Theravance Biopharma Completes Enrollment in Pivotal Phase 3 CYPRESS Study of Ampreloxetine in Patients with Symptomatic Neurogenic Orthostatic Hypotension due to Multiple System Atrophy

Core Insights - Theravance Biopharma has completed enrollment in the pivotal Phase 3 CYPRESS study for ampreloxetine, targeting symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA) [1][3][5] - nOH affects approximately 80% of MSA patients, leading to severe symptoms and a lack of effective treatment options [1][8] - The CYPRESS study aims to evaluate the efficacy and safety of ampreloxetine, with topline data expected in Q1 2026 [3][5] Company Overview - Theravance Biopharma focuses on developing innovative therapies, including ampreloxetine, a selective norepinephrine reuptake inhibitor for nOH in MSA patients [4][9] - The company has received Orphan Drug Designation for ampreloxetine in the U.S., highlighting the unmet medical need in this patient population [5][9] Study Details - The CYPRESS study is a global, randomized-withdrawal trial assessing ampreloxetine's impact on nOH symptoms, with a primary endpoint of change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score [2][6] - The study includes a 12-week open-label phase followed by an 8-week randomized withdrawal phase [2][6] Market Context - There are approximately 40,000 patients in the U.S. suffering from symptomatic nOH due to MSA, indicating a significant market opportunity for effective treatments [2][5] - Current therapies for nOH often fail to provide lasting relief and have safety concerns, underscoring the need for new solutions like ampreloxetine [2][3]