Theravance has begun a TD-4208 dose ranging Phase IIb study in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).
Investigational inhaled long-acting muscarinic antagonist (LAMA) TD-4208, discovered using Theravance’s multivalent approach to drug design, is under development for the treatment of COPD.
Theravance research and early clinical development senior vice president Dr Mathai Mammen said some patients may prefer long-acting medicines delivered in the aqueous nebulised platform used in the study 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 said.
The Phase IIb study is designed to assess the bronchodilatory effect, pharmacokinetics and safety and tolerability of multiple doses of TD-4208 in COPD patients.
Around 60 patients are expected to be randomised with 22mcg, 44mcg, 88mcg, 175mcg, 350mcg or 700mcg doses of TD-4208 and placebo once each day through a nebuliser over five seven-day study periods in an incomplete crossover study design.
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Trough forced expiratory volume in one second (FEV1) after the seventh dose of each treatment period is the primary endpoint of the study.
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 each treatment period.
According to the preclinical study data, TD-4208 exhibited high specificity for muscarinic receptors, sustained activity in the lung after inhalation and minimal effects outside of the lung.