AstraZeneca Plans to Seek Regulatory Approval for COPD Drug PT010 Following Phase III Trial

Inhaler COPD

Following a setback in a chronic obstructive pulmonary disease (COPD) clinical trial in August, AstraZeneca unveiled data from a separate trial on Sunday that showed its triple combination therapy PT010 outperformed its dual-therapy rivals eight of nine times.

PT010 is a combination of budesonide, glycopyrronium and formoterol fumarate. In the Phase III KRONOS trial, AstraZeneca pitted PT010 against Bevespi Aerosphere (glycopyrronium/formoterol fumarate), Symbicort Turbuhaler (budesonide/formoterol fumarate) and its investigational PT009 (budesonide/formoterol fumarate) in patients with moderate to very severe COPD regardless of whether or not they had an exacerbation in the prior year.

Data from the trial was presented at the European Respiratory Society (ERS) International Congress 2018 and also published in The Lancet Respiratory Medicine. AstraZeneca said the KRONOS trial met eight of nine primary lung function endpoints. Additionally, in key secondary endpoint, PT010 showed a statistically significant 52 percent reduction in the rate of moderate or severe COPD exacerbations compared with Bevespi Aerosphere in the trial patient population. PT010 also demonstrated 18 percent and 17 percent reductions in the rate of moderate or severe COPD exacerbations versus PT009 and Symbicort, respectively, AstraZeneca said. The company noted that these are “numerically but not statistically significant improvements.”

AstraZeneca said it intends to begin making regulatory submissions for PT010 by the end of this year.

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.

Colin Reisner, head of respiratory, global medicines at AstraZeneca, said the company is encouraged by the KRONOS data. Reisner said the data demonstrated PT010’s efficacy in improving lung function, as well as its “potential value as a triple combination therapy for patients with COPD.” Specifically, Reisner pointed to the trial data that showed the treatment’s benefits in COPD compared to Bevespi Aerosphere. Reisner further added that the company is looking forward to seeing how PT010 fared in the ETHOS exacerbation trial. Data from that trial is expected in 2019 and he said it will “further characterize PT010.”

The lead trial investigator, Gary Ferguson, said a priority for managing COPD patients is preventing exacerbations. It’s important because those exacerbations have an impact on lung function and mortality.

AstraZeneca said there were no new or unexpected safety or tolerability signals for PT010 in the KRONOS trial. The adverse events profile was consistent with that observed in previous trials, the company added.

“Patients are at risk even if they haven’t had an exacerbation in the previous 12 months. The KRONOS trial demonstrated that PT010 reduces the risk of an exacerbation versus LAMA/LABA combination therapy in symptomatic COPD patients regardless of whether or not they’ve had an exacerbation in the previous year,” Ferguson said in a statement.

In August, AstraZeneca reported Bevespi Aerosphere failed to distinguish itself against GlaxoSmithKline's Anoro Ellipta in treating COPD patients. The company noted that Bevespi Aerosphere did no better and no worse than the rival product. That was the second stumble for AstraZeneca’s COPD treatments this year. 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 chronic obstructive pulmonary disease.

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