Theravance to Present Analyses of Ampreloxetine and Neurogenic Orthostatic Hypotension at the 2025 International MSA Congress
Theravance Biopharma (NASDAQ: TBPH) has announced upcoming presentations of analyses from their ampreloxetine Phase 3 program at the International MSA Congress in Boston, May 9-11, 2025. The analyses focus on Studies 169 and 170, supporting ampreloxetine's potential in treating neurogenic orthostatic hypotension (nOH) in multiple system atrophy (MSA) patients.
The presentations include a plenary oral session and poster sessions featuring:
- A pre-specified subgroup analysis of a phase 3 trial by Norcliffe-Kaufmann L, et al.
- Analysis of symptomatic nOH impact on symptom burden by Iodice V, et al.
These analyses support the ongoing CYPRESS registrational study (NCT05696717) in patients with nOH and MSA, demonstrating the company's commitment to understanding ampreloxetine's selective mechanism of action.
Theravance Biopharma (NASDAQ: TBPH) ha annunciato le prossime presentazioni delle analisi del programma di fase 3 di ampreloxetine al International MSA Congress che si terrà a Boston dal 9 all'11 maggio 2025. Le analisi riguardano gli Studi 169 e 170 e supportano il potenziale di ampreloxetine nel trattamento dell'ipotensione ortostatica neurogena (nOH) nei pazienti con atrofia multisistemica (MSA).
Le presentazioni includono una sessione plenaria orale e sessioni poster con:
- Un'analisi di sottogruppo predefinita di uno studio di fase 3 condotto da Norcliffe-Kaufmann L, et al.
- Un'analisi dell'impatto sintomatico dell'nOH sul carico dei sintomi a cura di Iodice V, et al.
Queste analisi supportano lo studio di registrazione CYPRESS (NCT05696717) in corso su pazienti con nOH e MSA, dimostrando l'impegno dell'azienda nel comprendere il meccanismo d'azione selettivo di ampreloxetine.
Theravance Biopharma (NASDAQ: TBPH) ha anunciado próximas presentaciones de análisis de su programa de fase 3 de ampreloxetina en el International MSA Congress en Boston, del 9 al 11 de mayo de 2025. Los análisis se centran en los Estudios 169 y 170, que respaldan el potencial de ampreloxetina para tratar la hipotensión ortostática neurogénica (nOH) en pacientes con atrofia multisistémica (MSA).
Las presentaciones incluyen una sesión plenaria oral y sesiones de póster que presentan:
- Un análisis de subgrupo preespecificado de un ensayo de fase 3 realizado por Norcliffe-Kaufmann L, et al.
- Análisis del impacto sintomático de la nOH sobre la carga de síntomas por Iodice V, et al.
Estos análisis apoyan el estudio de registro CYPRESS (NCT05696717) en pacientes con nOH y MSA, demostrando el compromiso de la compañía para comprender el mecanismo de acción selectivo de ampreloxetina.
Theravance Biopharma (NASDAQ: TBPH)는 2025년 5월 9일부터 11일까지 보스턴에서 열리는 International MSA Congress에서 ampreloxetine 3상 프로그램 분석 결과를 발표할 예정입니다. 분석은 연구 169와 170에 중점을 두며, 다계통 위축증(MSA) 환자의 신경성 기립성 저혈압(nOH) 치료에 대한 ampreloxetine의 잠재력을 뒷받침합니다.
발표는 구두 전체 세션과 포스터 세션으로 구성되며 다음을 포함합니다:
- Norcliffe-Kaufmann L 등 연구진의 3상 시험 사전 지정 하위 그룹 분석
- Iodice V 등 연구진의 증상 부담에 대한 nOH 증상 영향 분석
이 분석들은 nOH 및 MSA 환자를 대상으로 하는 진행 중인 CYPRESS 등록 연구(NCT05696717)를 지원하며, ampreloxetine의 선택적 작용 기전에 대한 회사의 의지를 보여줍니다.
Theravance Biopharma (NASDAQ : TBPH) a annoncé les prochaines présentations des analyses issues de leur programme de phase 3 sur l'ampreloxetine lors du International MSA Congress à Boston, du 9 au 11 mai 2025. Ces analyses portent sur les études 169 et 170, soutenant le potentiel de l'ampreloxetine dans le traitement de l'hypotension orthostatique neurogène (nOH) chez les patients atteints d'atrophie multisystémique (MSA).
Les présentations incluent une session orale plénière et des sessions de posters présentant :
- Une analyse de sous-groupe pré-spécifiée d'un essai de phase 3 menée par Norcliffe-Kaufmann L et al.
- Une analyse de l'impact symptomatique de la nOH sur la charge des symptômes par Iodice V et al.
Ces analyses soutiennent l'étude d'enregistrement en cours CYPRESS (NCT05696717) chez des patients atteints de nOH et de MSA, démontrant l'engagement de la société à comprendre le mécanisme d'action sélectif de l'ampreloxetine.
Theravance Biopharma (NASDAQ: TBPH) hat die bevorstehenden Präsentationen von Analysen ihres Ampreloxetin-Phase-3-Programms auf dem International MSA Congress in Boston vom 9. bis 11. Mai 2025 angekündigt. Die Analysen konzentrieren sich auf die Studien 169 und 170 und unterstützen das Potenzial von Ampreloxetin zur Behandlung der neurogenen orthostatischen Hypotonie (nOH) bei Patienten mit multipler Systematrophie (MSA).
Die Präsentationen umfassen eine Plenarvortragssitzung und Postersitzungen mit:
- einer vordefinierten Subgruppenanalyse einer Phase-3-Studie von Norcliffe-Kaufmann L et al.
- einer Analyse der symptomatischen Auswirkungen von nOH auf die Symptombelastung von Iodice V et al.
Diese Analysen unterstützen die laufende CYPRESS-Registerstudie (NCT05696717) bei Patienten mit nOH und MSA und zeigen das Engagement des Unternehmens, den selektiven Wirkmechanismus von Ampreloxetin besser zu verstehen.
- None.
- None.
Analyses will be presented in a plenary oral session Friday, May 9, and poster sessions Friday, May 9, 2025, and Saturday, May 10, 2025:
Ampreloxetine in MSA: A pre-specified subgroup analysis of a phase 3, double-blind, placebo-controlled, randomized withdrawal trial
- Norcliffe-Kaufmann L, et al. Oral Presentation May 9, 2025 - 9:40 AM EDT
- Norcliffe-Kaufmann L, et al. Poster #78 May 10, 2025 - 12:00 PM EDT
Impact of symptomatic neurogenic orthostatic hypotension on symptom burden and daily functioning in patients with alpha synucleinopathies
- Iodice V, et al. Poster #29 May 9, 2025 - 11:45 AM EDT
More information on the session and abstracts may be found here.
About ampreloxetine
Ampreloxetine, an investigational, once-daily norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA). The unique benefits of ampreloxetine treatment reported in MSA patients from Study 0170 included an increase in norepinephrine levels, a favorable impact on blood pressure, clinically meaningful and durable symptom improvement, and no signal for worsening of supine hypertension. In the US, the Company has been granted an Orphan Drug Designation for ampreloxetine for the treatment of symptomatic nOH in patients with MSA and, if results from the ongoing Phase 3 CYPRESS study are supportive, plans to file an NDA for full approval in this indication.
About CYPRESS (Study 0197), a Phase 3 Study
Study 0197 (NCT05696717) is currently enrolling. This is a registrational Phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment; the primary endpoint of the study is change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score. The Study includes four periods: screening, open label (12-week period, participants will receive a single daily 10 mg dose of ampreloxetine), randomized withdrawal (eight-week period, double-blind, placebo-controlled, participants will receive a single daily 10 mg dose of placebo or ampreloxetine), and a long-term treatment extension. Secondary outcome measures include change from baseline in Orthostatic Hypotension Daily Activity Scale (OHDAS) item 1 (activities that require standing for a short time) and item 3 (activities that require walking for a short time).
About the ampreloxetine Phase 3 Program (Study 169 and Study 170)
Study 0169 (NCT03750552) was a Phase 3, 4-week, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of ampreloxetine compared to placebo in patients with symptomatic nOH (n=195). Patients from Study 0169 were eligible to enter into Study 0170 (NCT03829657), a Phase 3, multi-center, 22-week study comprising a 16-week open-label period and a 6-week double-blind, placebo-controlled, randomized withdrawal period to evaluate the sustained benefit in efficacy and safety of ampreloxetine in patients with symptomatic nOH. The primary endpoint for Study 0170 of treatment failure at week 6 was defined as a worsening of both Orthostatic Hypotension Symptom Assessment Scale (OHSA) question #1 and Patient Global Impression of Severity (PGI-S) scores by 1.0 point. After Study 0169 did not meet its primary endpoint, the Company took actions to close out the ongoing clinical program including Study 0170. The study was more than
About Multiple System Atrophy (MSA) and Symptomatic Neurogenic Orthostatic Hypotension (nOH)
MSA is a progressive brain disorder that affects movement and balance and disrupts the function of the autonomic nervous system. The autonomic nervous system controls body functions that are mostly involuntary. One of the most frequent autonomic symptoms associated with MSA is a sudden drop in blood pressure upon standing (nOH).1 There are approximately 50,000 MSA patients in the US2 and 70
Neurogenic orthostatic hypotension (nOH) is a rare disorder defined as a fall in systolic blood pressure of ⩾20 mm Hg or diastolic blood pressure of ⩾10 mm Hg, within 3 minutes of standing. Severely affected patients are unable to stand for more than a few seconds because of their decrease in blood pressure, leading to cerebral hypoperfusion and syncope. A debilitating condition, nOH results in a range of symptoms including dizziness, lightheadedness, fainting, fatigue, blurry vision, weakness, trouble concentrating, and head and neck pain.
About Theravance Biopharma
Theravance Biopharma, Inc.'s focus is to deliver Medicines that Make a Difference® in people's lives. In pursuit of its purpose, Theravance Biopharma leverages decades of expertise, which has led to the development of FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Ampreloxetine, its late-stage investigational once-daily norepinephrine reuptake inhibitor in development for symptomatic neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA), has the potential to be a first in class therapy effective in treating a constellation of cardinal symptoms in MSA patients. The Company is committed to creating/driving shareholder value.
For more information, please visit www.theravance.com.
THERAVANCE BIOPHARMA®, THERAVANCE®, and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies (in the
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Forward-Looking Statements
This press release will contain certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations, and future events. Theravance Biopharma intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to: the Company's goals, designs, strategies, plans and objectives, the Company's regulatory strategies and timing of clinical studies (including the data therefrom), the Company's goals, designs, strategies, plans, potential, and objectives, the Company's regulatory strategies and timing of clinical studies, potential or possible safety, efficacy or differentiation of our investigational therapy, and expectations around the use of OHSA scores as endpoints for clinical trials. These statements are based on the current estimates and assumptions of the management of Theravance Biopharma as of the date of this press release and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance Biopharma to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: delays or difficulties in commencing, enrolling or completing clinical studies, the potential that results from clinical or non-clinical studies indicate the Company's product candidates or product are unsafe, ineffective or not differentiated, risks of decisions from regulatory authorities that are unfavorable to the Company, dependence on third parties to conduct clinical studies, delays or failure to achieve and maintain regulatory approvals for product candidates, risks of collaborating with or relying on third parties to discover, develop, manufacture and commercialize products, ability to retain key personnel, the ability of the Company to protect and to enforce its intellectual property rights, volatility and fluctuations in the trading price and volume of the Company's shares, and general economic and market conditions. Other risks affecting the Company are in the Company's Form 10-K filed with the SEC on March 7, 2025, and other periodic reports filed with the SEC. In addition to the risks described above and in Theravance Biopharma's filings with the SEC, other unknown or unpredictable factors also could affect Theravance Biopharma's results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance Biopharma assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.
1 https://medlineplus.gov/genetics/condition/multiple-system-atrophy/
2 UCSD Neurological Institute (25K-75K, with ~10K new cases per year); NIH National Institute of Neurological Disorders and Stroke (15K-50K).
3 Delveinsight MSA Market Forecast (2023); Symptoms associated with orthostatic hypotension in pure autonomic failure and multiple systems atrophy, CJ Mathias (1999).
Contact:
investor.relations@theravance.com
650-808-4045
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