EP-101, an inhalation solution formulation of glycopyrrolate, a long-acting muscarinic antagonist, delivered by an investigational eFlow nebulizer, demonstrated a statistically significant improvement in lung function compared to placebo in the Phase 2b, randomised, placebo-controlled study.
Elevation Pharmaceuticals senior vice president and chief medical officer Dr. Ahmet Tutuncu said, "The positive outcome of this large Phase 2b study is an important milestone towards our goal of significantly elevating the standard of care for COPD patients who require nebulizer delivery of their medicines."
The 25mcg, 50 mcg, 100 mcg and 200 mcg doses of EP-101 administered as once daily for seven days provided a rapid onset of action, short treatment time and a strong magnitude of bronchodilation compared to placebo.
The bronchodilatory improvements on day seven as assessed by 24-hour forced expiratory volume in one second (FEV1) and the FEV1 AUC (0-12 hours and 12-24 hours) were dose-dependent, statistically significant at all doses compared to placebo, and clinically meaningful at several doses compared to placebo, according to the study data.
EP-101 was well tolerated at all doses, and reported similar adverse event profile compared to placebo and to ipratropium but tended to be higher than treatment with tiotropium.
The company anticipates beginning a second Phase 2b study in the fourth quarter of 2012 to select the dose for Phase 3 studies, scheduled to begin in the second half of 2013.