Elevation Pharmaceuticals, a San Diego-based company focused on the development of new aerosol therapies, has released positive results from a phase IIb study of EP-101 in patients with chronic obstructive pulmonary disease (COPD), a progressive disease of chronic bronchitis and emphysema.
Patients with moderate to severe COPD treated with EP-101 after seven days had a clinically meaningful and statistically significant improvement in lung function versus placebo. EP-101 is a proprietary inhalation solution formulation of glycopyrrolate, a long-acting muscarinic antagonist (LAMA), delivered by a proprietary investigational eFlow nebulizer device licensed from PARI Pharma GmbH.
"These positive results from our first multi-dose trial of EP-101 are very encouraging and supportive of our mission to significantly improve the standard of care for patients with severe COPD," said Bill Gerhart, president and CEO of Elevation. "Pulmonologists are enthusiastic about the potential availability of a nebulized once-daily LAMA, and patients love the significant improvement in convenience offered by our new handheld delivery device."
The phase IIb study, GOLDEN-1 (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer), was a 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 doses of EP-101 met the primary endpoint of superior efficacy versus placebo as measured by improved lung function—24-hour trough forced expiratory volume in one second (FEV1) (p<0.0005) and FEV1 AUC 0-24 (p<0.0001) on day seven following administration via the eFlow nebulizer.
EP-101 was well-tolerated with a safety and side effect profile comparable to placebo and two active comparators: once daily tiotropium bromide (Spiriva) via Handihaler; and three times daily ipratropium bromide via a conventional jet nebulizer. Patients experienced a robust magnitude and duration of bronchodilation comparable to the active comparators, a rapid onset of action of approximately 5 minutes, and a fast treatment time of less than 3 minutes as delivered via the eFlow nebulizer.
"COPD patients who cannot effectively operate or benefit from a dry powder or metered dose inhaler are prescribed nebulized medicines as a part of their regular maintenance therapy," said Ahmet Tutuncu, CMO at Elevation. "The positive results of this study support continued development of the EP-101/eFlow combination and move us closer to offering a new gold standard in nebulized medicine for COPD patients."
Elevation is preparing to initiate a second phase IIb study in the fourth quarter of 2012 to select the optimal dose of EP-101 for study in the pivotal phase III program.