Pearl's PT003 meets COPD endpoint

Pearl Therapeutics Inc. (Redwood City, Calif.) said PT003 met the primary endpoint in a Phase IIb trial to treat chronic obstructive pulmonary disease (COPD). PT003 significantly improved forced expiratory volume in one second (FEV1) area under the curve (AUC) from 0 to 12 hours at day 7 vs. once-daily Spiriva HandiHaler tiotropium bromide, twice-daily Foradil Aerolizer formoterol fumarate, placebo, PT001 and PT005 (p<=0.0002 for all). The double-blind, dose-ranging trial enrolled 118 patients. PT003 is a combination of glycopyrrolate (PT001), a long-acting muscarinic antagonist (LAMA), and formoterol fumarate (PT005), a long-acting beta-2 agonist (LABA), delivered via a single metered-dose hydrofluoroalkane (HFA) inhaler. ...