Data from Pharmawand - Curated by EPG Health - Date added 27 November 2018
Vectura Group plc announces that its phase III study of VR 475 in adult and adolescent patients with severe uncontrolled asthma did not meet its primary endpoint. VR 475 is a drug device combination consisting of budesonide delivered by Vectura's proprietary nebuliser inhalation system.
Top-line results indicate a trend in the reduction of the annualised rate of clinically significant exacerbations among patients receiving either VR 475 1mg or VR 475 0.5mg doses twice daily during a 52-week treatment period compared to placebo, but the results did not reach statistical significance. The open label arm with conventional nebuliser also failed to reach statistical significance vs placebo. Available safety data for VR475 are consistent with the known profile of inhaled budesonide.
Based on these results, Vectura has decided to not pursue further the development and partnering of VR 475. The company will complete the full analysis of the primary and secondary data and intends to present the complete study results at an upcoming medical conference and seek to have the data published in a peer-reviewed journal. An initial review of the available secondary endpoints and the safety data show certain endpoints achieving statistically significant and clinically meaningful differences between VR 475 and placebo, and versus conventionally nebulised budesonide. These results reinforce the differential characteristics of our guided inhalation system versus conventional nebulisation, and confidence in the ongoing VR 647 programme and three additional early stage nebulisation programmes, using non- budesonide molecules, announced earlier this year.