phase I studies during the first half of 2014.
Infecting lungs and the respiratory tract, the respiratory virus RSV is the common cause of bronchiolitis and pneumonia in children aged under one.
Image: Transmission electron micrograph of Respiratory Syncytial Virus. Photo: CDC/ Dr. Erskine Palmer.