Elevation Pharmaceuticals has announced that a Phase 2b study of its EP-101 glycopyrrolate inhalation solution in patients with moderate to severe COPD demonstrated that EP-101 produced statistically significant improvement in lung function compared to placebo after 7 days.
The GOLDEN-1 (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer) study of EP-101 in 140 patients showed superior efficacy for EP-101 versus placebo at all doses tested. According to the company, EP-101 was well-tolerated with comparable side effects to placebo, Spiriva Handihaler, and three times daily nebulized ipratropium bromide. Delivery of EP-101 by an eFlow nebulizer licensed from PARI Pharma took less than 3 minutes and produced onset of action within about 5 minutes.
“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. 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,” commented Elevation President and CEO Bill Gerhart.
Elevation Chief Medical Officer Ahmet Tutuncu said, “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. 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.”
The company plans to begin another Phase 2b study in the fourth quarter of 2012.
Read the Elevation press release.
