AstraZeneca has announced that data from two Phase 3 studies of its PT003 glycopyrronium/formoterol MDI for the treatment of COPD showed statistically significant improvements in lung function for patients using PT003 compared to each of its components and to placebo. In 2013, Pearl Therapeutics announced the initiation of the Phase 3 program less than a month before Pearl was acquired by AstraZeneca.
Data from the 24-week PINNACLE 1 and PINNACLE 2 studies also showed statistically significant improvements in trough FEV1 for both components of PT003 — PT001 (glycopyrronium) and PT005 (formoterol fumarate) — versus placebo. No significant difference in adverse effects was apparent across all of the treatment groups, including placebo.
AstraZeneca Executive VP, Global Medicines Development and Chief Medical Officer Briggs Morrison commented, “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.”
The company said that it intends to file regulatory applications for PT003 starting this year.
Read the AstraZeneca press release.
