Ardelyx Presents New Data Analyses at Kidney Week 2022, Further Supporting the Clinical Relevance of XPHOZAH® (tenapanor), an Investigational, Phosphate Absorption Inhibitor to Control Serum Phosphorus in Adult Patients with Chronic Kidney Disease on Dialysis

XPHOZAH monotherapy lowers serum phosphorus with early responders maintaining response with continued treatment

XPHOZAH monotherapy meaningfully reduced serum phosphorus in patients with severe hyperphosphatemia

XPHOZAH in combination with phosphate binders reduced patients’ interdialytic weight gain compared to binders alone

Excerpt from the Press Release:

WALTHAM, Mass., Nov. 3, 2022 /PRNewswire/ — 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 that new analyses of data from its three Phase 3 trials supporting the clinical utility of XPHOZAH (tenapanor) will be presented at the American Society of Nephrology (ASN) Kidney Week 2022, taking place in Orlando, Florida from November 3-6, 2022. XPHOZAH is an investigational first-in-class phosphate absorption inhibitor (PAI) for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.

“These data continue to support the benefit that novel-mechanism XPHOZAH could have for patients on dialysis with hyperphosphatemia,” said David Rosenbaum, Ph.D., chief development officer for Ardelyx. “Notably, early response to XPHOZAH was found to be predictive of continued response throughout the treatment period. This information could help guide treatment decisions that maximize the potential therapeutic benefit of XPHOZAH for these patients. With over 1,100 patients treated with XPHOZAH in clinical studies in the U.S. as well as clinical data generated by our partner Kyowa Kirin in Japan, we believe the impact that this first-in-class treatment could have for CKD patients on dialysis is clear.”

New Clinical Analyses Being Presented by Ardelyx:

Poster # PO163 titled “The Predictive Value of Early Response to Tenapanor for the Treatment of Hyperphosphatemia in Patients Receiving Maintenance Dialysis” was based on a post hoc analysis of the Phase 3 PHREEDOM study evaluating if an early reduction in serum phosphorous (sP) following treatment with XPHOZAH would predict continued control of sP during subsequent treatment.

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