Alkermes initiates Phase IIa COPD study

The Phase IIa study is designed to assess the efficacy, safety, tolerability and pharmacokinetics of ALKS 27 in approximately 24 patients with chronic obstructive pulmonary disease (COPD).

In this randomized, double-blind, cross-over, placebo-controlled study, patients will receive single administrations of three doses of ALKS 27 and placebo, each separated by a wash out period. The efficacy of ALKS 27 will be evaluated based on improvements in pulmonary function in patients with COPD, as measured by FEV1, a commonly used measure of lung function.

In addition, the Phase IIa study will explore the safety, tolerability and effects of ALKS 27 in combination with formoterol fumarate inhalation powder, a long-acting beta agonist already approved for the treatment of COPD. All patients will receive the combination dose following the randomized, double-blind, placebo-controlled portion of the study. Alkermes expects to report top-line results from the full study in the second half of 2009.

Elliot Ehrich, chief medical officer of Alkermes, said: We are excited to move forward with the ALKS 27 program, one of several proprietary product candidates in our advancing pipeline. By applying our Air technology to trospium, a molecule with established efficacy and a known safety profile, ALKS 27 offers the opportunity to create a new, patient-friendly approach for the treatment of COPD.