Ardelyx to Present New Data on XPHOZAH® for Dialysis Patients at NKF 2024
Ardelyx Inc., a biopharmaceutical company listed on Nasdaq as ARDX, announced new data supporting XPHOZAH® (tenapanor) that will be presented at the National Kidney Foundation (NKF) 2024 Spring Clinical Meetings, taking place from May 14-18, 2024, in Long Beach, California. XPHOZAH is the pioneering phosphate absorption inhibitor (PAI) approved by the U.S. Food and Drug Administration to reduce serum phosphorus in adults with chronic kidney disease (CKD) undergoing dialysis. It is intended for patients who do not respond adequately to phosphate binders or cannot tolerate any dose of phosphate binder therapy. XPHOZAH works by blocking phosphate absorption at the primary pathway and is administered as a single tablet taken twice daily.
At the NKF 2024 Spring Clinical Meetings, three poster presentations will highlight different aspects of XPHOZAH's efficacy and patient response:
1. Title: Tenapanor Treatment Added to Phosphate Binders Improved Long-Term Serum Phosphate (P) Control as Measured by Reduction in Average Daily P Area Under the Curve
- Authors: Kevin J. Martin, David M. Spiegel, Yang Yang, David Rosenbaum, Susan Edelstein, Laura Williams
- Poster Number: 239
- Date/Time: May 15, 2024, from 5:30 PM to 7:00 PM PDT
2. Title: Treatment Response to Tenapanor Categorized by Age and Comorbidities: A Post Hoc Analysis of the PHREEDOM Study
- Authors: Daniel Weiner, David M. Spiegel, Yang Yang, David Rosenbaum, Susan Edelstein
- Poster Number: 243
- Date/Time: May 15, 2024, from 5:30 PM to 7:00 PM PDT
3. Title: Patient Perception of Phosphate-Lowering Treatment Regimen Improves Adherence to Therapy
- Authors: Amy Mosman, Susan Edelstein, David M. Spiegel, Suling Zhao, David Rosenbaum
- Poster Number: 240
- Date/Time: May 15, 2024, from 5:30 PM to 7:00 PM PDT
Additionally, Ardelyx is sponsoring an Exhibitor Showcase titled "A New Paradigm: Rethinking Hyperphosphatemia Management," scheduled on May 17, 2024, from 8:30-9:05 AM PDT. The session will feature Dr. David M. Spiegel and Lisa Gutekunst, who will discuss the mechanism, efficacy, and safety data of XPHOZAH, as well as its clinical application for dialysis patients with elevated serum phosphorus levels despite being on phosphate binders.
About XPHOZAH® (tenapanor):
XPHOZAH, developed by Ardelyx, is a groundbreaking phosphate absorption inhibitor that acts locally in the gut. By inhibiting the sodium hydrogen exchanger 3 (NHE3), it reduces phosphate absorption through the primary pathway in the digestive system. The medication is taken as a single tablet twice daily, with diarrhea being the most common side effect reported in clinical trials.
About Hyperphosphatemia:
Hyperphosphatemia, characterized by elevated phosphate levels in the blood, is prevalent among the 550,000 U.S. patients with chronic kidney disease on maintenance dialysis. The condition arises due to the kidneys' reduced ability to eliminate excess phosphate as kidney function deteriorates. According to KDIGO guidelines, it is crucial to lower elevated phosphate levels to the normal range (2.5-4.5mg/dL), as the kidneys fail to perform this function effectively in CKD patients on dialysis.
IMPORTANT SAFETY INFORMATION:
Contraindications:
- Pediatric patients under 6 years of age
- Patients with known or suspected mechanical gastrointestinal obstruction
Warnings and Precautions:
- Diarrhea: Treatment should be discontinued in patients who develop severe diarrhea.
Common Adverse Reactions:
- Diarrhea was reported in 43-53% of patients, primarily mild-to-moderate in severity and resolving over time or with dose reduction.
Indication:
- XPHOZAH (tenapanor), 30 mg, taken twice daily, is indicated to reduce serum phosphorus in adults with CKD on dialysis who have an inadequate response to or are intolerant of phosphate binders.
About Ardelyx:
Founded with the mission to discover, develop, and commercialize innovative, first-in-class medicines, Ardelyx has two FDA-approved products, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor), and a pipeline of early-stage candidates. Internationally, tenapanor is commercialized under different agreements, including Kyowa Kirin in Japan and Fosun Pharma in China. Knight Therapeutics manages the commercialization of IBSRELA in Canada.
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