Ardelyx : Post-Hoc Analysis of the OPTIMIZE Study Supporting XPHOZAH to be Presented

Published 2025-04-10, 04:06 p/m

Ardelyx, Inc. (Nasdaq: 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 the company will present a post-hoc analysis of the OPTIMIZE Study, an open-label clinical trial of XPHOZAH ® (tenapanor), as a poster at the National Kidney Foundation (NKF) Spring Clinical Meetings, now underway in Boston. Ardelyx is also hosting an Exhibitor Showcase discussing hyperphosphatemia management.

XPHOZAH is the first and only phosphate absorption inhibitor (PAI) 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.

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 optimizing phosphorus management with XPHOZAH in both binder-naïve and binder-treated patients.

“Now more than one year since the launch of XPHOZAH, we are seeing that patients are receiving the benefits of the treatment and experiencing improved phosphate control,” said David Spiegel, MD, senior vice president, nephrology at Ardelyx. “At the same time, we recognize how important it is to continue to understand the patient experience and provide insights in how to help patients have a positive experience with the therapy to support adherence to treatment and achieve target phosphate goals. Analyses, like the one presented at NKF Spring Clinical Meetings, provide insight into methods that healthcare providers can use to optimize treatment with XPHOZAH. In this case, it was observed that among patients experiencing loose stools on XPHOZAH, those who used an anti-diarrheal medication had a lower rate of treatment discontinuation due to diarrhea.”

Poster #G-310, entitled “Tenapanor-Treated Patients Using Over-the-Counter Antidiarrheal Agents Saw Decreased Stool Frequency and Improved Stool Consistency,” is a post hoc analysis of the OPTIMIZE study and evaluated discontinuation rates and changes in stool frequency and consistency in patients receiving tenapanor who self-medicated with the over-the-counter antidiarrheal agent loperamide. The analysis found that among the 40% of patients with reported diarrhea, 9.7% of patients that were also using loperamide discontinued tenapanor due to diarrhea compared to 24.6% of patients not using loperamide. In conclusion, loperamide was identified as a treatment option to improve diarrhea emergent with tenapanor treatment.

Poster presentations are now publicly available and can be accessed on demand here.

In addition to the poster presentation during NKF Spring Clinical Meetings, Ardelyx is sponsoring an Exhibitor Showcase titled: “A Different Perspective on Hyperphosphatemia Management: Evaluating Current Strategies” on April 11, 2025, from 12:00-12:35 PM EDT, where Dr. Vincent Carsillo, 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.

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