Theravance Announces Positive Results From Phase 2b Study Of COPD Drug TD-4208

(RTTNews) - Theravance, Inc. (THRX) on Wednesday announced positive topline results from a dose-ranging 7-day cross-over design Phase 2b study of TD-4208, an investigational long-acting muscarinic antagonist, administered once-a-day as a nebulized aqueous solution in patients with moderate to severe chronic obstructive pulmonary disease.

The primary efficacy endpoint in the study was change from baseline in trough FEV1, or forced expiratory volume in one second, at the end of Day 7.

TD-4208 met the primary efficacy endpoint for all six doses studied, and showed a statistically significant change compared to placebo from baseline in trough FEV1.

Serial FEV1 measurements over 24 hours on Day 7 demonstrated comparable bronchodilation over the first and second 12-hour periods. TD-4208 demonstrated a low peak to trough ratio for TD-4208 consistent with a once-a-day dosing regimen.