Alkermes Inc. and Indevus Pharmaceuticals, Inc. has announced that they have entered into a joint collaboration for the development of ALKS 27, an inhaled formulation of trospium chloride for the treatment of chronic obstructive pulmonary disease (COPD).
The announcement of this collaboration follows the completion of extensive feasibility work, preclinical studies and a phase 1 study in healthy volunteers. Preliminary results from the phase 1 study showed that ALKS 27 was well tolerated over a wide dose range, with no dose-limiting effects observed.
The phase 1 randomised, double-blind, placebo-controlled study was designed to assess the safety, tolerability, and pharmacokinetics of ALKS 27 in 20 healthy, non-smoking adults. Subjects were given single escalating inhaled administrations of ALKS 27 at dose levels ranging from 50 mcg to 800 mcg. The study results showed that ALKS 27 was well tolerated over a wide dose range, with no dose-limiting effects observed. Evaluation of the pharmacokinetic data indicated that exposure was dose-related.
"We are encouraged by the early data on ALKS 27 and are pleased to be working with Indevus to develop a new product candidate for the treatment of COPD, a serious and underserved disease," stated Richard Pops, chief executive officer of Alkermes. "ALKS 27 combines our proprietary AIR technology with Indevus' trospium chloride, a molecule with a known safety profile and proven efficacy in certain spasmodic indications. In addition, there exists an established regulatory path for inhaled COPD medications that serves as a basis for advancing the ALKS 27 programme in the clinic."
"We believe that these phase 1 results support the rationale for the ALKS 27 programme, which combines Alkermes' AIR pulmonary drug delivery technology and the unique properties of our compound to create a new approach for the treatment of COPD," stated Glenn L Cooper, MD., chairman, and chief executive officer of Indevus. "We very much look forward to continuing to collaborate with Alkermes through phase 2a, and working together to secure a partner to bring forward an exciting new therapy in the COPD market."
Alkermes and Indevus plan to initiate a phase 2a clinical study in the first half of 2007 designed to evaluate the clinical efficacy of ALKS 27, administered once-daily, in subjects with COPD. Pending results of the phase 2a study, the companies plan to engage a partner for future development and commercialisation of ALKS 27.
Under the joint collaboration, Alkermes and Indevus have shared and continue to share equally all costs of development and commercial returns on a worldwide basis. Alkermes will perform all formulation work and manufacturing. Indevus will conduct the clinical development programme. Additional terms of the agreement were not disclosed.
ALKS 27 is an inhaled formulation of trospium chloride, a muscarinic receptor antagonist that relaxes smooth muscle tissue and has the potential to improve airflow in patients with COPD. Trospium chloride is the active ingredient in Sanctura Indevus' currently marketed product for overactive bladder. The formulation under development for ALKS 27 is specifically designed for inhalation utilizing Alkermes' proprietary AIR pulmonary delivery system.
Chronic obstructive pulmonary disease (COPD), characterized by airflow obstruction and loss of expiratory force, comprises mostly smoking-related diseases such as emphysema and chronic bronchitis.