Theravance Announces Initiation of Phase 2 Clinical Program with its MABA Compound in COPD
Wednesday October 31, 4:05 pm ET
SOUTH SAN FRANCISCO, CA--(MARKET WIRE)--Oct 31, 2007 -- Theravance, Inc. (NasdaqGM:THRX - News) announced today that GSK has initiated a Phase 2 clinical study of GSK961081, an investigational bifunctional muscarinic antagonist-beta2 agonist compound for the treatment of chronic obstructive pulmonary disease (COPD). The compound was discovered by Theravance and is being developed by GlaxoSmithKline plc (GSK) under the parties' Strategic Alliance Agreement.
GSK961081 ('081) is a potent, long-acting, inhaled bronchodilator featuring a bifunctional mechanism of action, combining both muscarinic antagonist and beta2 agonist pharmacology in a single molecule. 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 COPD.
GSK initiated the Phase 2 study based upon favorable data from pre-clinical and Phase 1 studies completed earlier this year. In Phase 1 randomized double-blind, placebo-controlled, single- and multiple-dose studies that enrolled healthy volunteers, '081 was generally well tolerated and demonstrated evidence of bronchodilation over 24 hours after a single dose and after seven consecutive daily doses.
The Phase 2 double-blind, randomized, study is designed to evaluate the safety and efficacy of '081 doses administered once daily for 14 days in a dry powder inhaler. Approximately 40 patients will be randomized to receive '081 dosed once daily, salmeterol dosed twice daily plus tiotropium dosed once daily, or placebo in this crossover design study.
"Currently some patients with COPD are using a combination of both an inhaled muscarinic antagonist and an inhaled beta2 agonist," said Michael Kitt, MD, Senior Vice President of Development at Theravance. "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. We look forward to further exploring in Phase 2 the potential of this compound to provide a better treatment option for the many patients who suffer from obstructive pulmonary disease." |
