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news.Theravance has reported positive Phase 2a study results of its investigational inhaled long-acting muscarinic antagonist (LAMA) - TD-4208.
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The aim of the double-blind, randomized and four-period study was to assess the bronchodilatory effect, pharmacokinetics, safety and tolerability of single inhaled doses of TD-4208 in patients with chronic obstructive pulmonary disease (COPD).
The trial enrolling 32 patients recieved TD-4208 (350 mcg and 700 mcg), ipratropium bromide and placebo, each administered as single doses via a nebulizer.
The study met the primary endpoint with a mean change from baseline in peak forced expiratory volume in one second (FEV1) compared to placebo.
The study also met the secondary endpoints, including the drug’s safety and tolerability.
Theravance Research and Early Clinical Development senior vice president Mathai Mammen said they are encouraged by these positive Phase 2a results which support further development of TD-4208 in COPD.