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Theravance Biopharma Completes Enrollment in Phase 3 CYPRESS Study

Overview

Theravance Biopharma, Inc., a company focused on advancing treatments for rare and complex diseases, announced the completion of patient enrollment in its pivotal Phase 3 CYPRESS study. This study evaluates the efficacy of ampreloxetine, an investigational drug for patients suffering from symptomatic neurogenic orthostatic hypotension (nOH) associated with multiple system atrophy (MSA). This announcement marks a significant advance in clinical trials aimed at addressing a critical and unmet medical need.

Understanding nOH and MSA

Neurogenic orthostatic hypotension (nOH) is a debilitating condition that affects many patients diagnosed with multiple system atrophy (MSA), a rare neurodegenerative disorder that progressively impacts movement and balance. It results in substantial drops in blood pressure upon standing, leading to symptoms such as dizziness, lightheadedness, and even fainting. Approximately 80% of patients with MSA experience some degree of nOH, indicating a dire need for effective treatment options.

The Importance of Ampreloxetine

Ampreloxetine is designed to directly address the underlying cause of nOH by selectively inhibiting norepinephrine reuptake. This innovative approach aims to provide a more durable benefit compared to existing treatments which often require multiple dosing schedules and can exacerbate conditions like supine hypertension. Dr. Horacio Kaufmann, a respected neurologist, emphasized the potential of ampreloxetine to significantly improve patient outcomes by attending to the core issues associated with nOH in MSA patients.

Study Design and Goals

The Phase 3 CYPRESS study is a global, multicenter examination that includes a randomized-withdrawal design. Initially, participants were enrolled in a 12-week open-label phase, followed by randomization where responders were split to continue with ampreloxetine or switch to placebo for eight weeks. The primary measure of efficacy is the change in orthostatic hypotension symptom assessment (OHSA) composite score from the baseline to the end of the randomized-withdrawal phase.

Completing the enrollment phase is a critical milestone that paves the way for analyzing data expected in early 2026. This data will be fundamental in determining the drug’s potential as a new treatment option for this vulnerable patient population.

The Road Ahead

Theravance Biopharma is poised to file for expedited approval with the FDA should the trial results prove favorable. Their aim is to provide the first effective long-term treatment for nOH tied to MSA, establishing ampreloxetine as a groundbreaking therapy that addresses the symptoms faced by these patients. The company’s commitment to innovation in treating MSA and nOH signifies their strategic focus on high-impact medical advancements.

With notable insights gathered from previous studies, the CYPRESS trial stands to offer a thorough understanding of ampreloxetine's efficacy and durability. Patients, healthcare providers, and stakeholders await the results that could change the landscape of treatment for neurogenic orthostatic hypotension in MSA patients forever.

Conclusion

The successful completion of enrollment in the CYPRESS study highlights Theravance Biopharma's dedication to addressing significant unmet needs in patient care. Ampreloxetine represents hope not just for MSA patients struggling with nOH but also for caregivers and healthcare providers looking for reliable interventions in this challenging area of medicine. As we look to the future, anticipation builds around the upcoming data set that could potentially position ampreloxetine as a transformative agent in this rare disease space.

For more information, please visit Theravance Biopharma.