Elevation Pharmaceuticals Inc., a pharmaceutical company focused on the development of new aerosol therapies for patients with respiratory diseases, has reported positive results from a phase II b study of EP-101 in patients with chronic obstructive pulmonary disease (COPD), a progressive disease comprising chronic bronchitis and emphysema caused largely by smoking.
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 II b 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].
“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,” states Dr Ahmet Tutuncu, chief medical officer 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 II b study in the fourth quarter of 2012 to select the optimal dose of EP-101 for study in the pivotal phase III programme. The complete results of the GOLDEN-1 trial will be presented at a future medical conference.
COPD is a progressive disease comprised of chronic bronchitis and emphysema caused largely by smoking. Despite anti-smoking campaigns, COPD is the fastest growing major disease in the US and around the world. It affects nearly 13.5 million patients, and is now the third largest cause of death in the US and is expected to be the third leading cause in the world by 2020. Although there is no known cure for COPD, the disease is largely managed with inhaled bronchodilators and corticosteroids to improve lung function and reduce the frequency of exacerbations. Longer-acting agents and combinations have proven successful for treating many COPD patients, but the sicker and older segment of the COPD population (15-20 per cent) that requires nebulizer therapy are limited to shorter-acting agents and long treatment times resulting in reduced compliance and poor clinical outcomes.
Elevation Pharmaceuticals develops new inhaled therapies for patients with respiratory disease. The company’s initial focus is on developing novel therapies for the underserved population of COPD patients not able to effectively control their disease with dry powder or metered dose inhalers.
EP-101 is delivered by an eFlow Nebulizer System developed by PARI Pharma and optimized specifically for EP-101. The investigational eFlow Nebulizer System uses eFlow Technology to enable highly efficient aerosolization of medications via a vibrating, perforated membrane. Compared to other nebulization technologies, eFlow Technology produces aerosols with a very high density of active drug, a precisely defined droplet size, and a high proportion of respirable droplets delivered in the shortest possible period of time. Combined with its quiet mode of operation, small size, light weight, and battery use, eFlow Technology reduces the burden of taking daily, inhaled treatments.