Ablynx begins two additional Phase I studies of ALX-0171 for pediatric development

The Phase I, single-centre study in adults with hyper-responsive airways will determine the probable occurrence of bronchoconstriction after single escalating doses of ALX-0171 in addition to its repeated inhalation.

Including a safety study in adults with hyper-responsive airways and a local and systemic pharmacokinetic (PK) study in healthy volunteers, the studies will determine the appropriate dosing regimen in the subsequent pediatric development of the nanobody.

Ablynx Chairman and CEO Dr Edwin Moses said, "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."

Expected to recruit 24 subjects, the open-label study will also assess the prevention or reversion of bronchoconstriction by administering a standard bronchodilator.

Local and systemic pharmacokinetics of single and repeated daily inhalations of ALX-0171, and the systemic pharmacokinetics of a single intravenous (iv) injection of the nanbody will be evaluated in another Phase I study in healthy male volunteers.

Likely to recruit 41 subjects, the study will observe doses of 0.3 mg/kg (iv) and fixed doses of 200 mg (inhalation).

Results from both the studies are expected during the first half of 2014.