Ablynx Reports Positive Top Line Results For Its Anti-RSV Nanobody (ALX-0171) Inhaled Using Vectura’s FOX Device In A Phase I/IIa Study In Infants Hospitalized With RSV Infection

• Primary endpoint of safety and tolerability met

• Anti-viral effect demonstrated and encouraging initial indication of therapeutic effect

• Results support advancing the programme into a Phase II efficacy study in infants

• Potential general proof-of-principle for the administration of Nanobodies® by inhalation

Chippenham, UK – 3 May 2016: Vectura Group plc (LSE: VEC; “Vectura” or “the Company”), announce the results of their partner, Ablynx, positive top line results from the first-in-infant Phase I/IIa study of its wholly-owned, inhaled, anti-RSV Nanobody, ALX-0171, in 53 infants, aged 1-24 months, hospitalised as a result of a respiratory syncytial virus (RSV) infection. The study met its primary endpoint, demonstrating the favourable safety and tolerability profile of ALX-0171 when administered daily by inhalation in the target infant population, with no treatment-related serious adverse events reported.ALX-0171 was detected in the serum of subjects after treatment, consistent with lung exposure. Anti-drug antibodies had no effect on the pharmacokinetics and no relation with adverse events was seen. Treatment with inhaled ALX-0171 had an immediate impact on viral replication and also reduced viral load, as compared to placebo. Analysis of a composite of clinical efficacy endpoints, the Global Severity Score1, led to an encouraging initial indication of a therapeutic effect for infants treated with ALX-0171.

VR465 – Global

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.

FOX®

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:

“These results and the additional marked antiviral effect in RSV-infected infants is a positive step which Ablynx believes support advancement into a Phase II efficacy study in infants. This announcement continues to demonstrate a validation of the Vectura smart nebuliser technology underpinned by a strong partnering relationship, combining the device capabilities of Vectura and the powerful Nanobody technology and development expertise of Ablynx. This progress is a further example of how Vectura continues to be a partner of choice for the application of novel formulation and device technologies in the development of medicines.”

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