Theravance Biopharma, Inc. Announces Ampreloxetine Presentations At the International MSA Congress

Published: 2025-05-09 12:00:00 ET TBPH

Published on 05/09/2025 at 12:00, updated on 05/09/2025 at 13:05

Theravance Biopharma, Inc. 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. A 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: Patients 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.

The unique benefits of ampreloxetine treatment reported in MSA patients from Study 0170 included an increase in norepinephrine levels, a favorable impact on blood pressure, clinically meaningful and durable symptom improvement, and no signal for worsening of supine hypertension. In the US, the Company has been granted an Orphan Drug Designation for ampreloxetine for the treatment of symptomatic nOH in patients with MSA and, if results from the ongoing Phase 3 CYPRESS study are supportive, plans to file an NDA for full approval in this indication.