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Theravance Biopharma, Inc. Announces Top-line Results from a Phase 3 Study of Ampreloxetine in Patients with Symptomatic Neurogenic Orthostatic Hypotension
- Randomized, double-blind, placebo-controlled study did not meet the primary endpoint: improvement in OHSA #1 in patients receiving ampreloxetine for four
About this update from Theravance Biopharma, Inc.
[{"type":"text","content":"- Randomized, double-blind, placebo-controlled study did not meet the primary endpoint: improvement in OHSA #1 in patients receiving ampreloxetine for four weeks compared to placebo\n\n\nDUBLIN and SOUTH SAN FRANCISCO, Calif., Sept, 15, 2021 /PRNewswire/ -- Theravance Biopharma, Inc. (\"Theravance Biopharma\" or the \"Company\") (NASDAQ: TBPH), a diversified biopharmaceutical company primarily focused on the discovery, development, and commercialization of organ-selective medicines, today announced top-line results from a Phase 3 randomized, double-blind, placebo-controlled multi-center Phase 3 study assessing the safety and efficacy of ampreloxetine compared to placebo for the treatment of symptomatic neurogenic orthostatic hypotension (nOH). \n\n \n \n \n \n \n \n\n \nThe study did not meet its primary endpoint. The majority of treatment-related adverse events were mild or moderate in severity. Serious adverse events occurred in two patients on placebo and four on ampreloxetine and none were considered related to the study drug; no deaths were reported. There was no signal for supine hypertension. The Company plans to present the results at a future scientific forum.\n\"These are not the results we had hoped to achieve, especially given the clear unmet need for patients suffering from symptomatic nOH and the positive top-line four-week results from the Phase 2 study announced in 2018. We will continue to analyze the data to better understand the findings,\" said Rick E Winningham, Chief Executive Officer, Theravance Biopharma. \"We are grateful to all those who dedicated their time and efforts to progress this study, especially during the challenges of the pandemic. We are hopeful that insights from this study may inform future drug development to help those with this debilitating condition.\"\nIn light of these results, the Company will be determining the appropriate next steps for Study 0170 (NCT03829657; more than 75% enrolled) and Study 0171 (NCT04095793); clinical trial sites will be notified accordingly.\nAbout the Phase 3 Study \nStudy 0169 (NCT03750552) was a Phase 3, 4-week, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of ampreloxetine compared to placebo in patients with symptomatic nOH (n=195). Patients from Study 0169 were eligible to enter into Study 0170, ...