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news.AstraZeneca has reported positive top-line results from the Phase III PINNACLE program of PT003, a twice-daily fixed-dose combination of glycopyrronium and formoterol fumarate, to improve lung function in patients with chronic obstructive pulmonary disease (COPD).
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The Phase III program included two pivotal 24-week trials PINNACLE 1 and PINNACLE 2, which evaluated the potential of this fixed-dose combination.
Glycopyrronium is a long-acting muscarinic antagonist (LAMA), while formoterol fumarate is a long-acting beta-2 agonist (LABA).
PT003 is claimed to be the first LAMA/LABA combination to be delivered in a pressurised metered dose inhaler (pMDI) using Pearl Therapeutics’ porous particle co-suspension technology.
AstraZeneca Global Medicines Development executive vice-president and chief medical officer Dr Briggs Morrison said: "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.
"Today’s results are also encouraging for the development of our investigative triple-drug combination of LAMA/LABA and inhaled corticosteroids."
In 2013, AstraZeneca acquired Pearl Therapeutics, a developer of dual and triple combination products to treat widely prevalent respiratory diseases, including COPD.
The development program also included evaluation of the individual components of PT003, glycopyrronium pMDI (PT001) and formoterol fumarate (PT005) pMDI.
The company said that the completion of PINNACLE trials marks the first Phase III outcomes from a series of pipeline candidates being developed by AstraZeneca using Pearl’s new technology.
Primary objective in both the trials was to evaluate benefits on lung function as measured by trough forced expiratory volume in one second (FEV1).
PT003 showed statistically significant improvements in trough FEV1 versus PT001, PT005 and placebo, while both PT001 and PT005 also showed statistically significant improvements in trough FEV1 compared to placebo.
The company intends to submit global regulatory applications for PT003 starting in 2015.
The PT003 Phase III program, which includes PINNACLE 1, PINNACLE 2, and an extension study, PINNACLE 3, enrolled more than 3,700 patients with COPD at over 275 study sites.
Image: AstraZeneca’s PT003 Phase III PINNACLE program included two 24-week trials PINNACLE 1 and PINNACLE 2, and extension study PINNACLE 3. Photo: courtesy of Baitong333/ FreeDigitalPhotos.net.