National Kidney Foundation and Ardelyx, Inc. Survey Finds Dialysis Patients Struggle to Maintain Serum Phosphorus Levels

Majority of survey respondents call for new treatments to help manage phosphorus levels

WALTHAM, Mass. and NEW YORK, Nov. 4, 2022 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX) in partnership with the National Kidney Foundation (NKF), today announced results from a survey of patients with chronic kidney disease (CKD) on dialysis conducted to better understand patients' experience managing serum phosphorus levels. The survey found that more than 80% of respondents struggle to manage their serum phosphorus levels, with more than 90% citing a need for new treatment options.

"Despite best efforts with current treatment strategies, a significant proportion of patients have persistent hyperphosphatemia, placing them at an increased risk for mineral and bone disorder complications, including vascular disease," said Joseph Vassalotti, MD, chief medical officer for the National Kidney Foundation. "These survey results point to the difficulty people living with kidney diseases treated with dialysis have coping with low phosphorus diet and current medication schedules."

"We are proud to bring the patient voice to this important conversation," said Laura A. Williams, MD, chief medical officer of Ardelyx. "The idea for this survey, born from the Ardelyx Patient Advisory Council, provides great insight into the challenges patients face managing hyperphosphatemia and supports the need for innovation in this space. As a company committed to putting patients first, and as a CKD patient myself, we are proud of this collaborative effort that truly captures the voice of patients with kidney disease on dialysis."

Hyperphosphatemia is a serious condition resulting in an abnormally elevated level of phosphorus in the blood that is estimated to affect more than 745,000 dialysis patients in major developed countries. Currently, dialysis patients are often prescribed phosphate binders, the only class of medicine currently available to treat hyperphosphatemia and control elevated serum phosphorus levels, which require very frequent dosing of several large pills multiple times per day with meals.

Survey findings reveal the daily burden dialysis patients face as they, in partnership with their physicians, try to control their serum phosphorus levels, including:

• Only 18% of patients reported consistently maintaining their phosphorus within range on a monthly basis
• 89% found that it takes effort to manage their phosphorus, with 86% reporting at least some difficulty following a low phosphorus diet
• 88% reported at least some difficulty taking phosphate binders, with 60% reporting side effects from their phosphate binder pills, including nausea, diarrhea, constipation, and vomiting.
• 92% noted a need for a better way to manage their phosphorus levels

The survey, a collaborative effort, was conducted by the National Kidney Foundation and sponsored by the Ardelyx, Inc., Patient Advisory Council, was conducted online between September 28, 2022 – October 8, 2022, evaluating 475 dialysis patients who are currently prescribed phosphate binders and take an average of seven binders per day participated in the survey.

Full results of the survey will be presented during an upcoming webinar. Please visit paracellularpathway.com for additional information on hyperphosphatemia.

The National Kidney Foundation (NKF) is the largest, most comprehensive, and longstanding patient-centric organization dedicated to the awareness, prevention, and treatment of kidney disease in the U.S. For more information about NKF, visit www.kidney.org.

Ardelyx was founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx's first approved product, IBSRELA® (tenapanor) is available in the United States and Canada. Ardelyx is developing XPHOZAH® (tenapanor), a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis, which has completed three successful Phase 3 trials. Ardelyx has a Phase 2 potassium lowering compound, RDX013, for the potential treatment of elevated serum potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease and an early-stage program in metabolic acidosis, a serious electrolyte disorder in patients with CKD. Ardelyx has established agreements with Kyowa Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada for the development and commercialization of tenapanor in their respective territories.

SOURCE Ardelyx