AZ’ triple combo COPD inhaler hits PhIII targets

AstraZeneca recently unveiled top-line trial data backing use of an experimental triple combination therapy being developed for use with its Aerosphere technology in patients with chronic obstructive pulmonary disease (COPD).

PT010 - a fixed-dose triple combination therapy of the inhaled corticosteroid (ICS) budesonide, the long-acting muscarinic antagonist (LAMA) glycopyrronium, and the long-acting beta2-agonist (LABA) formoterol fumarate delivered via a pressurised metered-dose inhaler - hit the majority of primary and secondary targets in the Phase III KRONOS trial.

According to AZ, the study showed that PT010 demonstrated a statistically significant improvement versus dual combination therapies in six out of seven lung function primary endpoints based on forced expiratory volume in one second (FEV1) assessments in patients with moderate to very severe chronic forms of the disease.

In total, eight of the nine primary endpoints in the KRONOS trial were met, including two non-inferiority endpoints to qualify PT009, one of the comparators, the drug giant noted, also stressing that there were "no unexpected safety or tolerability signals" thrown up by the trial.

"We are encouraged by the results of the KRONOS trial that has demonstrated PT010’s efficacy in improving lung function and look forward to the ETHOS exacerbation trial results in 2019 that will further characterise the role of this potential treatment for patients with COPD," said AZ’ chief medical officer Dr Sean Bohen.

The KRONOS trial results are to be showcased at a forthcoming medical meeting, while regulatory submissions are expected in Japan and China in the second half of this year followed by potential submissions in the US and Europe in 2019.