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Theravance Biopharma Announces Ampreloxetine Presentations at the International MSA Congress
DUBLIN, May 9, 2025 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) today announced presentation of
About this update from Theravance Biopharma, Inc.
[{"type":"text","content":"DUBLIN, May 9, 2025 /PRNewswire/ -- Theravance Biopharma, Inc. (\"Theravance Biopharma\" or the \"Company\") (NASDAQ: TBPH) today announced presentation of analyses of its previous Phase 3 program evaluating ampreloxetine, an investigational medicine for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) at the International MSA Congress, taking place May 9-11 in Boston, Massachusetts.\n\n \n \n \n \n \n \n\n \nA subgroup analysis selected as a platform presentation focused on patients with Multiple System Atrophy (MSA) in the REDWOOD 0170 study (NCT03829657), an international phase 3, placebo-controlled, double-blind, randomized withdrawal trial, designed to demonstrate clinical worsening in those assigned to placebo. This analysis concluded:\nPatients with MSA showed clinically meaningful improvement in their nOH symptoms as measured by the OH Symptom Assessment (OHSA) composite score after 16 weeks of open-label treatment with ampreloxetine. After week 6 of randomization, symptoms remained stable in the ampreloxetine group and worsened in the placebo group.Ampreloxetine treatment was associated with an improvement in functional activities, such as standing or walking for a short time, which was lost after withdrawal to placebo.The clinical, cardiovascular and neuroendocrine profile of ampreloxetine showed target engagement of residual peripheral autonomic neurons and a sustained standing blood pressure effect, which is consistent with the profile of a selective norepinephrine reuptake inhibitor.An additional analysis from Study 0169 (NCT03750552) presented at the Congress showed that despite treatment with available nOH medications, patients with MSA had the highest nOH symptom burden on entry, which highlights the substantial unmet need for better nOH therapies in this population.\nResults from these studies were supportive of the current registrational study in patients with nOH and MSA that is currently ongoing (CYPRESS, NCT05696717).\n\"Patients with MSA often experience severe symptoms and impact to their quality of life due to nOH, and we are motivated to reduce this burden to patients and their caregivers,\" said Dr. Lucy Norcliffe-Kaufmann, Theravance Biopharma's Executive Director of Clinical Science. \"As supported by a clinically-validated measure of patient well-being over 16 to 22 weeks of ther...