Ablynx, a biopharmaceutical company, recently announced that it is accepting infant- and toddler-aged subjects for a Phase IIa study of ALX-0171, an anti-Respiratory Syncytial Virus (RSV) Nanobody treatment.
The study’s subjects will include RSV-diagnosed toddlers and infants between the ages of 5 months and 24 months.
The goal of the study is to determine the effectiveness of the treatment against RSV infection for neonatal infants. Phase I studies showed that ALX-0171 had positive results with adult RSV subjects
The two-part study will observe five patients given a single, daily dose of ALX-0171 for three consecutive days. The ALX-0171 will be administered through inhalation.
Depending on the initial study results, researchers will then test 30 patients in a double-blind, placebo-controlled portion of the study. The patients will be selected at random for single, daily doses of the placebo or ALX-0171 for three consecutive days.
Researchers will observe subjects in the study in five different European countries. They hope to find locations for additional studies in the Southern Hemisphere.
More than 300,000 children younger than 5 are hospitalized with RSV each year. Anywhere from 70 to 80 percent of children who have the virus are younger than 2 years old.
RSV also causes pulmonary disease in immune-compromised individuals and transplant patients.
There are currently no anti-RSV therapeutic drugs available to the public.