Theravance has commenced Phase 2b study desined to evaluate varying doses of TD-4208 in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Theravance leveraged its multivalent approach of drug design to discover the investigational inhaled long-acting muscarinic antagonist TD-4208.
Theravance research and early clinical development senior vice president Mathai Mammen said few patients might prefer long-acting medicines delivered in the aqueous nebulised platform over handheld inhalation devices.
"In addition, TD-4208 may offer these patients the convenience of once-a-day dosing compared to currently nebulised medicines which must be dosed multiple times daily," Mammen added.
The study will assess the bronchodilatory effect, pharmacokinetics, safety and tolerability profiles of 22mcg, 44mcg, 88mcg, 175mcg, 350mcg or 700mcg doses of TD-4208 compared to placebo in approximately 60 subjects.
As per the incomplete crossover study design, patients will be randomised once each day with varying doses of TD-4208 or placebo using a nebuliser for over five study periods each lasting for seven days.
Trough forced expiratory volume in one second (FEV1) measured after the seventh dose of every treatment period is the primary endpoint of the study while the secondary endpoints include measurements of FEV1: Peak and area under the curve from 0 to 24 hours (AUC0-24), AUC0-12, and AUC12-24 after the seventh dose of every treatment period.
