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Ardelyx Reports Additional Positive Data Supporting Clinical Utility of Tenapanor at ASN's Kidney Week 2021
- First patient reported outcome data on tenapanor from OPTIMIZE trial demonstrates improved overall patient experience and benefit of one pill twice daily
About this update from Ardelyx, Inc.
[{"type":"text","content":"- First patient reported outcome data on tenapanor from OPTIMIZE trial demonstrates improved overall patient experience and benefit of one pill twice daily dosing regimen with tenapanor compared to binder therapies\n - Post-hoc analysis shows comparable phosphate lowering in patients undergoing hemodialysis (HD) and peritoneal dialysis (PD) with a mean change from baseline to week 26 of -1.70 mg/dL in PD group\n - Additional post-hoc analysis shows that in a subset of patients with severe hyperparathyroidism, tenapanor lowers parathyroid hormone and fibroblast growth factor 23 levels\n - Tenapanor novel mechanism of action shown to selectively decrease serum phosphorus by inhibiting paracellular phosphate absorption, without impacting other serum electrolytes (sodium, bicarbonate, chloride, potassium, calcium, magnesium) or albumin\n\n\nFREMONT, Calif. and WALTHAM, Mass., Nov. 5, 2021 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today announced multiple presentations covering additional positive clinical observations with tenapanor at the American Society of Nephrology Kidney Week 2021 (ASN Kidney Week), which is taking place virtually November 4 - November 7, 2021. Ardelyx has completed three successful Phase 3 pivotal trials, and an additional clinical trial (OPTIMIZE) for tenapanor, an investigational, first-in-class phosphate absorption inhibitor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. Tenapanor was discovered and developed by Ardelyx. \n\n \n \n \n \n \n \n\n \n\"These data provide additional perspective on the potential benefits of tenapanor and further support its utility in the management of serum phosphorus,\" said Laura Williams, M.D., MPH, chief medical officer for Ardelyx. \"We continue to pursue approval of this first-in-class, novel therapy which we believe represents an important innovation for the nephrology community.\"\n\"As a person living with kidney disease who has struggled with managing phosphorus, it gives me great hope to see the patient perspective and patient priorities being incorporated into clinical studies,\" said Derek Forfang, chair, NKF Kid...