Vectura concludes two paediatric studies into VR647

The London-listed company said the first study evaluated the pharmacokinetics of budesonide delivered using its VR647 inhalation system to paediatric asthma patients between four and eight years of age.

It said 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 could reduce delivery times and potentially reduce steroid dose, versus marketed nebulised treatments in children with asthma.

Vectura said the trials investigated children across different age settings, and results from both studies provided “high confidence” in the programme, supporting the progression of VR647 to a Phase III programme.

This US study investigated 17 paediatric patients from four to eight years of age with symptoms suggestive of asthma.

Pharmacokinetics were obtained for three different budesonide doses delivered with the VR647 inhalation system and an approved 1mg budesonide dose delivered using a marketed nebuliser.

“There are very few approved treatment options for children under 5 years of age,” said Vectura’s executive vice-president and chief medical officer Dr Gonzalo de Miquel.

“The results of these studies support Vectura's confidence in our wholly-owned VR647 product as a more convenient treatment option for children.

“This product has the potential to reduce treatment times and the steroid burden for this patient population, without compromising exposure or safety.”