Ardelyx to Present Additional Data Supporting First-In-Class XPHOZAH® (tenapanor) for Adults with Chronic Kidney Disease on Dialysis at the American Society of Nephrology’s Kidney Week
Ardelyx (Nasdaq: ARDX) announced that additional data supporting XPHOZAH® (tenapanor) will be presented at the American Society of Nephrology's (ASN) Kidney Week, October 24-27, 2024, in San Diego. XPHOZAH, the first and only phosphate absorption inhibitor (PAI), is FDA-approved to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy.
Two poster presentations will be featured:
- Sustained Phosphate Reduction Assessed by P AUC With Tenapanor Is Associated With Reduced Fibroblast Growth Factor 23 in Patients With CKD and Hyperphosphatemia on Dialysis
- Tenapanor Reduces Serum Phosphate With Similar Efficacy and Tolerability Profiles When Added to Various Phosphate Binders
Additionally, Ardelyx is sponsoring an Exhibitor Spotlight on October 25, 2024, discussing XPHOZAH's mechanism of action, efficacy, and safety data from Phase 3 clinical trials.
Ardelyx (Nasdaq: ARDX) ha annunciato che ulteriori dati a sostegno di XPHOZAH® (tenapanor) saranno presentati alla Kidney Week della American Society of Nephrology (ASN), che si svolgerà dal 24 al 27 ottobre 2024 a San Diego. XPHOZAH, il primo e unico inibitore dell'assorbimento del fosfato (PAI), è approvato dalla FDA per ridurre il fosforo sierico negli adulti con malattia renale cronica (MRC) in dialisi come terapia aggiuntiva.
Saranno presentati due poster:
- La riduzione sostenuta del fosfato valutata tramite P AUC con Tenapanor è associata a una riduzione del fattore di crescita dei fibroblasti 23 nei pazienti con MRC e iperfosfatemia in dialisi
- Il Tenapanor riduce il fosfato sierico con profili di efficacia e tollerabilità simili quando aggiunto a vari leganti del fosfato
Inoltre, Ardelyx sponsorizzerà uno Exhibitor Spotlight il 25 ottobre 2024, discutendo il meccanismo d'azione di XPHOZAH, l'efficacia e i dati di sicurezza dei trial clinici di Fase 3.
Ardelyx (Nasdaq: ARDX) anunció que se presentarán datos adicionales que respaldan a XPHOZAH® (tenapanor) en la Semana del Riñón de la Sociedad Americana de Nefrología (ASN), que se llevará a cabo del 24 al 27 de octubre de 2024 en San Diego. XPHOZAH, el primer y único inhibidor de la absorción de fosfato (PAI), está aprobado por la FDA para reducir el fósforo sérico en adultos con enfermedad renal crónica (ERC) en diálisis como terapia complementaria.
Se presentarán dos pósters:
- La reducción sostenida de fosfato evaluada por P AUC con Tenapanor está asociada con la reducción del factor de crecimiento de fibroblastos 23 en pacientes con ERC e hiperfosfatemia en diálisis
- Tenapanor reduce el fosfato sérico con perfiles de eficacia y tolerabilidad similares cuando se añade a varios agentes quelantes de fosfato
Además, Ardelyx patrocinará un Exhibitor Spotlight el 25 de octubre de 2024, discutiendo el mecanismo de acción de XPHOZAH, la eficacia y los datos de seguridad de los ensayos clínicos de Fase 3.
Ardelyx (Nasdaq: ARDX)는 XPHOZAH® (tenapanor)에 대한 추가 데이터가 2024년 10월 24일부터 27일까지 샌디에이고에서 열리는 미국신장학회(ASN) 신장 주간에서 발표될 것이라고 발표했습니다. XPHOZAH는 최초이자 유일한 인산염 흡수 억제제(PAI)로서, FDA 승인을 받았습니다며, 투석 중인 만성 신장 질환(CKD) 성인의 혈청 인을 줄이기 위한 추가 요법으로 승인되었습니다.
두 개의 포스터 발표가 포함될 예정입니다:
- Tenapanor로 평가된 P AUC에 따른 지속적인 인산염 감소는 투석 중인 CKD 및 고인산혈증 환자에서 섬유아세포 성장 인자 23의 감소와 관련이 있습니다.
- Tenapanor는 다양한 인산염 결합제와 함께 추가될 때 유사한 효능 및 내약성 프로필로 혈청 인산염을 감소시킵니다.
또한 Ardelyx는 2024년 10월 25일에 XPHOZAH의 작용 메커니즘, 효능 및 3상 임상 시험의 안전성 데이터를 논의하는 Exhibitor Spotlight를 후원합니다.
Ardelyx (Nasdaq: ARDX) a annoncé que des données supplémentaires soutenant XPHOZAH® (tenapanor) seront présentées lors de la Kidney Week de l'American Society of Nephrology (ASN), qui se tiendra du 24 au 27 octobre 2024 à San Diego. XPHOZAH, le premier et unique inhibiteur de l'absorption du phosphate (PAI), est apprové par la FDA pour réduire le phosphore sérique chez les adultes atteints d'une maladie rénale chronique (MRC) en dialyse comme thérapie additionnelle.
Deux présentations sous forme de poster seront mises en avant :
- La réduction soutenue du phosphate évaluée par P AUC avec Tenapanor est associée à une réduction du fibroblast growth factor 23 chez les patients atteints de MRC et d'hyperphosphatémie en dialyse.
- Le Tenapanor réduit le phosphate sérique avec des profils d'efficacité et de tolérabilité similaires lorsqu'il est ajouté à divers chélateurs de phosphate.
De plus, Ardelyx parrainera un Exhibitor Spotlight le 25 octobre 2024, discutant du mécanisme d'action de XPHOZAH, de son efficacité et des données de sécurité issues des essais cliniques de phase 3.
Ardelyx (Nasdaq: ARDX) gab bekannt, dass zusätzliche Daten zu XPHOZAH® (tenapanor) auf der Kidney Week der American Society of Nephrology (ASN) vom 24. bis 27. Oktober 2024 in San Diego präsentiert werden. XPHOZAH, der erste und einzige Inhibitor der Phosphatabsorption (PAI), ist von der FDA genehmigt, um den Serumphosphor bei Erwachsenen mit chronischer Nierenerkrankung (CKD), die sich in Dialyse befinden, als Zusatztherapie zu senken.
Es werden zwei Posterpräsentationen vorgestellt:
- Die anhaltende Phosphatreduktion, die durch P AUC mit Tenapanor bewertet wurde, ist assoziiert mit einer reduzierten Fibroblastwachstumsfaktor 23 bei Patienten mit CKD und Hyperphosphatämie in Dialyse.
- Tenapanor reduziert Serumphosphat mit ähnlichen Wirksamkeits- und Verträglichkeitsprofilen, wenn es verschiedenen Phosphatbinder hinzugefügt wird.
Darüber hinaus sponsert Ardelyx am 25. Oktober 2024 ein Exhibitor Spotlight, das den Wirkmechanismus von XPHOZAH, die Wirksamkeit und Sicherheitsdaten aus den Phase-3-Studien diskutiert.
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WALTHAM, Mass., Oct. 15, 2024 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that additional data supporting XPHOZAH® (tenapanor) will be presented at the American Society of Nephrology’s (ASN) Kidney Week, to be held October 24-27, 2024, in San Diego.
XPHOZAH, the first and only phosphate absorption inhibitor (PAI), is approved by the U.S. Food and Drug Administration to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. XPHOZAH offers a different mechanism of action that blocks phosphate absorption at the primary pathway and is administered as a single tablet taken twice daily.
Information regarding ASN's Kidney Week, including copies of presentation abstracts, can be found here.
Title: Sustained Phosphate Reduction Assessed by P AUC With Tenapanor Is Associated With Reduced Fibroblast Growth Factor 23 in Patients With Chronic Kidney Disease and Hyperphosphatemia on Dialysis
Authors: Kevin J. Martin, Simon Higgins, Yang Yang, David P. Rosenbaum, David M. Spiegel
Poster Number: TH-PO164
Date/Time: October 24, 2024, from 10:00 AM – 12:00 PM PDT (UTC –7)
Title: Tenapanor Reduces Serum Phosphate With Similar Efficacy and Tolerability Profiles When Added to Various Phosphate Binders
Authors: Stuart M. Sprague, David P. Tietjen, Jesslyn Roesch, Yang Yang, Suling Zhao, Susan A. Edelstein, David P. Rosenbaum, David M. Spiegel
Poster Number: TH-PO169
Date/Time: October 24, 2024, from 10:00 AM – 12:00 PM PDT (UTC –7)
In addition to the poster presentations during ASN Kidney Week, Ardelyx is sponsoring an Exhibitor Spotlight titled: “A Different Perspective on Hyperphosphatemia Management: Evaluating Current Strategies,” on October 25, 2024, from 11:00 – 11:45 AM PDT, where Steven Fishbane, MD, will discuss first-in-class PAI, XPHOZAH. The presentation will review the XPHOZAH mechanism of action, efficacy and safety data from the Phase 3 clinical trial program and will include a discussion about the clinical application of XPHOZAH as add-on therapy for the many dialysis patients on a phosphate binder with serum phosphorus levels above guideline-established targets.
About XPHOZAH® (tenapanor)
XPHOZAH, discovered and developed by Ardelyx, is a first-in-class, phosphate absorption inhibitor with a differentiated mechanism of action that acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), thereby reducing phosphate absorption through the paracellular pathway, the primary pathway of phosphate absorption. XPHOZAH is a single tablet, taken twice daily. Diarrhea was the most common side effect experienced by patients taking XPHOZAH in clinical trials. Please see additional full Prescribing Information.
About Hyperphosphatemia
Hyperphosphatemia is a serious condition, defined as elevated levels of phosphate in the blood, which affects the vast majority of the 550,000 patients in the United States with chronic kidney disease (CKD) on maintenance dialysis. The kidneys are responsible for eliminating excess phosphate and as kidney function declines, phosphate is not adequately eliminated from the body. As a result, hyperphosphatemia is a nearly universal condition among people with CKD on maintenance dialysis, with internationally recognized KDIGO treatment guidelines that recommend lowering elevated phosphate levels toward the normal range (2.5-4.5mg/dL).
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
XPHOZAH is contraindicated in:
- Pediatric patients under 6 years of age
- Patients with known or suspected mechanical gastrointestinal obstruction
WARNINGS AND PRECAUTIONS
Diarrhea
Patients may experience severe diarrhea. Treatment with XPHOZAH should be discontinued in patients who develop severe diarrhea.
MOST COMMON ADVERSE REACTIONS
Diarrhea, which occurred in 43
INDICATION
XPHOZAH (tenapanor), 30 mg BID, is indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.
For additional safety information, please see full Prescribing Information.
About Ardelyx
Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been submitted in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. For more information, please visit https://ardelyx.com/ and connect with us on X (formerly known as Twitter), LinkedIn and Facebook.
Investor and Media Contacts:
Caitlin Lowie
clowie@ardelyx.com
FAQ
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