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Theravance Reports Results from Phase 2B Study 0091 with TD-4208 for COPD, Says Met Primary Efficacy Endpoint

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Theravance, Inc. (NASDAQ: THRX) today announced positive topline results from a dose-ranging 7-day cross-over design Phase 2b study of TD-4208, an investigational long-acting muscarinic antagonist (LAMA), administered once-a-day as a nebulized aqueous solution in patients with moderate to severe chronic obstructive pulmonary disease (COPD). The primary efficacy endpoint in this study was change from baseline in trough FEV1 (forced expiratory volume in one second) at the end of Day 7.

"We are very pleased with the positive results of the Phase 2b study of TD-4208 in patients with COPD," said Mathai Mammen, M.D., Ph.D., Senior Vice President of Research and Early Clinical Development. "We are encouraged that we have identified doses of TD-4208 that provide clinically meaningful levels of bronchodilation, as well as lower doses that do not. Additionally, TD-4208 demonstrated a 24 hour profile consistent with a once-a-day regimen."

TD-4208 met the primary efficacy endpoint for all six doses studied (ranging from 22 mcg to 700 mcg), and demonstrated a statistically significant change versus placebo from baseline in trough FEV1. The dose of 175 mcg was identified as the lowest that demonstrated a clinically meaningful change in FEV1 versus placebo at trough of 114 mL (95% CI: 76,153).

Serial FEV1 measurements over 24 hours on Day 7 demonstrated comparable bronchodilation over the first (0-12 hours) and second (12-24 hours) 12-hour periods. TD-4208 demonstrated a low peak to trough ratio for TD-4208 consistent with a once-a-day dosing regimen. TD-4208 pharmacokinetics demonstrated low (sub-pharmacologic) and predictable systemic exposure following dosing.

All doses of TD-4208 were generally well tolerated in the study with rates of adverse events comparable to placebo. The most common adverse events were headache, cough, and dyspnoea. Review of laboratory panels revealed no abnormal trends. There were no placebo-adjusted increases in heart rate or any ECG parameter at any of the doses at any time point. In addition, there were no discontinuations from the study attributed to adverse events related to study drug. Three patients experienced serious adverse events: one on placebo and two on TD-4208 22 mcg, none of which were considered to be treatment related.

Posted-In: News FDA


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