Ardelyx Announces Poster Presentations on XPHOZAH® (tenapanor) at ASN's Kidney Week 2022
Ardelyx, Inc. (Nasdaq: ARDX) announced three poster presentations for its investigational phosphate absorption inhibitor, XPHOZAH (tenapanor), at the American Society of Nephrology Kidney Week 2022 from November 3-6 in Orlando, Florida. These posters will detail results from three Phase 3 trials involving adult patients with chronic kidney disease on dialysis. Collaborator Kyowa Kirin will also present findings from two Phase 3 trials in Japan. Tenapanor aims to manage hyperphosphatemia, affecting over 745,000 dialysis patients globally.
- Successful completion of three Phase 3 trials for XPHOZAH.
- Collaboration with Kyowa Kirin for expanded market presence in Japan.
- None.
WALTHAM, Mass., Oct. 20, 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 three posters will be presented at the American Society of Nephrology (ASN) Kidney Week 2022 to be held November 3-6, 2022, in Orlando, Florida. XPHOZAH (tenapanor), discovered and developed by Ardelyx, 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.
Three poster presentations highlight data from three Phase 3 trials (BLOCK, AMPLIFY and PHREEDOM) in patients with hyperphosphatemia on maintenance dialysis in the U.S. Additionally, the company's collaboration partner for tenapanor in Japan, Kyowa Kirin Co., Ltd. (Kyowa Kirin), will present key results from two Phase 3 studies of tenapanor in a similar patient population in Japan.
Information regarding ASN's Kidney Week, including copies of presentation abstracts, can be found at https://www.asn-online.org/education/kidneyweek.
Ardelyx Poster Presentations: | |
Title: | The Predictive Value of Early Response to Tenapanor for the Treatment of Hyperphosphatemia in Patients Receiving Maintenance Dialysis |
Abstract Number: | TH-PO163 |
Date/Time: | November 03, 2022, from 10:00 AM - 12:00 PM EDT |
Location: Exhibit Hall, Orange County Convention Center, West Building | |
Title: | Reduction of Serum Phosphorus (sP) With Tenapanor in Patients with Chronic Kidney Disease (CKD) on Dialysis With Severe Hyperphosphatemia |
Abstract Number: | TH-PO162 |
Date/Time: | November 03, 2022, from 10:00 AM - 12:00 PM EDT |
Location: Exhibit Hall, Orange County Convention Center, West Building | |
Title: | Tenapanor Plus Phosphate Bi nder Reduces Interdialytic Weight Gain (IDWG) in Patients with Chronic Kidney Disease (CKD) on Hemodialysis (HD): Post Hoc Analysis of the AMPLIFY Study |
Abstract Number: | SA-PO400 |
Date/Time: | November 05, 2022, from 10:00 AM - 12:00 PM EDT |
Location: Exhibit Hall, Orange County Convention Center, West Building | |
Kyowa Kirin Poster Presentations: | |
Title: | Efficacy and Safety of Tenapanor on Hyperphosphatemia in Japanese Hemodialysis Patients: Results of a Randomized Phase 3 Trial |
Abstract Number: | TH-PO160 |
Date/Time: | November 03, 2022, from 10:00 AM - 12:00 PM EDT |
Location: Exhibit Hall, Orange County Convention Center, West Building | |
Title: | 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 |
Abstract Number: | TH-PO161 |
Date/Time: | November 03, 2022, from 10:00 AM - 12:00 PM EDT |
Location: Exhibit Hall, Orange County Convention Center, West Building | |
In addition to the poster presentations during ASN, Ardelyx is sponsoring an Exhibitor Spotlight titled: The Phosphorus Management Puzzle and Need for New Pieces: the Patient and Physician Perspective, on Saturday November 5, 2022, from 12:30-1:15pm ET. During this Exhibitor Spotlight, Dr. Geoff Block, MD, associate chief medical director and senior vice president of clinical research and medical affairs at U.S. Renal Care and Dawn P. Edwards, patient ambassador, co-chair, national forum of ESRD networks kidney patient advisory council, will review the consequences of hyperphosphatemia, the current understanding of phosphate absorption, and the importance of managing hyperphosphatemia, including current management practices and inherent challenges. Dr. Block is also a member of Ardelyx's board of directors.
About XPHOZAH (tenapanor) for Hyperphosphatemia
XPHOZAH (tenapanor), discovered and developed by Ardelyx, is an investigational first-in-class phosphate absorption inhibitor (PAI). With its unique blocking mechanism of action, tenapanor 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 tenapanor in clinical trials was diarrhea.
About Hyperphosphatemia
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)
About Ardelyx, Inc.
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.
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SOURCE Ardelyx
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