AstraZeneca has seen another setback in a late-stage trial for chronic obstructive pulmonary disease (COPD) treatments. The latest stumbling block includes a failure for AstraZeneca’s investigational treatment to distinguish itself from a drug already marketed by rival GlaxoSmithKline.
AstraZeneca has seen another setback in a late-stage trial for chronic obstructive pulmonary disease (COPD) treatments. The latest stumbling block includes a failure for AstraZeneca’s investigational treatment to distinguish itself from a drug already marketed by rival GlaxoSmithKline.
Today AstraZeneca said its Phase IIIb drug Bevespi Aerosphere (glycopyrronium/formoterol fumarate) did not do worse than GSK’s Anoro Ellipta, (umeclidinium/vilanterol) on peak forced expiratory volume in one second (FEV1). However, the drug did not do better than the GSK inhaler. Additionally, AstraZeneca said its inhaler displayed non-inferiority on trough FEV1.
Bevespi Aerosphere, a fixed-dose dual bronchodilator combining glycopyrronium, a long-acting muscarinic agonist (LAMA), and formoterol fumarate, a long-acting beta2-agonist (LABA), was approved by the U.S. Food and Drug Administration (FDA) in 2016 for the long-term maintenance treatment of airflow obstruction in COPD. The drug is under review by the European Medicines Agency (EMA). AstraZeneca said it expects a regulatory ruling later this year.
Colin Reisner, head of AstraZeneca’s respiratory development division, noted that the safety and efficacy of Bevespi Aerosphere have already been established in previous trials that involved more than 5,000 patients. Reisner said the performance of Bevespi Aerosphere in the AERISTO trial is inconsistent with previous data the company has collected through other trials.
“A full analysis is underway to understand and characterize these findings and will be presented at a forthcoming medical meeting,” Reisner said in a statement.
This is the second stumble for AstraZeneca’s COPD treatments. In May, the company reported its add-on asthma treatment Fasenra failed to hit endpoints in a Phase III trial of patients with moderate to very severe COPD. Fasenra’s failure to achieve a statistically significant reduction of exacerbations in the TERRANOVA trial came hard on the heels of its failure in the Phase III GALATHEA trial. In that trial, Fasenra also failed to achieve a statistically-significant decrease of exacerbations in COPD patients.
COPD is a progressive disease which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. It affects an estimated 384 million people worldwide and is predicted to be the third-leading cause of death by 2020. About 30 to 40 percent of moderate to severe COPD patients on triple inhaled therapy remain uncontrolled and continue to experience exacerbations.
While the two aforementioned medications hit roadblocks in COPD development, in January AstraZeneca noted its three-in-one inhaler PT010 improved lung function in COPD patients. The trial compared PT010 to Bevespi Aerosphere, Symbicort Turbuhaler and PT009. The company said PT010 outperformed the other drugs, in a statistically significant manner.
AstraZeneca is trying to remain close to GSK in hopes of putting up a medication that can outperform GSK’s Trelegy Ellipta, which was approved for use in the United States 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 Innovia, Inc. If AstraZeneca’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.
A focus on respiratory drugs has been key to AstraZeneca’s strategy, particularly since the $575 million acquisition of Takeda Pharmaceutical’s core respiratory business, including global rights to roflumilast, a treatment for COPD.
