Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Sosei and Vectura Group's novel chronic obstructive pulmonary disease treatment candidate NVA237 has successfully completed a phase IIb multiple dose-ranging clinical trial.
Subscribe to our email newsletter
NVA237 is a collaborative product of Sosei and Vectura that is being developed and commercialized by Novartis, both as a monotherapy and in combination with its once-daily bronchodilator indacaterol, under a global license agreement.
The trial randomized 335 subjects in 35 European sites into a multi-centre double-blind, parallel group, placebo controlled study, including an additional open label tiotropium group, to assess the efficacy, safety and tolerability of four doses of NVA237 inhaled once daily for 28 days in subjects with chronic obstructive pulmonary disease (COPD).
In the trial, NVA237 demonstrated bronchodilatory efficacy, as determined by a range of pulmonary function measures. NVA237 achieved statistical significance over placebo in terms of the primary efficacy variable, trough FEV1 and was comparable to tiotropium. These data support the use of NVA237 as a once daily bronchodilator.
Preliminary data indicate that the majority of adverse events were mild and there were no marked differences in incidence or severity compared to placebo or tiotropium.
The outcome of the study supports the progression of NVA237 and Novartis is proceeding as planned with the development program.