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Results of a Phase 3 clinical trial, KRONOS, evaluating AstraZeneca (NYSE: AZN) triplet treatment with PT010 (budesonide / glycopyrronium / formoterol fumarate) compared to dual therapies Aerosphere Bevespi (glycopyrronium fumarate / formoterol), Symbicort Turbuhaler (budesonide / formoterol fumarate) and PT009 (budesonide / formoterol fumarate) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) have shown significant therapeutic benefit. The data was presented at the ERS International Congress in Paris and published in The Lancet Respiratory Medicine.
KRONOS met eight of the nine key evaluation criteria for effectiveness. It also met a key secondary endpoint showing that treatment with PT010 reduced the rate of moderate / severe COPD exacerbations by 52% compared with Aerosphere Bevespi in a patient population that had not needed exacerbation in the past 12 months. PT010 reduced the rate of these exacerbations by 18% and 17%, respectively, compared with PT009 and Symbicort, but the separations were not statistically significant.
No new safety signal has been observed.
Regulatory submissions must be filed in the fourth quarter.
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