Vectura successfully concludes two paediatric studies to support the potential use of VR647, its wholly-owned drug/device combination asset for asthma patients.
The first study evaluated the pharmacokinetics of budesonide delivered using Vectura’s VR647 Inhalation System to paediatric asthma patients between four and eight years of age. The second study 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.
The pharmacokinetic and methodology studies suggests that the VR647 Inhalation System may reduce delivery times and potentially reduce steroid dose, versus marketed nebulised treatments in children with asthma. The trials investigated children across different age settings, and results from both studies provide high confidence in the programme, supporting the progression of VR647 to a Phase III programme.
Highlights from the Pharmacokinetic Study included that the VR647 Inhalation System can achieve the same lung deposition in children with a lower delivered dose than the marketed nebuliser delivery system. There is also the potential to reduce budesonide treatment time by 50% or more in children using the VR647 Inhalation System, compared with the marketed product tested.
The highlights of the Methodology study evaluated the impact of the age of the child on their need for hands-on support from a parent or caregiver. the trial demonstrates that children >2 years of age are able to use the mouthpiece of the VR647 Inhalation System. Vectura is also developing a facemask for children under 2 years of age.
Dr. Gonzalo de Miquel, Executive Vice President and Chief Medical Officer, Vectura, commented: “There are very few approved treatment options for children under 5 years of age. This product has the potential to reduce treatment times and the steroid burden for this patient population, without compromising exposure or safety.”
Dr. Leonard Bacharier, Professor of Paediatrics and Medicine at Washington University School of Medicine, commented: “These studies provide very encouraging and positive data, as they demonstrate that the VR647 Inhalation System, with the mouthpiece, can easily be used by young children. The real-time feedback and inhalation control with the 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.”