Ablynx has completed target enrolment of a phase I/IIa safety study of its anti-RSV nanobody, ALX-0171 for the treatment of respiratory syncytial virus (RSV) infection in infants
ALX-0171 is a wholly-owned nanobody drug candidate, administered through inhalation, for the treatment RSV infection in infants.
Edwin Moses, chief executive officer of Ablynx, said: "Ablynx is pioneering the development of a potentially first-in-class treatment for RSV infection, an area of major unmet need, especially in infants. “
The study is on track to publish results in the first half of 2016 according to Anlynx.
The Company also announced that following a positive recommendation from an independent Data Monitoring Committee (DMC) based on data available for the first 15 infants from the placebo-controlled part of this Phase I/IIa safety study, the age requirement for infants in the trial has been reduced from 3 months to 1 month.
The Phase I/IIa study will now continue with an expansion cohort enrolling younger infants aged 1-5 months during the remaining RSV season in Northern Europe.
This will enable the collection of additional data on ALX-0171 in a younger patient population.
Moses said: “We are utilising a key characteristic of our Nanobodies to deliver them via nebulisation directly to the site of infection, a capability which may be beneficial in other pulmonary diseases.
“ALX-0171 is one of our wholly-owned, proprietary programmes in clinical development and we believe that completing target enrolment of this first-in-infant study is a major accomplishment for our Company.
“We are looking forward to releasing top line results from this safety study in the first half of 2016 with further data from the expansion cohort anticipated in the second half of 2016.
“In parallel, we will continue with the preparations to initiate the next clinical study in infants, which is expected to start recruiting by the end of 2016."