18th Mar 2015 07:15
LONDON (Alliance News) - AstraZeneca PLC Wednesday said it had received positive top-line results from Phase III studies into investigative drug PT003 for the treatment of Chronic Obstructive Pulmonary Disease.
The two 24-week studies looked at whether the treatment improved lung function in patients with the disease. PT003 is a twice-daily fixed-dose combination of glycopyrronium, a long-acting muscarinic antagonist, and formoterol fumarate, a long-acting beta-2 agonist. The treatment is delivered using a pressurised metered dose inhaler developed by Pearl Therapeutics, which was acquired by AstraZeneca in 2013.
AstraZeneca said that in both studies, PT003 demonstrated statistically significant improvements in trough forced expiratory volume in one second FEV1 compared with each drug used on their own and against a placebo. Both the individual drugs also demonstrated statistically significant improvements compared with the placebo.
The most common adverse events across all treatment arms, including placebo, were nasopharyngitis, upper respiratory tract infection, and dyspnea, AstraZeneca said. The incidence of adverse events was generally similar across all treatment groups.
The Phase III programme also included a 28-week extension study, but AstraZeneca is still awaiting the safety information from that.
"These positive top-line results demonstrate the potential of PT003 as a novel treatment for patients suffering with the debilitating and chronic symptoms of COPD. The ability to deliver a unique LAMA/LABA formulation in a single pressurised metered dose device is important for helping some 30% of patients around the world who use an aerosol inhaler," said Briggs Morrison, executive vice president, Global Medicines Development and chief medical officer at AstraZeneca.
AstraZeneca plans to file global regulatory applications for PT003 starting this year.
By Steve McGrath; [email protected]; @stevemcgrath1
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