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Theravance Biopharma Presents Two New Ampreloxetine Analyses in Oral Session at the American Academy of Neurology 2025 Annual Meeting
Analyses from Randomized Controlled Trials Further Support the Target Engagement and Safety Profile of Ampreloxetine in Neurodegenerative Disease DUBLIN,
About this update from Theravance Biopharma, Inc.
[{"type":"text","content":"Analyses from Randomized Controlled Trials Further Support the Target Engagement and Safety Profile of Ampreloxetine in Neurodegenerative Disease\nDUBLIN, April 7, 2025 /PRNewswire/ -- Theravance Biopharma, Inc. (\"Theravance Biopharma\" or the \"Company\") (NASDAQ: TBPH) today announced new analyses from its previous Phase 3 program evaluating ampreloxetine, an investigational medicine for the treatment of symptomatic neurogenic orthostatic hypotension (nOH). Both analyses were presented as platform presentations at the 77th Annual Meeting of the American Academy of Neurology (AAN) Meeting, taking place April 5-9, 2025, in San Diego, California. Findings support ampreloxetine's highly selective mechanism of action, with a safety profile that suggests no worsening of supine hypertension.\n\n \n \n \n \n \n \n\n \nThe previous Phase 3 program of ampreloxetine, a selective norepinephrine reuptake inhibitor included two back-to-back Phase 3 trials in patients with symptomatic nOH in multiple system atrophy (MSA), Parkinson's Disease and pure autonomic failure (Study 0169, NCT03750552 and Study 0170, NCT03829657). Results from these studies were supportive of a registrational study in patients with nOH and MSA that is currently ongoing (CYPRESS, NCT05696717). Analyses presented at AAN describe ampreloxetine's pharmacodynamic effects over time, demonstrating durable target engagement and a physiological effect on blood pressure.\n\"There is a persistent unmet need for effective long-term treatments for nOH in patients with MSA. Inadequately treated nOH is associated with rapid functional decline, and many patients fail to respond despite trials of two to three different antihypotensive agents. Currently, there are no approved therapies that improve symptoms long-term, and all carry potential risk of supine hypertension. These new analyses provide evidence of ampreloxetine's highly selective mechanism of action and precise targeting of peripheral nerve activity to relieve symptoms of nOH,\" said Dr. Valeria Iodice, Honorary Associate Professor in Neurology, National Hospital for Neurology and Neurosurgery, UCL, London UK.1\nTargeted Mechanism of Action in Patients with nOH\nStudy 0169 enrolled patients with symptomatic nOH, as defined by a 4-point or greater score on a patient reported assessment (OHSA2 scale). Pharmacokinetic and pha...