AstraZeneca has announced top-line results from the Phase 3 KRONOS trial of its PT010 budesonide/glycopyrronium/formoterol fumarate MDI for the treatment of moderate to severe COPD. Compared to Bevespi Aerosphere glycopyrronium/formoterol fumarate, Symbicort Turbuhaler budesonide/formoterol fumarate, and PT009 budesonide/formoterol fumarate, PT010 demonstrated statistically significant improvement in lung function that met 6 out of 7 primary endpoints.
PT010, PT009, and Bevespi Aerosphere (formerly PT003) are based on formulation technology developed by Pearl Therapeutics, which was acquired by AstraZeneca in 2013. Bevespi Aerosphere was approved by the FDA in 2016.
The 24-week KRONOS trial is one of the 4 main Phase 3 trials in the PT010 ATHENA trial program. Together, the ATHENA trials involve 15,500 patients.
AstraZeneca Executive VP, Global Medicines Development, and Chief Medical Officer Sean Bohen commented, “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 characterize the role of this potential treatment for patients with COPD.”
The company said that it plans regulatory submissions in China and Japan in the second half of this year and in the US and Europe in 2019.
Read the AstraZeneca press release.
