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AstraZeneca to press on with triple-dose COPD drug after Kronos success
AstraZeneca found a statistically significant improvement in eight out of nine lung functions for patients tested with its 'PT010' triple-combination drug delivered with a inhaler in late-stage clinical trials.
Buoyed by these 'Kronos' trials on patients with moderate to very severe chronic obstructive pulmonary disease (COPD), the FTSE 100 drugmaker now plans to apply for regulatory permission in Japan and China in the second half of this year, followed by potential submissions in the US and Europe in 2019.
Inhaled doses twice a day of PT010, which is a combination of budesonide, glycopyrronium and formoterol fumarate, were given to COPD sufferers via a pressurised metered-dose inhaler in a 24-week, chronic-dosing, multi-centre trial to assess the efficacy and safety of the treatment. No unexpected safety or tolerability signals were observed.
"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 chief medical officer Sean Bohen.
Klaus Rabe, professor of pulmonary medicine at the University of Kiel and co-ordinator of the trial, added that the trial was demonstrating the potential of PT010 as a triple combination therapy for COPD.
"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 trial compared PT010 to Astra's own Bevespi Aerosphere combination of glycopyrronium and formoterol fumarate; as well as its Symbicort Turbuhaler, a mix of budesonide and formoterol fumarate, and Pearl Therapeutics' PT009, which is a combination of budesonide and formoterol fumarate using Aerosphere delivery technology. Patients were given two inhalations twice a day of PT010, PT009, Bevespi Aerosphere or Symbicort Turbuhaler.