PT 003 (Pearl Therapeutics) success in Phase IIB study for COPD - 26-Oct-2012

Pearl Therapeutics Inc. has announced the completion of a randomized, double-blind, dose-ranging Phase IIb trial of PT003, Pearl's lead investigational inhaled combination bronchodilator product for the treatment of patients with moderate-to-severe COPD. This study assessed five BID doses of PT003, in which formoterol fumarate (FF) was co-formulated with five descending doses of glycopyrrolate (GP) and administered via metered-dose inhaler (MDI). Multiple doses of PT003 were shown to provide superior bronchodilation compared to open-label tiotropium and monotherapy components, GP MDI (PT001) and FF MDI (PT005). Based on these dose-ranging results and the previously identified minimally effective doses of GP MDI and FF MDI, Pearl has selected an optimal dose of PT003 for testing in Phase III. Importantly, this study also demonstrated the benefit of combining GP and FF in the fixed-dose combination, PT003, providing supportive evidence for the U.S. regulatory requirement known as the "combination rule.