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.
COPD is a serious, chronic disease characterized by a gradual loss of lung function and affects more than 12 million adults in the U.S.(1) As an inhaled formulation of trospium chloride, a muscarinic receptor antagonist that relaxes smooth muscle tissue, ALKS 27 could potentially improve airflow and provide a new treatment option for patients with COPD.
"The advancement of ALKS 27 in the clinic is an important step forward for the program," stated Elliot Ehrich, Chief Medical Officer of Alkermes.
"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," Ehrich continued.
"ALKS 27 offers the opportunity to create a new approach for the treatment of COPD, an underserved disease that affects millions of people each year," stated Glenn L. Cooper, M.D., Chairman and CEO of Indevus. "We look forward to continuing to collaborate with Alkermes on the clinical development of ALKS 27."
The phase 2a study is designed to assess the safety, tolerability, pharmacokinetics and efficacy of ALKS 27 in twenty-four patients with COPD. In this double-blind, cross-over study, patients will receive single administrations of two different dose levels 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. This phase 2a study follows completion of a phase 1 study which 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.
Alkermes and Indevus currently plan to engage a partner for future development and commercialization of ALKS 27.