Chippenham, UK-based Vectura says it has now successfully concluded two paediatric studies to support the potential use of asthma drug/device combo VR647.
VR647, which comprises budesonide inhalation suspension together with the firm’s novel proprietary inhalation system, is currently being positioned as an alternative treatment for asthma in children in the US market.
The first study looked at the pharmacokinetics of budesonide delivered using the inhalation system in asthma patients between four and eight years of age.
The second was a methodology study, designed to evaluate the ability of children from one to four years of age to use the VR647 Inhalation System with a mouthpiece.
According to Vectura, the studies suggest that the VR647 Inhalation System may reduce delivery times and potentially reduce steroid dose, versus marketed nebulised treatments in young asthma patients.
“Results from both studies provide high confidence in the programme, supporting the progression of VR647 to a Phase III programme,” the firm noted.
“There are very few approved treatment options for children under 5 years of age. The results of these studies support Vectura’s confidence in our wholly-owned VR647 product as a more convenient treatment option for children,” saidDr Gonzalo de Miquel, Vectura’s executive vice president and chief medical officer.
“This product has the potential to reduce treatment times and the steroid burden for this patient population, without compromising exposure or safety. We look forward to outlining Phase III plans with the FDA at the end of the year.”
Despite generic entry, the firm believes the nebulised budesonide market in the US to offer “a significant market opportunity” with sales of approximately $760 million in 2017, while more than 50 percent of the patient population are eight years old and under.
The studies demonstrate that the VR647 Inhalation System, with the mouthpiece, “can easily be used by young children,” said Dr Leonard Bacharier, Professor of Paediatrics and Medicine at Washington University School of Medicine.
“The real-time feedback and inhalation control with the VR647 Inhalation System is a new way of treating asthmatic children with budesonide, and has the potential to improve compliance and efficacy in a patient population with limited therapy options.”