Vectura has announced that a Phase 3 study of VR475 budesonide inhalation suspension for the treatment of severe uncontrolled asthma in adult and adolescent patients failed to meet its primary endpoint. As a result, the company said that it would discontinue development of VR475 (formerly known as Favolir), which it acquired when it acquired Activaero in 2014.
According to the company, patients receiving VR475 via the Akita Jet nebulizer system experienced a reduction in significant exacerbations; however, the reduction was not statistically significant. The 52-week study enrolled 713 patients and compared VR475 0.5mg, VR475 1mg, and budesonide delivered by conventional nebulizer. None of the arms, including the conventional nebulization arm, reached statistical significance.
The achievement of some secondary endpoints in the VR475 study, the company said, “reinforce the differential characteristics of our guided inhalation system versus conventional nebulization, and confidence in the ongoing VR647 program and three additional early stage nebulization programs, using non- budesonide molecules.”
Vectura Chief Medical Officer and Executive VP, Development, Gonzalo de Miquel commented, “Although we are disappointed that these results missed statistical significance, I remain confident in our proprietary technology and development capabilities. Vectura remains fully committed to enhancing respiratory medications by developing better formulations and superior inhalation systems for patients. I would like to thank patients, caregivers, investigators and our staff for their participation in what has been a well conducted and executed study.”
Read the Vectura press release.
