According to Vectura, the FDA has approved the company’s investigational new drug (IND) application for VR647 nebulized budesonide, which the company is developing for the treatment of asthma in children aged 12 months to 8 years.
VR647 is delivered by the Akita Jet smart nebulizer, a technology that Vectura acquired in 2014, when it acquired Activaero.
Vectura plans to initiate a Phase 1 PK study of VR647 in adults by mid-2017 and a Phase 2 study in children in the second half of the year. The company says that it expects to begin a Phase 3 study in the second half of 2018 and to file a 505(b)(2) NDA in 2020.
Vectura CEO James Ward-Lilley commented, “VR647 offers substantial potential harnessing of Vectura’s innovative smart nebulizer technology for superior delivery of an existing drug with a proven track record in an established and significant US market. The FDA’s approval is an important milestone allowing us to commence an accelerated clinical program ahead of potential launch in 2021 as a self-commercialized asset.”
Read the Vectura press release.
