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Theravance Announces Positive Results from a Phase 2a Study of TD-4208
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Theravance, Inc. has announced positive topline results from a Phase 2a single-dose study of TD-4208, an investigational inhaled long-acting muscarinic antagonist (LAMA), discovered using Theravance's multivalent approach to drug design.
This compound is under development by Theravance for the treatment of chronic obstructive pulmonary disease (COPD).
In this study, TD-4208 met the primary endpoint by demonstrating a statistically significant mean change from baseline in peak forced expiratory volume in one second (FEV1) compared to placebo and was generally well tolerated.
"We are encouraged by these positive Phase 2a results, which support further development of TD-4208 in COPD," said Mathai Mammen, Sr. Vice President, Research and Early Clinical Development of Theravance.
Mammen continued, "We designed TD-4208 to be a multivalent antagonist with high specificity for muscarinic receptors, sustained activity in the lung after inhalation, and minimal effects outside of the lung. We are excited that our core technology continues to yield promising clinical candidates for patients with significant medical needs."
In the recently completed Phase 2a study, both doses of TD-4208 (350 mcg and 700 mcg) and the active control ipratropium bromide (500 mcg, the marketed dose), each administered via nebulizer, demonstrated a statistically significant improvement in peak FEV1 versus placebo of 174 mL (95% Confidence Interval (CI): 112, 235), 169 mL (95% CI: 108, 231) and 176 mL (95% CI: 114, 237), respectively, with p < 0.001.
All three treatments demonstrated a rapid and similar onset of action. In a secondary analysis, both doses of TD-4208 demonstrated a long duration of action with statistically significant effect at 24 hours.
The mean changes from baseline in FEV1 compared to placebo at 24 hours were 103 mL and 137 mL for 350 mcg and 700 mcg of TD-4208, respectively. As expected, ipratropium bromide did not produce significant effects versus placebo at 12 hours and 24 hours.
Both doses of TD-4208 were generally well tolerated in the study with an incidence of adverse events similar to those for ipratropium bromide and placebo and with no clinically significant increase in heart rate or evidence of dry mouth.
Adverse events were generally mild and occurred in all treatment and placebo groups with the most common adverse events being headache and dyspnea.
There were no serious adverse events reported in the study. The full results of the study will be presented at an upcoming medical conference.
