Vectura says it no longer plans to develop and partner experimental asthma therapy VR475, after it failed to hit Phase III targets.
VR475 is a drug device combination consisting of budesonide delivered by Vectura's proprietary nebuliser inhalation system, which the firm was developing to treat adult and adolescent patients with severe uncontrolled asthma.
However, while top-line results indicate a trend for reducing the annualised rate of clinically significant exacerbations compared to placebo, the results did not reach statistical significance.
The open label arm using a conventional nebuliser also failed to reach statistical significance versus placebo, the firm noted.
Vectura said it would complete a full analysis of the primary and secondary data and present results at an upcoming medical conference, but confirmed it would no longer be developing the drug in this setting.
“The study outcome is disappointing, however the primary endpoint in this difficult-to-treat patient population presented a high hurdle from the outset,” said principal investigator Professor Tim Harrison, of the Faculty of Medicine and Health Sciences at the University of Nottingham.
“The results suggest that in these study patients with severe asthma, nebulised budesonide is not an appropriate treatment alternative to biologic therapy. Whether there is a specific severe asthma phenotype who could gain greater benefit remains a distinct possibility.”
“Although we are disappointed that these results missed statistical significance, I remain confident in our proprietary technology and development capabilities,” added Gonzalo de Miquel, Vectura’s chief medical officer and executive vice president Development.