AstraZeneca on Friday announced that a study has shown PT010 demonstrated a 'statistically significant' improvement in patients with 'moderate to very severe' chronic obstructive pulmonary disease.
AstraZeneca said top-line results from the Phase III KRONOS trial that showed PT010 using Aerosphere Delivery Technology, demonstrated a statistically significant improvement in eight out of nine lung function primary endpoints based on forced expiratory volume in one second or FEV1 assessments in patients with moderate to very severe chronic obstructive pulmonary disease or COPD.
KRONOS is a randomised, double-blind, parallel-group, 24-week, chronic-dosing, multi-centre trial to assess the efficacy and safety of PT010. The trial compared PT010 to Bevespi Aerosphere. PT010 is being developed using AstraZeneca's Aerosphere Delivery Technology.
Dr. Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, said: '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."
Klaus Rabe, Professor of Pulmonary Medicine at the University of Kiel, Director of the Department of Pneumology at Clinic Grosshansdorf, Germany, and National Co-ordinating Investigator of the KRONOS trial, said: 'I expect the triple class of medicines to play an increasingly important role in addressing the needs of the many COPD patients who are currently undertreated or are receiving triple combination therapy as separate medicines in multiple devices.'
The KRONOS trial results will be presented at a forthcoming medical meeting. AstraZeneca anticipates making regulatory submissions in Japan and China in the second half of 2018, followed by potential submissions in the US and Europe in 2019.