Theravance Biopharma to Present New Ampreloxetine Analyses in Neurogenic Orthostatic Hypotension (nOH) at the 77th Annual Meeting of the American Academy of Neurology
Theravance Biopharma (NASDAQ: TBPH) has announced new analyses of their Phase 3 ampreloxetine program for Neurogenic Orthostatic Hypotension (nOH) to be presented at the 77th Annual Meeting of the American Academy of Neurology (AAN) in San Diego from April 5-9, 2025.
The presentations, scheduled for April 7, 2025, will showcase findings from Studies 169 and 170, which led to the ongoing Phase 3 confirmatory CYPRESS Study 197 focusing on nOH in multiple system atrophy patients. Two key presentations will be delivered:
- NET-Inhibition with Ampreloxetine, Blood Pressure, and Catecholamines in nOH Patients
- The Impact of Ampreloxetine on Supine Hypertension: An Ambulatory Blood Pressure Monitoring Study
Theravance Biopharma (NASDAQ: TBPH) ha annunciato nuove analisi del loro programma di fase 3 ampreloxetina per l'ipotensione ortostatica neurogena (nOH), che saranno presentate al 77° Congresso Annuale dell'Accademia Americana di Neurologia (AAN) a San Diego dal 5 al 9 aprile 2025.
Le presentazioni, programmate per il 7 aprile 2025, mostreranno i risultati degli Studi 169 e 170, che hanno portato all'attuale Studio di Conferma CYPRESS 197 in fase 3, focalizzato sull'nOH nei pazienti con atrofia multisistemica. Due presentazioni chiave saranno effettuate:
- Inibizione della NET con Ampreloxetina, Pressione Sanguigna e Catecolamine nei Pazienti con nOH
- L'Impatto dell'Ampreloxetina sull'Ipertensione in Decubito: Uno Studio di Monitoraggio della Pressione Sanguigna Ambulatoriale
Theravance Biopharma (NASDAQ: TBPH) ha anunciado nuevos análisis de su programa de fase 3 con ampreloxetina para la Hipotensión Ortostática Neurogénica (nOH), que se presentarán en el 77° Congreso Anual de la Academia Americana de Neurología (AAN) en San Diego del 5 al 9 de abril de 2025.
Las presentaciones, programadas para el 7 de abril de 2025, mostrarán los hallazgos de los Estudios 169 y 170, que llevaron al actual Estudio de Confirmación CYPRESS 197 en fase 3, centrado en nOH en pacientes con atrofia multisistémica. Se realizarán dos presentaciones clave:
- Inhibición de NET con Ampreloxetina, Presión Arterial y Catecolaminas en Pacientes con nOH
- El Impacto de la Ampreloxetina en la Hipertensión en Decúbito: Un Estudio de Monitoreo Ambulatorio de la Presión Arterial
Theravance Biopharma (NASDAQ: TBPH)는 신경성 기립성 저혈압(nOH)에 대한 3상 ampreloxetine 프로그램의 새로운 분석을 발표한다고 발표했습니다. 이 내용은 2025년 4월 5일부터 9일까지 샌디에이고에서 열리는 미국 신경학회(AAN) 제77회 연례 회의에서 발표될 예정입니다.
2025년 4월 7일로 예정된 발표에서는 nOH가 있는 다계통 위축 환자에 초점을 맞춘 현재 진행 중인 3상 확인 연구인 CYPRESS 연구 197의 결과를 포함하여 연구 169 및 170의 결과를 보여줄 것입니다. 두 가지 주요 발표가 있을 예정입니다:
- nOH 환자에서 Ampreloxetine에 의한 NET 억제, 혈압 및 카테콜라민
- 앰프레록세틴이 누워 있을 때 고혈압에 미치는 영향: 외래 혈압 모니터링 연구
Theravance Biopharma (NASDAQ: TBPH) a annoncé de nouvelles analyses de son programme de phase 3 avec l'ampréloxétine pour l'hypotension orthostatique neurogène (nOH), qui seront présentées lors de la 77e Réunion Annuelle de l'Académie Américaine de Neurologie (AAN) à San Diego du 5 au 9 avril 2025.
Les présentations, prévues pour le 7 avril 2025, mettront en avant les résultats des Études 169 et 170, qui ont conduit à l'étude de confirmation CYPRESS 197 en phase 3, axée sur la nOH chez les patients atteints d'atrophie multisystémique. Deux présentations clés seront faites :
- Inhibition de la NET avec l'Ampréloxétine, Pression Artérielle et Catécholamines chez les Patients atteints de nOH
- L'Impact de l'Ampréloxétine sur l'Hypertension en Position Couchée : Une Étude de Surveillance Ambulatoire de la Pression Artérielle
Theravance Biopharma (NASDAQ: TBPH) hat neue Analysen ihres Phase-3-Programms mit Ampreloxetin für neurogene orthostatische Hypotonie (nOH) angekündigt, die auf dem 77. Jahreskongress der American Academy of Neurology (AAN) in San Diego vom 5. bis 9. April 2025 präsentiert werden.
Die Präsentationen, die für den 7. April 2025 geplant sind, werden Ergebnisse der Studien 169 und 170 zeigen, die zur laufenden Phase-3-Bestätigungsstudie CYPRESS 197 geführt haben, die sich auf nOH bei Patienten mit multisystemischer Atrophie konzentriert. Es werden zwei wichtige Präsentationen gehalten:
- NET-Inhibition mit Ampreloxetin, Blutdruck und Katecholaminen bei nOH-Patienten
- Die Auswirkungen von Ampreloxetin auf die supine Hypertonie: Eine ambulante Blutdrucküberwachungsstudie
- None.
- None.
Analyses will be presented consecutively in a platform session on Monday, April 7, 2025, starting at 11:15 AM Pacific Daylight Time (2:15 PM EDT / 6:15 PM GMT):
- Iodice V, et al. Program Number S9.001
NET-Inhibition with Ampreloxetine, Blood Pressure, and Catecholamines in Patients with Neurogenic Orthostatic Hypotension
- Norcliffe-Kaufmann L, et al. Program Number S9.002
The Impact of Ampreloxetine on Supine Hypertension: An Ambulatory Blood Pressure Monitoring Study
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 0170 (NCT03829657) was a 22-week Phase 3 study comprised of a 16-week open-label period and a 6-week double-blind, placebo-controlled, randomized withdrawal period. This study followed study 0169, a Phase 3, four week randomized, double-blind, placebo-controlled, parallel-group study 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 U.S. and certain other countries).
YUPELRI® is a registered trademark of Mylan Specialty L.P., a Viatris company. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.
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.
Contact:
investor.relations@theravance.com
650-808-4045
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).
View original content to download multimedia:https://www.prnewswire.com/news-releases/theravance-biopharma-to-present-new-ampreloxetine-analyses-in-neurogenic-orthostatic-hypotension-noh-at-the-77th-annual-meeting-of-the-american-academy-of-neurology-302412933.html
SOURCE Theravance Biopharma, Inc.