Ardelyx Shares Additional Data Supporting First-In-Class XPHOZAH® (tenapanor) at the American Society of Nephrology’s Kidney Week
Ardelyx (ARDX) presented additional clinical data for XPHOZAH (tenapanor) at ASN Kidney Week. XPHOZAH, the first phosphate absorption inhibitor, is FDA-approved to reduce serum phosphorus in adults with chronic kidney disease on dialysis as add-on therapy. Two key poster presentations highlighted: (1) A post-hoc analysis showing greater reductions in iFGF23 with better phosphate control, and (2) Data demonstrating XPHOZAH's efficacy when combined with various phosphate binders. The company also hosted an Exhibitor Spotlight on hyperphosphatemia management.
Ardelyx (ARDX) ha presentato dati clinici aggiuntivi per XPHOZAH (tenapanor) durante la ASN Kidney Week. XPHOZAH, il primo inibitore dell'assorbimento del fosfato, è approvato dalla FDA per ridurre il fosforo sierico negli adulti con malattia renale cronica in dialisi come terapia aggiuntiva. Due presentazioni chiave in poster hanno evidenziato: (1) un'analisi post-hoc che mostra riduzioni maggiori in iFGF23 con un migliore controllo del fosfato e (2) dati che dimostrano l'efficacia di XPHOZAH quando combinato con vari leganti del fosfato. Inoltre, l'azienda ha ospitato un Focus su espositori sulla gestione dell'iperfosfatemia.
Ardelyx (ARDX) presentó datos clínicos adicionales para XPHOZAH (tenapanor) en la ASN Kidney Week. XPHOZAH, el primer inhibidor de la absorción de fosfato, está aprobado por la FDA para reducir el fósforo en suero en adultos con enfermedad renal crónica en diálisis como terapia complementaria. Dos presentaciones clave en forma de cartel destacaron: (1) un análisis post-hoc que muestra reducciones mayores en iFGF23 con un mejor control del fosfato, y (2) datos que demuestran la eficacia de XPHOZAH cuando se combina con varios aglutinantes de fosfato. La empresa también organizó un Spotlight de Expositores sobre la gestión de la hiperfosfatemia.
Ardelyx (ARDX)는 ASN Kidney Week에서 XPHOZAH (테나파노르)에 대한 추가 임상 데이터를 발표했습니다. XPHOZAH는 첫 번째 인산염 흡수 억제제로, 만성 신장 질환에 있는 성인의 혈청 인산 수치를 줄이기 위해 FDA 승인을 받았으며, 투석 중 추가 치료로 사용됩니다. 두 가지 핵심 포스터 발표에서는: (1) 더 나은 인산염 조절로 인한 iFGF23의 더 큰 감소를 보여주는 후향적 분석과 (2) 다양한 인산염 결합제와 결합했을 때 XPHOZAH의 효능을 입증하는 데이터를 강조했습니다. 이 회사는 또한 고인산혈증 관리에 대한 전시업체 스포트라이트를 개최했습니다.
Ardelyx (ARDX) a présenté des données cliniques supplémentaires sur XPHOZAH (tenapanor) lors de l'ASN Kidney Week. XPHOZAH, le premier inhibiteur de l'absorption du phosphate, est approuvé par la FDA pour réduire le phosphore sérique chez les adultes atteints de maladie rénale chronique sous dialyse en tant que thérapie add-on. Deux présentations clés de posters ont mis en avant : (1) une analyse post-hoc montrant de plus grandes réductions en iFGF23 avec un meilleur contrôle du phosphate, et (2) des données démontrant l'efficacité de XPHOZAH lorsqu'il est combiné avec divers liants de phosphate. L'entreprise a également organisé un Spotlight sur les exposants concernant la gestion de l'hyperphosphatémie.
Ardelyx (ARDX) hat während der ASN Kidney Week zusätzliche klinische Daten zu XPHOZAH (Tenapanor) präsentiert. XPHOZAH, der erste Inhibitor der Phosphataufnahme, ist von der FDA genehmigt, um den Serumphosphatspiegel bei Erwachsenen mit chronischer Nierenerkrankung unter Dialyse als Zusatztherapie zu senken. Zwei wichtige Posterpräsentationen hoben hervor: (1) Eine Post-hoc-Analyse, die größere Reduktionen in iFGF23 mit besserer Phosphatkontrolle zeigt, und (2) Daten, die die Wirksamkeit von XPHOZAH in Kombination mit verschiedenen Phosphatbindemitteln demonstrieren. Das Unternehmen veranstaltete auch einen Aussteller-Fokus zur Behandlung von Hyperphosphatämie.
- FDA approval secured for XPHOZAH as first-in-class phosphate absorption inhibitor
- Clinical data shows efficacy in reducing serum phosphorus levels
- Demonstrated compatibility and effectiveness when combined with various phosphate binders
- None.
Insights
The presentation of additional clinical data for XPHOZAH® at ASN Kidney Week provides important insights into the drug's efficacy profile. The post-hoc analyses reveal two key findings: reduced iFGF23 levels associated with better phosphate control and consistent efficacy across different phosphate binder combinations.
The iFGF23 reduction is particularly significant as elevated levels are linked to increased cardiovascular mortality in CKD patients. The drug's ability to work effectively with various phosphate binders suggests flexible treatment options for dialysis patients struggling with hyperphosphatemia.
However, while this data supports XPHOZAH's clinical utility, it represents supportive rather than pivotal evidence. The real value driver will be the drug's commercial performance following its recent FDA approval as the first phosphate absorption inhibitor.
WALTHAM, Mass., Oct. 24, 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 data supporting additional positive clinical observations of XPHOZAH® (tenapanor) was presented in a series of poster presentations at the American Society of Nephrology’s (ASN) Kidney Week, currently taking place in San Diego. Ardelyx is also hosting an Exhibitor Spotlight discussing hyperphosphatemia management.
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.
“We are pleased to be able to continue to expand our understanding of the significant impact XPHOZAH can have to help patients with chronic kidney disease on dialysis with elevated phosphorus,” said David Spiegel, MD, senior vice president, nephrology at Ardelyx. “Patients on dialysis and their healthcare providers have long struggled to achieve and maintain serum phosphate levels within guideline-established levels. The addition of XPHOZAH is an important tool in phosphate management and these data demonstrate the benefit that XPHOZAH’s blocking mechanism can offer patients.”
Poster #TH-PO164, entitled “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,” is a post-hoc analysis of the PHREEDOM Phase 3 clinical trial, and assessed whether long-term phosphate (P) control measured using average phosphate area under the curve (P AUC) with tenapanor is associated with lower iFGF23. iFGF23 is elevated in patients with chronic kidney disease and is associated with increased cardiovascular mortality. The analysis observed greater percent reductions from baseline in iFGF23 in P AUC categories representative of better P control than categories representative of worse control.
Poster #TH-PO169, entitled “Tenapanor Reduces Serum Phosphate With Similar Efficacy and Tolerability Profiles When Added to Various Phosphate Binders,” is a post hoc analysis of data from the AMPLIFY Phase 3 clinical trial and OPTIMIZE open-label clinical trial and examined the efficacy and tolerability of tenapanor when added to different phosphate binders (PBs). The analysis found that tenapanor added to PBs provided a clinically meaningful serum P reduction with similar efficacy and tolerability regardless of the type of PB.
Poster presentations are now publicly available and can be accessed on demand here.
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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