AstraZeneca reports positive trial data for new combination COPD therapy

AstraZeneca has announced the findings of a clinical trial that demonstrates the effectiveness of a new treatment for chronic obstructive pulmonary disease (COPD).

Topline results from the phase III KRONOS trial showed the PT010 combination of budesonide, glycopyrronium and formoterol fumarate demonstrated a statistically significant improvement compared with dual combination therapies among patients with moderate to very severe COPD.

PT010 met six out of seven primary lung function endpoints, with eight of the nine primary endpoints in the KRONOS trial met in total, including two non-inferiority endpoints to qualify PT009, one of the comparators.

The KRONOS results will be presented in full at a forthcoming medical meeting, with AstraZeneca now expecting to file regulatory submissions for this new therapy in Japan and China in the second half of 2018, followed by potential filings in the US and Europe in 2019.

Dr Sean Bohen, executive vice-president for global medicines development and chief medical officer at AstraZeneca, said: "We are encouraged by the results of the KRONOS trial, which has demonstrated PT010's efficacy in improving lung function, and look forward to the ETHOS exacerbation trial results in 2019."

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