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 Dial
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
"These data continue to support the benefit that novel-mechanism XPHOZAH could have for patients on dialysis with hyperphosphatemia," said
New Clinical Analyses Being Presented by
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. Among patients who responded to XPHOZAH (>1.2 mg/dL decrease in sP from baseline) within the first month and remained on treatment, approximately 80% continued to have at least a 1.2 mg/dL decrease in sP from baseline during weeks 17-26 of the treatment period.
Poster # PO162 titled "Reduction of Serum Phosphorus (sP) with Tenapanor in Patients with Chronic Kidney Disease (CKD) on Dialysis with Severe Hyperphosphatemia" presented post hoc analyses of the two Phase 3 monotherapy studies BLOCK and PHREEDOM to determine the effect of XPHOZAH monotherapy on dialysis patients with severe hyperphosphatemia, which was defined as having a baseline sP ≥7.5 mg/dL. Patients with severe hyperphosphatemia from the BLOCK and PHREEDOM studies had clinically meaningful mean sP reductions of 1.78 and 1.94 mg/dL, respectively, from baseline to the end of the randomized treatment periods or last assessment.
Poster # PO400 titled "Tenapanor Plus Phosphate Binder Reduces Interdialytic Weight Gain (IDWG) in Patients with Chronic Kidney Disease (CKD) on Hemodialysis (HD): Post Hoc Analysis of the AMPLIFY Study" examined pre-HD weights in patients to assess whether treatment with XPHOZAH in combination with phosphate binders decreased IDWG, which is associated with adverse patient outcomes, as compared with patients treated with phosphate binders alone. At week 4, the mean pre-HD weight decreased in patients whose treatment included XPHOZAH, while it increased in patients who received phosphate binders alone.
Ardelyx Exhibitor Spotlight Presentation:
In addition to the poster presentations highlighting tenapanor clinical data,
Clinical Data Being Presented by Kyowa Kirin Co., Ltd. (Kyowa Kirin):
Kyowa Kirin, the company's collaboration partner for tenapanor in
- Poster # PO160 titled "Efficacy and Safety of Tenapanor on Hyperphosphatemia in Japanese Hemodialysis Patients: Results of a Randomized Phase 3 Trial"
- Poster # PO161 titled "Efficacy and Safety of Tenapanor Added to Phosphate Binders for Hemodialysis Patients Who Have Poorly Controlled Hyperphosphatemia on Existing Phosphate Binders: Results of a Randomized Phase 3 Trial"
XPHOZAH (tenapanor), discovered and developed by Ardelyx, is an investigational first-in-class phosphate absorption inhibitor (PAI). With its unique blocking mechanism of action, XPHOZAH acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), reducing phosphate absorption through the paracellular pathway, the primary pathway of phosphate absorption. This novel blocking mechanism enables a one 30 mg tablet BID dosing regimen. The most common side effect with XPHOZAH in clinical trials was diarrhea.
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. The kidney is the organ responsible for regulating phosphorus levels, but when kidney function is significantly impaired, phosphorus is not adequately eliminated from the body. As a result, hyperphosphatemia is a nearly universal condition among people with CKD on dialysis with internationally recognized KDIGO treatment guidelines that recommend lowering elevated phosphate levels toward the normal range (2.5-4.5 mg/dL).
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding
View original content to download multimedia:https://www.prnewswire.com/news-releases/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-chron-301667715.html
Investor and Media Contacts: Kimia Keshtbod, firstname.lastname@example.org, Sylvia Wheeler, Wheelhouse Life Science Advisors, email@example.com, Alex Santos, Wheelhouse Life Science Advisors, firstname.lastname@example.org