OREANDA-NEWS. Vectura Group plc (LSE: VEC; "Vectura" or "the Company"), is delighted with the information released by Ablynx confirming that it has completed target enrolment of the first-in-infant Phase I/IIa safety study with its wholly-owned anti-RSV Nanobody, ALX-0171, and is on track to publish top line results in the first half of 2016.

Ablynx has 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. Results from this extension will be available in the second half of 2016.

ALX-0171 is a Nanobody drug candidate, administered through inhalation, for the treatment of respiratory syncytial virus (RSV) infection in infants. VR465 is being developed by our partner Ablynx and utilises Vectura's smart nebuliser technology device, the FOX®, to deliver the Nanobody to patients. The FOX® device used in this programme has been adapted for use with neonates and infants.

The FOX® device is a hand-held, self-contained, battery powered inhalation system that delivers nebulised liquid drugs with high performance using a vibrating mesh technology.  The mesh-based aerosolisation engine is proprietary to Vectura.  As with all of Vectura's smart nebuliser delivery systems, the FOX® provides targeted inhalation therapy for applications where precise and targeted delivery to the lungs is needed.  To achieve this, the device creates a liquid aerosol and co-ordinates delivery after the patient has inhaled using the FAVORITE (Flow And Volume Regulated Inhalation TEchnology) principle for precise delivery to the lungs. The FOX® inhalation system also makes use of a flow sensing/controlling value system, is rechargeable and can be Bluetooth®-enabled. FOX® is CE marked and 510(k) approved and in April 2014, gained a Red Dot Award for product design.

James Ward-Lilley CEO, commented:

"This development is a very positive step and we look forward to the release of the top line results from this safety study in the first half of 2016. This announcement demonstrates a validation of the technology from the acquisition of Activaero and is underpinned by the excellent relationship, combining the device capabilities of Vectura and the powerful Nanobody technology and development expertise of our partner. Vectura continues to be viewed as a partner of choice in the application of novel formulation and device technologies in the development of new medicines by companies seeking to address the unmet medical needs of patients with airway diseases."