Elevation Pharmaceuticals, a biopharmaceutical company focused on the development of new aerosol therapies for patients with respiratory diseases, has reported positive results from a phase IIa study of EP-101 in patients with moderate to severe chronic obstructive pulmonary disease (COPD). The results demonstrated a statistically significant and well-tolerated improvement in lung function over the 24-hour time period post dosing for EP-101 versus placebo. EP-101 is a proprietary inhalation solution formulation of glycopyrrolate, a long-acting muscarinic antagonist (LAMA), delivered by an optimized, Investigational eFlowR Nebulizer System (PARI Pharma GmbH).
The randomized, double blind, placebo controlled, cross-over, dose-ranging study evaluated the dose response, efficacy, safety and tolerability of single doses of EP-101 in 42 patients with moderate to severe COPD.
Following a single administration of one of several doses or placebo, all doses achieved a rapid onset of action (five minutes), short treatment time (two minutes), and a robust magnitude of bronchodilation compared to placebo. The bronchodilatory improvements as assessed by forced expiratory volume in one second (FEV1), a standard measure of lung function, 24 hours after dosing was dose-dependent, statistically significant at all doses compared to placebo, and clinically meaningful at several doses compared to placebo. Favorable efficacy trends were also seen in a number of other endpoints including sustained improvements in FEV1 over the entire 24-hour period, demonstrating the potential for once-daily dosing. Throughout the study period, EP-101 was well tolerated at all doses with a comparable safety profile to placebo.
EP-101 can be the first LAMA approved for a nebulizer, and it is being developed in combination with an investigational eFlow device - a portable nebulizer providing short treatment times - significantly improving the standard of care for the large underserved subpopulation of COPD patients not adequately treated by conventional inhalers or nebulizers.