AstraZeneca's Three-in-One COPD Inhaler Succeeds in Phase III Trial

AstraZeneca has GlaxoSmithKline and its chronic obstructive pulmonary disease (COPD) treatment Trelegy Ellipta squarely in its sights. This morning, AstraZeneca revealed Phase III data that shows its experimental three-in-one inhaler PT010 improved lung function in patients.

AstraZeneca said its Phase III treatment PT010 demonstrated significant improvement in eight out of nine lung function primary endpoints compared with dual combination therapies in patients with moderate-to-very severe COPD. PT1010 delivers a combination dose of budesonide, glycopyrronium and formoterol fumarate to patients. The trial compared PT010 to Bevespi Aerosphere, Symbicort Turbuhaler and PT009. Patients were given two inhalations twice a day of PT010, PT009, Bevespi Aerosphere or Symbicort Turbuhaler. The company said PT010 outperformed the other drugs. Although the company did not provide comparison data it said the Phase III treatment was statistically significant. AstraZeneca said detailed results of the Phase III Kronos trial will be presented at an upcoming medical conference.

There were no unexpected safety concerns detected in the trial, AstraZeneca said.

GSK’s Trelegy Ellipta was approved for use in the United States by the Federal Drug Administration in September 2017. The drug is a once-daily inhalation a combination of an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA), and a long-acting beta2-adrenergic agonist (LABA).  GSK co-developed Trelegy Ellipta with Innoviva Inc.  If AztraZeneca’s drug is approved, some analysts suggested the GSK drug will be preferred due to it being a once-daily dose instead of twice-daily.

Based on the results from the Phase III trial, AstraZeneca said it 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. The company is apparently delaying seeking regulatory approval in the United States until data from another late-stage trial assessing the effect of PT010 on exacerbations from COPD are available.

AstraZeneca Chief Medical Officer Sean Bohen said the company was encouraged the trial results demonstrated the efficacy of PT010. He said the company was looking forward to the ETHOS exacerbation trial results that are expected in 2019. He said those results will "further characterize" the role of PT010 as a treatment for patients with COPD.

COPD is a progressive disease which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness.

A focus on respiratory drugs has been key to AstraZeneca’s strategy, particularly since the $575 million acquisition of Takeda Pharmaceutical Company’s core respiratory business, including global rights to roflumilast, a treatment for chronic obstructive pulmonary disease (COPD). The company is also banking on its new COPD drug, Bevespi Aerosphere, to boost sagging revenue due to stiffer competition from other companies, including GlaxoSmithKline. Last year, AstraZeneca welcomed FDA approval of Fasenra (benralizumab) as an add-on treatment for asthma patients age 12 and older.  In its Phase III trial, benralizumab demonstrated significant reductions in the annual asthma exacerbation rate compared to placebo.

Shares of AstraZeneca are up slightly this morning trading at $36.61 as of 11:06 a.m.