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news.Theravance has initiated the dose-ranging Phase IIb trial 0117 of its investigational inhaled long-acting muscarinic antagonist (LAMA), TD-4208 as a nebulized aqueous solution in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
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TD-4208 is discovered using the company’s multivalent approach to drug design.
The trial will evaluate the bronchodilator effect, safety and tolerability of four doses of TD-4208 and placebo in patients with moderate to severe COPD.
About 350 patients will be randomized to receive one of four doses of TD-4208 inhalation solution (44mcg, 88mcg, 175mcg, 350mcg) or placebo once daily via a jet nebulizer for 28 days in a double-blind, parallel group study design.
The primary endpoint of the trial is trough forced expiratory volume in one second (FEV1) after the 28-day treatment period and the secondary endpoints include measurements of serial FEV1 on Day 28 and Day 1 and safety and tolerability assessments.
Theravance senior vice president of Research and Development Mathai Mammen said the company is happy with the progression of TD-4208 into a Phase IIb study in patients with COPD.
"We believe we have a significant opportunity to meet the needs of certain patients who may need or prefer nebulized therapy," Mammen said.
Image: TD-4208 is discovered using Theravance’s multivalent approach to drug design for treatment of COPD. Photo: courtesy of dream designs/ freedigitalphotos.net