Drug trials using Vectura's Fox nebuliser make progress

A respiratory treatment being developed using Vectura's Fox nebuliser technology device has passed safety and efficacy trials and looks likely to be moved into a Phase II efficacy study in infants.

Drug developer Ablynx has published positive results from first-in-infant Phase I/IIa study of its inhaled ALX-0171 nanobody to treat 53 infants who had been hospitalised by a respiratory syncytial virus (RSV) infection.

The trial hit its target of demonstrating favourable safety and tolerability profile when administered daily by inhalation in the target infant population using the FTSE 250 company's Fox nebuliser, with no serious adverse events reported due to the treatment.

A hand-held battery-powered inhalation system, the Fox device delivers nebulised liquid drugs using a vibrating mesh technology that is proprietary to Vectura and which times the flow of an aerosolised drug immediately after the patient has inhaled.

RSV is a very common virus that leads to cold-like symptoms in adults and older healthy children but can be more serious in infants, especially those in certain high-risk groups.

Ablynx also said its nanobody was detected in the serum of RSV subjects after treatment, indicating it had been absorbed in the lungs, while anti-drug antibodies had no effect on the passage of the drug through the body and no adverse events were seen.

Treatment with the inhaled drug was found to have an immediate impact on viral replication and also reduced viral load, as compared to placebo.

Analysis of a composite of clinical efficacy endpoints led to an encouraging initial indication of a therapeutic effect for infants treated with ALX-0171.

Vectura chief executive James Ward-Lilley said the results and the additional marked antiviral effect in RSV-infected infants was a positive step that "Ablynx believes support advancement into a Phase II efficacy study in infants".

He added: "This progress is a further example of how Vectura continues to a partner of choice for the application of novel formulation and device technologies in the development of medicines."

Shares in Vectura, which hit an all-time high of 188.5p in January, were up 0.7% to 173.2p by mid afternoon on Tuesday.