Elevation Pharmaceuticals has announced positive results from a Phase 2b study of EP-101 in patients with chronic obstructive pulmonary disease (COPD), a progressive disease comprising chronic bronchitis and emphysema.
The Phase 2b randomised, placebo-controlled, double-blind, four-period cross-over, incomplete block design, dose-ranging, Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer (GOLDEN-1) study evaluated the pharmacokinetics, safety and efficacy of EP-101 in 140 patients with moderate to severe COPD.
EP-101 is a proprietary inhalation solution formulation of glycopyrrolate, a long-acting muscarinic antagonist (LAMA), delivered by PARI Pharma's investigational eFlow nebuliser device, which employs eFlow technology to enable efficient aerosolisation of medications through a vibrating and perforated membrane.
Following seven days of treatment with EP-101, COPD patients had a clinically meaningful and considerable improvement in lung function when compared to placebo treatment.
Bill Gerhart, Elevation Pharmaceuticals president and CEO, said the positive results from the first multi-dose trial of EP-101 are encouraging and support the company's mission to improve the standard of care for patients with severe COPD.
"Pulmonologists are enthusiastic about the potential availability of a nebulised, once-daily LAMA and patients love the significant improvement in convenience offered by our new handheld delivery device," Gerhart added.
In the study, all doses of EP-101 met the primary endpoint of superior efficacy versus placebo, as measured by improved lung function, a 24-hour trough forced expiratory volume in one second (FEV1).
Elevation Pharmaceuticals chief medical officer Ahmet Tutuncu said the positive data from the Phase 2b study support continued development of the EP-101/eFlow combination for COPD patients.
The company is planning to begin a second Phase 2b study in the fourth quarter of 2012, to select the optimal dose of EP-101 for study in the pivotal Phase 3 programme.