Theravance Announces Initiation of Phase 2b Study With TD-4208, an Investigational LAMA for the Treatment of COPD

Theravance, Inc.

announced the initiation of the dose-ranging Phase 2b Study 0117 with TD-4208 as a nebulized aqueous solution in patients with moderate to severe chronic obstructive pulmonary disease (COPD). TD-4208 is an investigational inhaled long-acting muscarinic antagonist (LAMA), discovered using Theravance's multivalent approach to drug design. "We are very pleased with the progression of TD-4208 into a Phase 2b study in patients with COPD," said Mathai Mammen, M.D., Ph.D., Senior Vice President of Research and Development. "We believe we have a significant opportunity to meet the needs of certain patients who may need or prefer nebulized therapy." About the Phase 2b Study 0117 The Phase 2b study will evaluate the bronchodilator effect, safety and tolerability of four doses of TD-4208 and placebo in patients with moderate to severe COPD. Approximately 350 patients will be randomized to receive one of four doses of TD-4208 inhalation solution (44 mcg, 88 mcg, 175 mcg, 350 mcg) or placebo once daily via a jet nebulizer for 28 days in a double-blind, parallel group study design. The primary endpoint of the study is trough forced expiratory volume in one second (FEV1) after the 28-day treatment period. Secondary endpoints include measurements of serial FEV1 on Day 28 and Day 1 and safety and tolerability assessments. About TD-4208 and the LAMA Program TD-4208 is an inhaled LAMA discovered by Theravance through the application of multivalent design in a drug discovery program dedicated to finding new medicines for respiratory diseases such as COPD and asthma. In preclinical studies, TD-4208 has demonstrated high specificity for muscarinic receptors, sustained activity in the lung after inhalation, and minimal systemic effects. The goal of Theravance's LAMA program is to develop a once-daily inhaled medicine in a nebulizer for the treatment of a subset of COPD patients who are underserved by current hand held products or prefer nebulized therapy. TD-4208 has previously completed a multiple-dose Phase 2b Study (0091) and a single-dose Phase 2a study in patients with moderate to severe COPD.