AstraZeneca PLC Two-in-One Lung Drug Succeeds in Phase III Trial
March 18, 2015
By Alex Keown, BioSpace.com Breaking News Staff
CAMBRIDGE, England – The positive results of AstraZeneca PLC ’s Phase III clinical trial for PT003, a drug to improve lung function in people with Chronic Obstructive Pulmonary Disease (COPD), will have patients breathing a bit easier and will help boost the company’s respiratory pipeline.
The drug, PT003, is AstraZeneca’s combination of glycopyrronium, a long-acting muscarinic antagonist (LAMA) and formoterol fumarate, a long-acting beta-2 agonist (LABA). The drug is the first LAMA/LABA combination to be delivered in a pressurized metered dose inhaler using the porous particle co-suspension technology developed by Pearl Therapeutics, which was acquired by AstraZeneca in 2013. The metered dose inhaler may make it easier for some patients to inhale. Each dose should be effective for about 12 hours. The Phase III double-blind trial included more than 3,700 patients with COPD at over 275 study sites. During the year-long trial some patients were provided with a placebo, while others were administered PT003 twice per day.
This will be the first AstraZeneca respiratory pipeline candidate to use the Pearl technology.
AstraZeneca plans to file global regulatory applications for PT003 later this year.
“The ability to deliver a unique LAMA/LABA formulation in a single pressurized metered dose device is important for helping some 30 percent of patients around the world who use an aerosol inhaler,” Briggs Morrison, AstraZeneca’s chief medical officer said in a press release.
AstraZeneca has a long history in the manufacture of respiratory medications. The company is the maker of Symbicort and Pulmicort, two medicines used to treat asthma and COPD. Last month AstraZeneca reported Symbicort earned $978 million and Pulmicort earned $269 million during the third quarter. Additionally AstraZeneca manufactures COPD drugs, Eklira Genuair, Tudorza Pressair and Duaklir Genuair.
COPD is a progressive disease which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. Emphysema and chronic bronchitis are the two most common conditions that make up COPD. It affects an estimated 300 million people worldwide and is predicted to be the third leading cause of death by 2020. Doctors treat COPD with a variety of medications including inhaled steroids, bronchodilators, oral steroids, antibiotics, theophyline, combination inhalers and more.
The Phase III trial showed the most common negative reactions were nasopharyngitis, upper respiratory tract infection, and dyspnea. The incidence of adverse events was generally similar across all treatment groups.
Last month AstraZeneca boosted its respiratory portfolio through an $800 million deal with Actavis plc . Under terms of the deal, AstraZeneca will acquire the U.S. and Canadian rights to Tudorza Pressair and Daliresp, both used to treat COPD. Combined annual sales of those products in the United States were about $230 million in 2014.
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