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Elevation Pharmaceuticals' investigational COPD therapy meets primary endpoint of Phase IIb trial

Wednesday, May 16 2012 | Comments
Evidence Grade 0 What's This?
Elevation Pharmaceuticals Inc.'s EP-101, an investigational once-daily inhalation solution formulation of glycopyrrolate, significantly improves lung function in patients with moderate to severe chronic obstructive pulmonary disease (COPD), according to data from a Phase IIb trial.

The GOLDEN-1 trial was a double-blind, crossover study that included 140 patients aged 40 to 75 years with moderate to severe COPD. The study compared four doses of EP-101 with placebo and two open-label active controls--Pfizer Inc. and Boehringer Ingelheim Pharmaceuticals Inc.'s Spiriva (tiotropium bromide monohydrate) inhalation powder and ipratropium bromide inhalation solution.

EP-101 and placebo were administered once daily using Pari Pharma GmbH's investigational handheld eFlow nebulizer device, Spiriva (18 mcg once daily) was administered with the Spiriva HandiHaler dry-powder inhaler and ipratropium bromide (500 mcg three times per day) was administered with a general purpose nebulizer.

All four doses of EP-101 met the primary endpoint of the trial, demonstrating superior improvements in lung function (assessed with 24-hour trough forced expiratory volume in one second) relative to placebo after seven days of treatment.

Elevation said that the complete results of the GOLDEN-1 trial will be presented at an upcoming medical conference. The firm is planning to initiate a second Phase IIb study in the fourth quarter to select the optimal dose of EP-101 for a pivotal Phase III program.

EP-101's active ingredient, glycopyrrolate, is a long-acting muscarinic antagonist. Elevation licensed the eFlow nebulizer device from Pari Pharma. The nebulizer was optimized specifically for EP-101 and enables "highly efficient" aerosolization of medications via a vibrating, perforated membrane, Elevation said, adding that this technology produces aerosols with a very high density of active drug, a precise droplet size and a high proportion of respirable droplets delivered in the shortest period of time.

This information concerns a use that has not been approved by the Food and Drug Administration.

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