Ablynx (EBR: ABLX) has dosed the first patient in the Japanese Phase II study of ALX-0171, its wholly-owned inhaled Nanobody used to treat respiratory syncytial virus (RSV) infections, the company announced on Friday.
The randomised, double-blind, placebo-controlled, multi-centre Phase II study involves 60 Japanese infants aged 1-24 months that were diagnosed with RSV and hospitalised for a lower respiratory tract infection.
The study will evaluate four different doses, with an independent Data Monitoring Committee conducting a safety review prior to proceeding to each higher dose.
ALX-0171 will be administered via nebulisation once daily for three consecutive days. It will be given in addition to standard-of-care treatment.
Primary objectives of the study include evaluation of the safety, tolerability, and systemic pharmacokinetics (PK) of different doses. Secondary objectives include evaluation of the antiviral effect, clinical activity, immunogenicity, and pharmacodynamics (PD) of different doses of inhaled ALX-0171.
Results from the study are expected to be announced in the second half of 2019.
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