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Theravance Biopharma Showcases Ampreloxetine Data at International Symposium

Theravance Biopharma, Inc. (NASDAQ: TBPH) is gearing up for its participation at the 36th International Symposium on The Autonomic Nervous System, hosted by the American Autonomic Society (AAS) from November 5-8, 2025, in Clearwater Beach, Florida. This year's symposium promises to spotlight some groundbreaking developments in the treatment of neurogenic orthostatic hypotension (nOH), particularly focusing on the company's investigational drug, ampreloxetine.

The company will present a total of four studies at the event, which includes one significant platform presentation and three poster presentations that delve into its clinical development program for ampreloxetine. This compound is being evaluated for its potential as a first-in-class norepinephrine reuptake inhibitor aimed at addressing nOH symptoms that arise from multiple system atrophy (MSA).

Lucy Norcliffe-Kaufmann, Ph.D., the Executive Director of Clinical Science at Theravance Biopharma, expressed enthusiasm about the company's active role at the symposium. She stated, "Our platform presentation will showcase results from the REDWOOD trial, where we noted significant symptomatic benefits in patients treated with ampreloxetine, particularly in daily living activities for those with MSA."

Presentation Highlights

In terms of format, the key platform presentation titled "Precision therapy with ampreloxetine for neurogenic orthostatic hypotension in multiple system atrophy" will take place on November 8, 2025, at 8:30 AM ET. Dr. Norcliffe-Kaufmann will lead this presentation, emphasizing the drug's unique approach to managing the debilitating symptoms associated with nOH.

On November 6, three enlightening posters will be shared during Poster Session II, scheduled from 7:00 PM to 8:30 PM ET. The posters will cover the following topics:
1. The impact of ampreloxetine on supine hypertension: An ambulatory blood pressure monitoring study. (Presenter: Dr. Lucy Norcliffe-Kaufmann, Poster number 9)
2. Retention strategies in rare disease clinical trials: A case study of symptomatic treatment for multiple system atrophy. (Presenter: Molly Szpyhulsky, MBA, RN, Poster number 15)
3. Enrollment strategies in a phase III trial for MSA-related nOH: Insights from global investigators. (Presenter: Molly Szpyhulsky, Poster number 10)

Understanding Ampreloxetine

Ampreloxetine is an investigational once-daily, selective norepinephrine reuptake inhibitor targeting symptomatic nOH in patients suffering from MSA. Initial studies, including the recently conducted Study 0170, reported promising enhancement in norepinephrine levels and notable improvements in patients' blood pressure regulation. The results have demonstrated not only significant symptom alleviation but also safety, as no worsening of supine hypertension was observed among participants.

Significance of the CYPRESS Study

At the upcoming symposium, Theravance will also touch upon findings from the ongoing Phase 3 CYPRESS study (NCT05696717). This study aims to further investigate the effectiveness and durability of ampreloxetine in MSA patients experiencing symptomatic nOH after a 20-week treatment period. The primary endpoint focuses on changes in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score. Secondary outcomes will involve evaluating improvements in daily activities that require standing and walking.

The Challenge of MSA

Multiple System Atrophy is a progressive neurological ailment that impacts both movement and involuntary bodily functions due to autonomic dysfunction. Notably, nOH is a serious complication, manifesting as a significant drop in blood pressure upon standing, leading to symptoms such as dizziness, fatigue, and even syncope.

In the U.S. alone, it is estimated that over 50,000 individuals suffer from MSA, with a staggering 70-90% experiencing symptomatic nOH. While some therapies exist, many patients find limited relief, emphasizing the urgency for more effective treatment solutions.

Conclusion

Theravance Biopharma is not only keen on sharing its promising data at the International Symposium but also committed to advancing care in neurodegenerative disorders through innovative therapies such as ampreloxetine. As the results of their comprehensive studies unfold, anticipation builds in the medical community for a viable breakthrough that could potentially enhance the quality of life for MSA patients grappling with debilitating nOH symptoms.