Completion of Enrollment in Phase 3 Cypress Study for Ampreloxetine

By Greg Peters • Monday, August 25 15:33 • Permanent Link

Theravance Biopharma, Inc. has recently announced the completion of enrollment in the open-label portion of its pivotal phase 3 Cypress study in patients with symptomatic neurogenic orthostatic hypotension (NOH) due to multiple system atrophy (MSA). The phase 3 Cypress study is a global, randomized-withdrawal study evaluating ampreloxetine in patients with symptomatic NOH due to clinically diagnosed MSA.

The company expects to report topline data from the phase 3 Cypress trial in Q1 2026 and is preparing for an expedited NDA submission following the results. Ampreloxetine, an investigational, once-daily, selective norepinephrine reuptake inhibitor, has been granted an orphan drug designation in the US for the treatment of symptomatic NOH in patients with MSA and, if results from the ongoing phase 3 Cypress study are supportive, the company plans to file an NDA for full approval in this indication.

Ampreloxetine has shown compelling improvement in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score without worsening supine hypertension in a previous study. The primary endpoint of the Cypress study is the change in OHSA composite score from randomized-withdrawal baseline to week 8.

Theravance Biopharma is focused on delivering medicines that make a difference in people's lives. The company's late-stage investigational once-daily norepinephrine reuptake inhibitor, ampreloxetine, has the potential to be a first-in-class therapy effective in treating a constellation of cardinal symptoms in MSA patients.

The completion of enrollment in the pivotal phase 3 Cypress study represents a significant step toward bringing a potentially transformative therapy to patients with symptomatic NOH due to MSA, addressing an underserved patient population in dire need of new, effective, and durable treatment options with a favorable safety profile. As a result of these announcements, the company's shares have moved -0.32% on the market, and are now trading at a price of $13.865. For more information, read the company's full 8-K submission here.

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