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AstraZeneca reports positive top-line data from phase III COPD trial

The KRONOS trial showed that Astra’s PT010 inhaler can improve lung function in patients with moderate to severe chronic obstructive pulmonary disease

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Respiratory is a key area of focus for AstraZeneca

AstraZeneca PLC (LON:AZN) has reported positive top-line data from a phase III trial which compared its PT010 therapy for chronic obstructive pulmonary disease (COPD) against existing treatments.

The FTSE 100 drugmaker said its triple combination inhaler “demonstrated a statistically significant improvement” in eight of the nine lung function primary endpoints compared with dual combo therapies.

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COPD is a common condition that mainly affects middle-aged or older adults who smoke and can block airflow to the lungs causing breathing difficulties.

Astra added that no unexpected safety or tolerability signals for PT010 were identified in the trial.

Regulatory submissions in Japan and China are expected in the second half of this year, followed by potential submissions in the US and Europe in 2019.

“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.

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Professor Kalus Rabe, the co-ordinating investigator of the trial, said: “With the KRONOS trial, we are seeing 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.”

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