Alkermes and Indevus Pharmaceuticals have announced the initiation of a Phase IIa clinical study of ALKS 27 in patients with chronic obstructive pulmonary disease (COPD). ALKS 27 is an inhaled formulation of trospium chloride based on Alkermes’ proprietary AIR pulmonary technology.
The study will assess the safety, tolerability, pharmacokinetics and efficacy of single doses of ALKS 27 and is designed to further define the clinical profile of ALKS 27 in patients with COPD.
"By combining our proprietary AIR technology and Indevus' trospium chloride, a molecule with a known safety profile and proven efficacy in an approved indication, we hope to bring forward a more patient-friendly treatment option for people with COPD,” Elliot Ehrich, chief medical officer of Alkermes, said.
In this double-blind, crossover study, patients will receive single administrations of two different dose levels of ALKS 27 and placebo, each separated by a washout period. The efficacy of ALKS 27 will be evaluated based on improvements in pulmonary function in patients with COPD.
This study follows the completion of a Phase I study that demonstrated that ALKS 27 was well-tolerated over a wide dose range, with no dose-limiting effects observed. Alkermes and Indevus expect to report top-line results from the study in the second half of 2007. The companies also plan to engage a partner for future development and commercialization of ALKS 27.