AstraZeneca announces results from their Phase III KRONOS trial showing PT010 demonstrated a statistically significant improvement in eight out of nine lung function primary endpoints based on forced expiratory volume in one second (FEV1) assessments in patients with moderate to very severe chronic obstructive pulmonary disease (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 (glycopyrronium/formoterol fumarate 14.4/9.6µg pMDI), Symbicort Turbuhaler (budesonide/formoterol fumarate 400/12µg) andPT009 (budesonide/formoterol fumarate 320/9.6µg using Aerosphere Delivery Technology in a pMDI, being characterised to qualify as a relevant comparator in clinical trials for PT010).1 Patients were given two inhalations twice a day of PT010, PT009, Bevespi Aerosphere or Symbicort Turbuhaler. There were no unexpected safety or tolerability signals for PT010 identified in 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 Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer.
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.