US regulators have given UK-based Vectura a green light to carry out a Phase I clinical trial of VR647, a drug/device combination being developed for paediatric asthma.
VR647 uses the AKITA JET smart nebuliser to deliver nebulised budesonide for maintenance treatment and prophylactic therapy of asthma in children (12 months to 8 years).
The company is hoping that the device will significantly improve on currently available nebulised delivery of budesonide, with a faster delivery time and better lung deposition where there is potential for reducing the dosage whilst maintaining similar efficacy, thereby reducing the risk of local and systemic side effects.
The Phase I pharmacokinetic study in adults is expected to be start in the first half of 2017, to determine which doses will then be tested in a Phase II study in children, planned for the second half of the year.
These studies will support initiation of a Phase III study in the second half of 2018, with a New Drug Application filing expected in 2020, the firm noted.
"VR647 offers substantial potential harnessing of Vectura's innovative smart nebuliser technology for superior delivery of an existing drug with a proven track record in an established and significant US market," noted James Ward-Lilley, Vectura's chief executive.
"The FDA's approval is an important milestone allowing us to commence an accelerated clinical programme ahead of potential launch in 2021 as a self-commercialised asset."