AstraZeneca chief medical officer Dr Sean Bohen. Credit: © AstraZeneca.

AstraZeneca has reported top-line results from the Phase III KRONOS clinical trial of PT010 in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).

Results indicated statistically significant improvement in six out of seven lung function primary endpoints when compared to dual combination therapies.

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PT010 is a fixed-dose triple combination therapy of 320µg of an inhaled corticosteroid (ICS) called budesonide with 14.4µg glycopyrronium (LAMA) and 9.6µg formoterol fumarate, a LABA.

Developed using the firm’s Aerosphere Delivery Technology, PT010 is delivered through a pressurised metered-dose inhaler (pMDI).

The randomised, double-blind, parallel-group, chronic-dosing, multi-centre KRONOS trial evaluated the efficacy and safety of PT010 over a period of 24 weeks.

“We are encouraged by the results of the KRONOS trial that has demonstrated PT010’s efficacy in improving lung function.”

The trial included Bevespi Aerosphere (glycopyrronium/formoterol fumarate 14.4/9.6µg pMDI), Symbicort Turbuhaler (budesonide/formoterol fumarate 400/12µg) and PT009 (budesonide/formoterol fumarate 320/9.6µg) as comparators.

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Trial subjects were administered with two inhalations of PT010, PT009, Bevespi Aerosphere or Symbicort Turbuhaler two times a day.

In total, the Phase III trial is reported to have met eight of nine primary endpoints, including two non-inferiority endpoints to qualify PT009. Results did not show any unexpected safety or tolerability signals for PT010.

AstraZeneca global medicines development executive vice-president and chief medical officer Dr Sean Bohen 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.”

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