EP-101 is Elevation’s lead product candidate for the treatment of chronic obstructive pulmonary disease (COPD). EP-101 is a proprietary solution formulation of glycopyrrolate, a long-acting muscarinic antagonist (LAMA), delivered by a customized eFlow® Nebulizer System (PARI Pharma GmbH), which allows for ease of use and optimized medication delivery.
COPD patients who cannot effectively operate or benefit from a dry powder or metered dose inhaler are prescribed nebulized medicines. These COPD patients with more severe disease can receive a full dose with a nebulizer, regardless of their disease state, because all that is required to receive a full dose is tidal (normal) breathing. However, medicines currently available for nebulization require 2-4 doses per day and long treatment times (10-15 minutes per dose) using conventional table top jet nebulizers, often leading to poor compliance and thus poor clinical outcomes. Additionally, LAMAs are considered first-line therapy for moderate-to-severe COPD, but there are no LAMA formulations available for nebulization.
EP-101 can be the first LAMA approved for a nebulizer, and it is being developed in combination with an investigational eFlow device – a portable, easy-to-use nebulizer that provides a treatment time of only a few minutes – significantly improving the standard of care for the large underserved subpopulation of COPD patients not adequately treated by conventional inhalers or nebulizers.
EP-101 Phase 2a Study Results
Our Phase 2a study, (EP-101-02), demonstrated a statistically significant and well-tolerated improvement in lung function over the 24-hour time period post dosing for EP-101 versus placebo. Click here for the complete results of our Phase 2a study.
EP-101 Phase 2b Study Ongoing
Elevation’s Phase 2b study, GOLDEN-1, is a randomized, double-blind, placebo-controlled, 7-day dosing study to assess the dose-response, safety, and efficacy of EP-101 in subjects with moderate to severe COPD. Click here for information about this multi-center clinical trial.