Vectura starts with testing asthma drug/device combination for children

Vectura Group is moving on with researching and testing its VR647, a drug/device combination to treat asthma in children for the US market.

The Group has received an Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) to begin with the first phase of the clinical trials for the drug/device.

VR647 is Vectura’s nebuliser programme in paediatric asthma which uses Akita Jet smart nebuliser to deliver nebulised budesonide for treating asthma in children aged 8-12. According to Vectura, this product should improve current treatments.

“In June 2015 the FDA agreed with the Group’s plan to rely on the 505(b)(2) pathway for the development programme with the aim of filing a New Drug Application (NDA). This approach requires a small number of clinical studies whose costs are within the Group’s existing guidance for R&D investment. In line with its existing strategy to selectively build a specialist sales capability alongside the Group’s continuing and proven partnering model, VR647 offers a further potentially significant source of recurring revenue,” the company said.

Vectura added that, according to IMS, US sales of nebulised budesonide are approximately $830M per year.

Furthermore, the Group expects the first phase of the pharmacokinetic study in adults to begin in the firts half of 2017 and will inform the doses to be explored in a Phase 2 study in children planned for the second half of 2017.  These studies will be conducted to support initiation of a Phase III study in H2 2018 with the NDA filing anticipated in 2020, the company concluded.