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Theravance Biopharma to Present New Ampreloxetine Data in Neurogenic Orthostatic Hypotension at the 33rd International Symposium on the Autonomic Nervous System
DUBLIN, Oct. 25, 2022 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) today announced new ampreloxetine
About this update from Theravance Biopharma, Inc.
[{"type":"text","content":"DUBLIN, Oct. 25, 2022 /PRNewswire/ -- Theravance Biopharma, Inc. (\"Theravance Biopharma\" or the \"Company\") (NASDAQ: TBPH) today announced new ampreloxetine data in neurogenic orthostatic hypotension (nOH) will be presented at the 33rd International Symposium on the Autonomic Nervous System, a meeting of the American Autonomic Society, taking place November 2-5, 2022, in Maui, Hawaii.\n\n \n \n \n \n \n \n\n \nThe data include three consecutive platform presentations on Wednesday, November 2, 2022, starting at 11:15 AM Maui, HI (5:15 PM ET / 2:15 PM PT / 9:15 PM GMT):\nBiaggioni I, et al. Abstract 34 / Virtual Poster 106A phase 3, 22-week, multi-center, randomized withdrawal study of ampreloxetine in treating symptomatic neurogenic orthostatic hypotension\nKaufmann H, et al. Abstract 33 / Virtual Poster 117Blood pressure and pharmacodynamic response of ampreloxetine, a norepinephrine reuptake inhibitor, in patients with symptomatic neurogenic orthostatic hypotension\nFreeman R, et al. Abstract 30 / Virtual Poster 4 Longitudinal analysis of ampreloxetine for the treatment of symptomatic neurogenic orthostatic hypotension in subset of patients with multiple system atrophy\nAbout AmpreloxetineAmpreloxetine (TD-9855) is an investigational, Theravance Biopharma-discovered, potent, long-acting, once-daily norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA). Phase 3 results (Study 0170) showed a benefit to MSA patients in the study that was observed in multiple endpoints including Orthostatic Hypotension Symptom Assessment (OHSA) composite, Orthostatic Hypotension Daily Activities Scale (OHDAS) composite, Orthostatic Hypotension Questionnaire (OHQ) composite and OHSA #1. The Company held a Type C meeting with the FDA in June 2022 and agreed on a path to NDA filing with one new Phase 3 clinical study in MSA patients with symptomatic nOH. The Company plans to start the new Phase 3 study in early 2023, with a primary endpoint of Change in OHSA Composite Score.\nAbout Study 0170, a Phase 3 StudyStudy 0170 (NCT03829657) was a 22-week Phase 3 study comprised of a 16-week open-label period and a 6-week double-blind, placebo-controlled, randomized withdrawal period. The primary endpoint of treatment failure at week 6 was def...