LONDON (Alliance News) - Vectura Group PLC said Tuesday it has received approval from the US Food & Drug Administration to conduct a phase I clinical trial for a treatment for paediatric asthma.
FTSE 250-listed Vectura, which develops devices and drugs for inhaled airway disease. said it has received the Investigational New Drug Approval for its VR647 treatment, with a pharmacokinetic study in adults expected in the first half of 2017.
VR647 is a drug and device combination, using the Akita Jet nebuliser to deliver nebulised budesonide, which helps prevent the symptoms of asthma. The treatment is designed for children from 12 months to eight years old and aims for improved delivery of the drug.
The Phase I trial will inform doses to be explored in a Phase II study for children in the second half of 2017. That will be followed by a Phase III study in the second half of 2018 with a New Drug Application filing anticipated in 2020.
"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. 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," said James Ward-Lilley, chief executive officer of Vectura.
By Adam Clark; adamclark@alliancenews.com
Copyright 2017 Alliance News Limited. All Rights Reserved.
