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Elevation Pharmaceuticals Presents Positive Phase 2b Results for EP-101 in COPD Patients at the European Respiratory Society Annual Congress
Date:9/2/2012

  EP-101 was well tolerated at all doses, and the incidence of adverse events was generally similar to placebo and to ipratropium but tended to be higher than treatment with tiotropium.  The most commonly reported adverse events were cough and headache with no dose relationship for the incidence of adverse events.  One death was reported in the study in a patient treated with EP-101, but this death was considered to be unrelated to study treatment.

"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," said Dr. Ahmet Tutuncu, Senior Vice President and Chief Medical Officer of Elevation Pharmaceuticals. 

LAMAs are preferred for patients with more severe COPD, and EP-101 is believed to be the only nebulized LAMA in clinical development.  EP-101 is being developed in combination with an Investigational eFlow device – a portable nebulizer providing targeted lung delivery and short treatment times – to significantly improve the standard of care for the large underserved subpopulation of COPD patients not adequately treated by dry powder or metered dose inhalers.

A second Phase 2b study will be initiated in Q4 2012 to select the dose for Phase 3 studies, which are expected to start in the second half of 2013.

About COPD
COPD is a slow progressive disease comprising chronic bronchitis and emphysema caused largely by smoking. COPD is the fastest growing major disease in the U.S. and around the world.  Affecting nearly 14.8 million patients and an additional 12 million undiagnosed patients, COPD is now the third leading cause of death in the U.S. and is expected to be the third leading cause in the world by 2020.  The disease is largely managed with inhaled bronchodilators, and as the course of disease progresses, inhaled corticosteroids ma
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SOURCE Elevation Pharmaceuticals, Inc.
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