Vectura unveiled positive results from two phase 2 studies evaluating the ability of young children and toddlers with asthma to use its nebulized inhaler, suggesting that its VR647 budesonide system could reduce delivery times and lower steroid doses compared to current treatments.
The Chippenham, U.K.-based company also announced its plans to pursue phase 3 studies for the U.S. market. Vectura’s breath-activated delivery system offers real-time, digital feedback, guiding the patient through a specific number of slow, deep breaths and notifying them of successful completion of treatment, while logging adherence data in an app.
One trial showed that children ages 2 to 4 were able to easily use Vectura’s VR647 system equipped with a mouthpiece, diverging from the common belief that young children must use a spacer, facemask or other device when taking an asthma medicine.
The methodology study enrolled 40 children, 1 to 4 years old, to examine their ability to use Vectura’s inhaler to deliver a fixed-dose formulation of the corticosteroid budesonide, as well as the impact of the age of the child on the need for hands-on support from a parent or caregiver.
The study showed 90% of children age 2 and up were able to effectively use the mouthpiece, demonstrating tight control of breathing patterns with no loss of medication, the company said. Vectura is also developing a facemask for children under 2.
“There are very few approved treatment options for children under 5 years of age,” Vectura’s chief medical officer, Gonzalo de Miquel, said in a statement. “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 3 plans with the FDA at the end of the year.”
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The second phase 2 study evaluated VR647’s pharmacokinetics in 17 U.S. children between ages 4 and 8 with symptoms suggestive of asthma. Three different budesonide doses were delivered using Vectura’s inhaler—at 5, 10 and 20 breaths—compared to an approved 1-mg dose of AstraZeneca’s Pulmicort Respules delivered by a conventional jet nebulizer.
According to the company, the VR647 system can achieve the same lung deposition in children with a lower delivered dose without compromising exposure, as well as potentially reduce treatment time by 50% or more. Those results will help define dosing regimens for a planned phase 3 program.