July 15, 2008

Theravance Reports Encouraging Results From Phase I COPD Trial

Theravance has announced the positive results from a Phase I study designed to assess the safety, tolerability and pharmacokinetics of an investigational inhaled long-acting muscarinic antagonist, GSK1160724/TD-4208, for the treatment of chronic obstructive pulmonary disease.

In the study, TD-4208 was generally well tolerated with a similar incidence of adverse events to placebo and there was no significant increase in heart rate or evidence of dry mouth. Abnormal taste was reported at the higher doses. Additionally, TD-4208 demonstrated evidence of bronchodilation in volunteers sensitive to muscarinic antagonists.

The Phase I clinical study was a single-dose randomized, crossover, incomplete block, double-blind, placebo- and active-controlled study designed to evaluate the safety, tolerability and pharmacokinetics of multiple doses of TD-4208.

A total of 20 healthy volunteers were randomized to receive TD-4208 dosed once daily, tiotropium dosed once daily, or placebo. The primary endpoint of this study was overall safety and tolerability of TD-4208.

Rick Winningham, CEO of Theravance, said: "We are encouraged by these Phase I results which showed that TD-4208 dosed once daily was generally well tolerated. There is a large underserved COPD patient population that needs better long-acting treatment options."