Ardelyx Announces Publication of Two Plain Language Summaries from XPHOZAH® (tenapanor) Clinical Trials in Current Medical Research and Opinion
Ardelyx, Inc. (Nasdaq: ARDX) has published plain language summaries of two clinical trials for XPHOZAH® (tenapanor) in Current Medical Research and Opinion. These summaries, from the NORMALIZE and OPTIMIZE studies, aim to help patients with chronic kidney disease on dialysis understand the safety and efficacy data of XPHOZAH. The FDA-approved drug is the first and only phosphate absorption inhibitor designed to reduce serum phosphorus in adult CKD patients on dialysis. It's used as an add-on therapy for patients with inadequate response to or intolerance of phosphate binders. XPHOZAH's unique mechanism blocks phosphate absorption at the primary pathway and is administered as a single tablet twice daily. The summaries provide accessible information about XPHOZAH's potential impact on lowering serum phosphorus levels, helping patients and caregivers make informed decisions about treatment options.
Ardelyx, Inc. (Nasdaq: ARDX) ha pubblicato riassunti in linguaggio semplice di due studi clinici per XPHOZAH® (tenapanor) in Current Medical Research and Opinion. Questi riassunti, provenienti dagli studi NORMALIZE e OPTIMIZE, mirano ad aiutare i pazienti con malattia renale cronica in dialisi a comprendere i dati di sicurezza ed efficacia di XPHOZAH. Il farmaco approvato dalla FDA è il primo e unico inibitore dell'assorbimento del fosfato progettato per ridurre il fosforo sierico nei pazienti adulti con CKD in dialisi. Viene utilizzato come terapia aggiuntiva per i pazienti con risposta inadeguata o intolleranza ai leganti del fosfato. Il meccanismo unico di XPHOZAH blocca l'assorbimento del fosfato nel principale percorso e viene somministrato come una singola compressa due volte al giorno. I riassunti forniscono informazioni accessibili sull'impatto potenziale di XPHOZAH sulla riduzione dei livelli di fosforo sierico, aiutando pazienti e caregiver a prendere decisioni informate sulle opzioni di trattamento.
Ardelyx, Inc. (Nasdaq: ARDX) ha publicado resúmenes en un lenguaje sencillo de dos ensayos clínicos para XPHOZAH® (tenapanor) en Current Medical Research and Opinion. Estos resúmenes, provenientes de los estudios NORMALIZE y OPTIMIZE, tienen como objetivo ayudar a los pacientes con enfermedad renal crónica en diálisis a entender los datos de seguridad y eficacia de XPHOZAH. El medicamento aprobado por la FDA es el primer y único inhibidor de la absorción de fosfato diseñado para reducir el fósforo sérico en pacientes adultos con CKD en diálisis. Se utiliza como terapia complementaria para pacientes con respuesta inadecuada o intolerancia a los quelantes de fosfato. El mecanismo único de XPHOZAH bloquea la absorción de fosfato en la vía principal y se administra como una tableta única dos veces al día. Los resúmenes proporcionan información accesible sobre el impacto potencial de XPHOZAH en la reducción de los niveles de fósforo sérico, ayudando a pacientes y cuidadores a tomar decisiones informadas sobre las opciones de tratamiento.
Ardelyx, Inc. (Nasdaq: ARDX)는 Current Medical Research and Opinion에 대해 XPHOZAH® (tenapanor)의 두 임상 시험에 대한 간단한 언어 요약을 발표했습니다. 이 요약은 NORMALIZE 및 OPTIMIZE 연구에서 나온 것으로, 투석 중인 만성 신장병 환자가 XPHOZAH의 안전성 및 효능 데이터를 이해하는 데 도움을 주기 위한 것입니다. FDA 승인 약물인 XPHOZAH는 첫 번째이자 유일한 인산염 흡수 억제제로, 투석 중인 성인 CKD 환자의 혈청 인산을 줄이도록 설계되었습니다. 인산염 결합제에 대한 반응이 불충분하거나 내성이 없는 환자를 위한 추가 요법으로 사용됩니다. XPHOZAH의 독특한 메커니즘은 주요 경로에서 인산염 흡수를 차단하며, 하루 두 번 단일 정제로 투여됩니다. 이 요약은 XPHOZAH가 혈청 인산 수치를 낮추는 잠재적 영향에 대한 접근 가능한 정보를 제공하여 환자와 간병인이 치료 옵션에 대해 정보에 입각한 결정을 내리는 데 도움을 줍니다.
Ardelyx, Inc. (Nasdaq: ARDX) a publié des résumés en langage clair de deux essais cliniques pour XPHOZAH® (tenapanor) dans Current Medical Research and Opinion. Ces résumés, issus des études NORMALIZE et OPTIMIZE, visent à aider les patients atteints d'insuffisance rénale chronique sous dialyse à comprendre les données de sécurité et d'efficacité de XPHOZAH. Ce médicament approuvé par la FDA est le premier et seul inhibiteur de l'absorption du phosphate conçu pour réduire le phosphore sérique chez les patients adultes atteints de CKD sous dialyse. Il est utilisé comme thérapie complémentaire pour les patients ayant une réponse inadéquate ou une intolérance aux liants de phosphate. Le mécanisme unique de XPHOZAH bloque l'absorption du phosphate par la voie principale et est administré sous forme de comprimé unique deux fois par jour. Les résumés fournissent des informations accessibles sur l'impact potentiel de XPHOZAH dans la réduction des niveaux de phosphore sérique, aidant ainsi les patients et les aidants à prendre des décisions éclairées concernant les options de traitement.
Ardelyx, Inc. (Nasdaq: ARDX) hat in Current Medical Research and Opinion leicht verständliche Zusammenfassungen von zwei klinischen Studien zu XPHOZAH® (tenapanor) veröffentlicht. Diese Zusammenfassungen stammen aus den NORMALIZE und OPTIMIZE Studien und sollen Patienten mit chronischer Nierenerkrankung in Dialyse dabei helfen, die Sicherheits- und Wirksamkeitsdaten von XPHOZAH zu verstehen. Das von der FDA zugelassene Medikament ist der erste und einzige Inhibitor der Phosphatabsorption, der entwickelt wurde, um den Serumphosphatspiegel bei erwachsenen CKD-Patienten in Dialyse zu senken. Es wird als Zusatztherapie für Patienten verwendet, die unzureichend auf oder intolerant gegenüber Phosphatbindemitteln ansprechen. Der einzigartige Mechanismus von XPHOZAH blockiert die Phosphatabsorption im Hauptweg und wird als einzelne Tablette zweimal täglich verabreicht. Die Zusammenfassungen bieten zugängliche Informationen über das potenzielle Wirken von XPHOZAH zur Senkung der Serumphosphatwerte und helfen Patienten und Betreuern, informierte Entscheidungen über Behandlungsoptionen zu treffen.
- FDA approval of XPHOZAH as the first and only phosphate absorption inhibitor for CKD patients on dialysis
- Unique mechanism of action blocking phosphate absorption at the primary pathway
- Convenient dosing of a single tablet twice daily
- Publication of plain language summaries to improve patient understanding of clinical trial results
- None.
Insights
The publication of plain language summaries for XPHOZAH® (tenapanor) clinical trials is a step towards improved patient understanding, but its immediate impact on Ardelyx's stock is likely minimal. Here's why:
- These summaries don't present new data, but rather repackage existing information from the NORMALIZE and OPTIMIZE trials for a broader audience.
- While valuable for patient education, this type of publication rarely moves the needle for investors unless it reveals previously undisclosed positive outcomes.
- The FDA has already approved XPHOZAH, so these summaries don't change the drug's market status or potential.
However, there are some potential long-term implications to consider:
- Improved patient understanding could lead to increased adoption of XPHOZAH, potentially boosting sales over time.
- This patient-centric approach might enhance Ardelyx's reputation among the chronic kidney disease community, which could indirectly benefit the company's market position.
- The publication in a peer-reviewed journal adds credibility to XPHOZAH's efficacy and safety profile, which may influence healthcare providers' prescribing decisions.
In conclusion, while this news is positive for patient education, it's unlikely to have a significant immediate impact on Ardelyx's stock price. Investors should focus more on upcoming sales figures and market penetration data for XPHOZAH to gauge its commercial success.
WALTHAM, Mass., July 31, 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 the publication of plain language summaries of results from two clinical trials on XPHOZAH® (tenapanor), NORMALIZE and OPTIMIZE, in Current Medical Research and Opinion. The plain language summaries were developed by the authors to help adult patients with chronic kidney disease receiving dialysis, and their family members and caregivers, better understand some of the safety and efficacy data related to XPHOZAH.
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, blocking phosphate absorption at the primary pathway and is administered as a single tablet taken twice daily.
“We are proud to provide the clinical trials results for both the NORMALIZE and OPTIMIZE studies to patients in a format that is both useful and relevant to their needs. Plain language summaries, like these, help patients and their caregivers better understand their options and the potential impact XPHOZAH may have on lowering their serum phosphorus levels,” said Laura Williams, MD MPH, chief medical officer of Ardelyx. “Our entire Ardelyx team would like to express our gratitude to the patients who participated in these clinical trials, whose contributions are now helping other patients better understand the complications associated with elevated serum phosphorus and this new treatment option. We would also like to recognize the study authors who worked with our partners in the patient advocacy community to ensure that these plain language summaries could be made available to our patients.”
Current Medical Research and Opinion is an international journal that publishes research focused on new and existing drugs and therapies, best practices in patient care, developments in diagnostic medicine and medical technology, and innovations in medical and scientific publishing. The first article, titled “Tenapanor improves long-term control of high phosphate concentrations in the blood in patients receiving maintenance dialysis: a plain language summary of the NORMALIZE study,” describes results from the NORMALIZE study, is available online and can be found here. The second article, titled “Effectiveness of tenapanor for treating hyperphosphatemia in patients receiving dialysis: a plain language summary of the OPTIMIZE study” provides a review of the OPTIMIZE study, is available online and can be found here. Both articles are summaries of data originally published in Kidney360.
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 NORMALIZE
Patients completing the Phase 3 PHREEDOM trial from both the XPHOZAH arm and the sevelamer safety control arm had the option to participate in NORMALIZE, an open-label 18-month extension study. Patients entering the study from the XPHOZAH arm with serum phosphate levels in the normal range were followed with no medication changes. Patients entering the study from the XPHOZAH arm with serum phosphate greater than 4.5 mg/dL had sevelamer tablets added incrementally to achieve normal serum phosphate levels. Patients entering the study from the sevelamer safety control arm had XPHOZAH tablets added to their treatment regimen while reducing sevelamer tablets based on their serum phosphate value to achieve normal serum phosphate levels. The primary objective of the study was to evaluate the ability of XPHOZAH alone or in combination with sevelamer to achieve serum phosphate levels within the normal range (2.5 to 4.5 mg/dL) in patients with CKD on maintenance dialysis whose serum phosphate levels were greater than 6.0 mg/dL at baseline.
About OPTIMIZE
OPTIMIZE was a randomized, open label study, which included 330 patients with chronic kidney disease (CKD) on dialysis with hyperphosphatemia. The study was designed to evaluate different methods of initiating XPHOZAH to optimize phosphorus management in both binder-naïve and binder-treated patients. The objective was to evaluate the ability of XPHOZAH, with its novel blocking mechanism, administered as core therapy for the treatment of hyperphosphatemia in adult patients with chronic kidney disease (CKD) on dialysis, alone or in combination with phosphate binders, to achieve target serum phosphorus (s-P) levels ≤5.5 mg/dL. The study enrolled patients with s-P >5.5 and ≤10.0 mg/dL during stable phosphate binder treatment which were randomized in a 1:1 ratio to two different treatment cohorts, as well as patients who were phosphate binder naïve with s-P >4.5 and ≤10.0 mg/dL in a third cohort.
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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