VIENNA, Sept. 3, 2012 /PRNewswire/ -- Elevation Pharmaceuticals, Inc. today presented positive efficacy and safety results from the GOLDEN-1 study – a Phase 2b study evaluating EP-101 in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) – at the annual meeting of the European Respiratory Society in Vienna, Austria. As previously announced, EP-101 demonstrated a rapid onset, dose-related, statistically significant improvement in lung function compared to placebo. EP-101 is a proprietary inhalation solution formulation of glycopyrrolate, a long-acting muscarinic antagonist (LAMA), delivered by an investigational eFlow® nebulizer (PARI Pharma GmbH).
The GOLDEN-1 study (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer), was a Phase 2b, randomized, placebo-controlled, double-blind, seven-arm, four-period cross-over, incomplete block design, dose-ranging study with seven days of once-daily dosing to assess the pharmacokinetics, safety and efficacy of EP-101 in 140 patients with moderate-to-severe COPD. All four doses (25mcg, 50 mcg, 100 mcg and 200 mcg) of EP-101 administered as once daily for seven days using the investigational eFlow provided a rapid onset of action (five minutes), short treatment time (two minutes), and a robust 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 (p<0.001) at all doses compared to placebo, and clinically meaningful at several doses compared to placebo. In addition, the improvements in lung function with EP-101 doses were comparable to those of once-daily tiotropium dry powder inhaler and three- times daily nebulized ipratropium administered via jet nebulizer.