Elevation Pharmaceuticals has reported positive efficacy and safety results from its Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizser (GOLDEN-1) study of EP-101 in chronic obstructive pulmonary disease (COPD) patients.
The Phase IIb, randomised, placebo-controlled study was designed to assess the pharmacokinetics, safety and efficacy of EP-101 in 140 patients with moderate-to-severe COPD.
According to the study results, EP-101, an inhalation solution formulation of glycopyrrolate, a long-acting muscarinic antagonist (LAMA), delivered by an investigational eFlow nebuliser, demonstrated a rapid onset, dose-related, statistically significant improvement in lung function compared to placebo.
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 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 (p<0.001) 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 a similar adverse event profile compared to placebo and to ipratropium, but tended to be higher than treatment with tiotropium.
The company expects to begin a second Phase IIb study in the fourth quarter of 2012 to select the dose for its Phase III studies, which are scheduled to commence in the second half of 2013.