Theravance Biopharma Completes Enrollment in Pivotal Phase 3 CYPRESS Study of Ampreloxetine.

Theravance Biopharma has completed enrollment in the pivotal Phase 3 CYPRESS study of Ampreloxetine for symptomatic neurogenic orthostatic hypotension due to Multiple System Atrophy. Topline results are expected in Q1 2026. If successful, the company plans to expedite the New Drug Application submission. Ampreloxetine has Orphan Drug Designation in the US, underscoring the unmet need in symptomatic nOH due to MSA. The drug has the potential to provide durable benefit for the 40,000 patients with symptomatic nOH in the US.

Theravance Biopharma, Inc. (NASDAQ: TBPH) has announced the completion of enrollment in the pivotal Phase 3 CYPRESS study of Ampreloxetine for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) due to multiple system atrophy (MSA). The study, which began in August 2025, marks a significant milestone in the development of Ampreloxetine, an investigational, once-daily, selective norepinephrine reuptake inhibitor.

The CYPRESS study is a global, randomized-withdrawal trial designed to evaluate the efficacy and durability of Ampreloxetine in patients with symptomatic nOH due to clinically diagnosed MSA. The study enrolled patients across four continents and included a 12-week open-label period, followed by an eight-week randomized-withdrawal period. The primary endpoint of the study is the change in orthostatic hypotension symptom assessment (OHSA) composite score from randomized-withdrawal baseline to Week 8.

The company expects to report topline data from the Phase 3 CYPRESS trial in Q1 2026. If the results are supportive, Theravance plans to expedite the New Drug Application (NDA) submission, potentially requesting priority FDA review. The company's strategic focus on advancing high-impact catalysts is reflected in this milestone, as previously highlighted in its recent Q2 earnings call.

Ampreloxetine has received Orphan Drug Designation in the US, underscoring the unmet need in symptomatic nOH due to MSA. The drug has the potential to provide durable benefit for the estimated 40,000 patients in the US with symptomatic nOH in patients with MSA. The company's commitment to delivering Medicines that Make a Difference® is evident in its pursuit of this therapy.

References:
[1] https://www.morningstar.com/news/pr-newswire/20250825sf57834/theravance-biopharma-completes-enrollment-in-pivotal-phase-3-cypress-study-of-ampreloxetine-in-patients-with-symptomatic-neurogenic-orthostatic-hypotension-due-to-multiple-system-atrophy