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Eying Phase 3 after positive Phase 2 TD-9855 results
September 2018
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DUBLIN—August saw news from Theravance Biopharma Inc. of positive four-week results from its Phase 2 clinical trial of TD-9855 in patients with symptomatic neurogenic orthostatic hypotension (nOH). Patients saw durable improvements in their disease symptom severity after four weeks as measured by the Orthostatic Hypotension Symptom Assessment Question #1, with those in the extension phase of the study demonstrating a mean symptom improvement of 2.4 points at the four-week mark. TD-9855 also led to increased systolic blood pressure, with clinically meaningful increases in standing systolic blood pressure. No drug-related serious adverse events were reported, and the drug was generally well tolerated. Theravance reported that it has completed its talks with the FDA with regards to a pivotal Phase 3 registrational program for TD-9855 and intends to kick off the program late this year or in early 2019.

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