Ardelyx Presents New Data on XPHOZAH® (tenapanor) at ASN's Kidney Week

WALTHAM, Mass., Oct. 24, 2024 – Ardelyx, Inc., a biopharmaceutical company committed to discovering, developing, and commercializing first-in-class medicines for significant unmet medical needs, announced new data highlighting positive clinical observations of XPHOZAH® (tenapanor) at the American Society of Nephrology’s (ASN) Kidney Week in San Diego. Ardelyx is also hosting a discussion on managing hyperphosphatemia.

XPHOZAH, the only phosphate absorption inhibitor (PAI) approved by the U.S. FDA, is designed to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis who have not adequately responded to phosphate binders or are intolerant to them. The medication functions by blocking phosphate absorption at the primary pathway and is taken as a single tablet twice daily.

David Spiegel, MD, Senior Vice President of Nephrology at Ardelyx, emphasized the importance of XPHOZAH, stating, “We are excited to enhance our understanding of the impactful role XPHOZAH plays in helping CKD patients on dialysis manage elevated phosphorus levels.” He noted that dialysis patients and their healthcare providers have long faced challenges in maintaining serum phosphate levels within the recommended guidelines, and XPHOZAH provides a crucial tool for phosphate management.

Poster #TH-PO164, titled “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,” presents a post-hoc analysis from the PHREEDOM Phase 3 clinical trial. This analysis explored whether long-term phosphate control, measured via average phosphate area under the curve (P AUC) with tenapanor, correlates with lower iFGF23 levels, which are linked to increased cardiovascular mortality in CKD patients. The results indicated that better phosphate control is associated with greater reductions in iFGF23 levels.

Another poster, #TH-PO169, titled “Tenapanor Reduces Serum Phosphate With Similar Efficacy and Tolerability Profiles When Added to Various Phosphate Binders,” analyzed data from the AMPLIFY Phase 3 clinical trial and OPTIMIZE open-label clinical trial. The study examined the efficacy and tolerability of tenapanor when combined with different phosphate binders (PBs). Findings revealed that adding tenapanor to PBs resulted in a significant reduction in serum phosphate levels, with consistent efficacy and tolerability across different PB types.

These poster presentations are now available to the public for on-demand access. Additionally, Ardelyx is sponsoring an Exhibitor Spotlight session titled “A Different Perspective on Hyperphosphatemia Management: Evaluating Current Strategies,” on October 25, 2024. During this session, Steven Fishbane, MD, will review XPHOZAH, discussing its mechanism of action, efficacy, and safety data from the Phase 3 clinical trials, along with its clinical application as add-on therapy for dialysis patients whose phosphate binder treatment is insufficient.

XPHOZAH, discovered and developed by Ardelyx, is a first-in-class phosphate absorption inhibitor that works locally in the gut to inhibit the sodium-hydrogen exchanger 3 (NHE3), thereby reducing phosphate absorption through the primary pathway. It is taken twice daily as a single tablet. During clinical trials, diarrhea was the most common side effect experienced by patients.

Hyperphosphatemia, characterized by elevated phosphate levels in the blood, affects most of the 550,000 CKD patients in the U.S. on maintenance dialysis. Since the kidneys’ ability to eliminate excess phosphate declines with kidney function, nearly all CKD patients on dialysis have hyperphosphatemia. Treatment guidelines recommend lowering phosphate levels to the normal range (2.5-4.5mg/dL).

IMPORTANT SAFETY INFORMATION

XPHOZAH should not be used in pediatric patients under 6 years of age or in patients with known or suspected mechanical gastrointestinal obstruction. Severe diarrhea can occur, necessitating discontinuation of treatment. Diarrhea was the most frequently reported adverse reaction in clinical trials, affecting 43-53% of patients, mostly in a mild-to-moderate form and usually resolving over time or with dose reduction.

Ardelyx is dedicated to developing innovative medicines to address unmet medical needs. They have two U.S.-approved products, IBSRELA® and XPHOZAH®. Partnerships for tenapanor’s development and commercialization exist outside the U.S., including Japan, China, and Canada.