GlaxoSmithKline initiates Phase II trial for COPD treatment

The Phase II double-blind, randomized study is designed to evaluate the safety and efficacy of GSK961081 doses administered once daily for 14 days in a dry powder inhaler. Approximately 40 patients will be randomized to receive the drug dosed once-daily; salmeterol dosed twice-daily plus tiotropium dosed once-daily; or placebo, in this crossover design study.

The goal of this program is to develop a once-a-day medicine with improved efficacy relative to existing therapies of inhaled beta2-adrenoceptor agonists and anti-muscarinic drugs used for the treatment of chronic obstructive pulmonary disease (COPD).

The bifunctional muscarinic antagonist-beta2 agonist compound was discovered by Theravance and is being developed by GlaxoSmithKline under an agreement between the companies.

Michael Kitt, senior vice president of development at Theravance, said: “By combining the activities of the two approaches to COPD treatment, along with high lung selectivity, in one MABA compound, we aim to develop a medicine with greater efficacy than single mechanism bronchodilators, such as tiotropium or salmeterol, and with equal or better tolerability.”