--Comprehensive datasets demonstrate tenapanor's ability to control serum phosphorous in patients with chronic kidney disease (CKD) on dialysis--
FREMONT, Calif., Oct. 12, 2020 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with kidney and cardiovascular diseases, today announced that five abstracts on tenapanor have been accepted for presentation at Kidney Week 2020, the American Society of Nephrology's (ASN) Annual Meeting, to be held October 22-25, 2020. Tenapanor, which was discovered and developed by Ardelyx, is a first-in-class therapy under review for potential marketing approval by the U.S. Food and Drug Administration (FDA) for the control of serum phosphorus in adult patients with CKD on dialysis.
Three poster presentations highlight data from several Phase 3 trials in the U.S., including the BLOCK, AMPLIFY and PHREEDOM studies. Additionally, the company's partner for tenapanor in Japan, Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE:4151), will present results from two Phase 2 studies evaluating the efficacy and safety of tenapanor in Japanese patients on hemodialysis.
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: | Long-term Safety and Efficacy of Tenapanor for the Control of Serum Phosphorus in Patients with CKD on Dialysis |
Abstract Number: | 3450189 |
ePoster Number: | PO0384 |
Date/Time: | Thursday, October 22, 10:00 a.m. EDT |
Title: | Efficacy of Tenapanor for the Control of Serum Phosphorus in Patients with CKD on Dialysis: Novel Mechanism of Action Allows for Both Monotherapy and Dual Mechanism Approach |
Abstract Number: | 3450673 |
ePoster Number: | PO0374 |
Date/Time: | Thursday, October 22, 10:00 a.m. EDT |
Title: | Tolerability of Tenapanor, an Investigational, First-in-Class, Non-Binder Therapy for the Control of Serum Phosphorus in Patients with CKD on Dialysis |
Abstract Number: | 3450921 |
ePoster Number: | PO0376 |
Date/Time: | Thursday, October 22, 10:00 a.m. EDT |
Kyowa Kirin Poster Presentations: | |
Title: | Dose-Response Efficacy and Tolerability of Tenapanor on Hyperphosphatemia in Japanese Hemodialysis Patients: Results of a Randomized Phase 2 Study |
Abstract Number: | 3435825 |
ePoster Number: | PO0382 |
Date/Time: | Thursday, October 22, 10:00 a.m. EDT |
Title: | Efficacy and Safety of Add-on Tenapanor to Phosphate Binders for Refractory Hyperphosphatemia in Japanese Patients on Hemodialysis: A Phase 2, Double-Blind Study |
Abstract Number: | 3439266 |
ePoster Number: | PO0375 |
Date/Time: | Thursday, October 22, 10:00 a.m. EDT |
About our Partnership with Kyowa Kirin Kyowa Kirin is a Japan-based global specialty pharmaceutical company committed to innovative drug discovery driven by state-of-the-art technologies. The company focuses on discovering and creating new value through advances in four therapeutic areas: nephrology, oncology, immunology/allergy and neurology. In 2017, Ardelyx entered into a license agreement that provides Kyowa Kirin exclusive rights to develop and commercialize tenapanor in Japan for the treatment of cardiorenal diseases. In addition, in 2019, the companies established a two-year research collaboration to advance two of Ardelyx's ongoing research programs focused on the identification and design of compounds for two undisclosed targets.
About Tenapanor for HyperphosphatemiaTenapanor, discovered and developed by Ardelyx, is a first-in-class, phosphate absorption inhibitor, for which an NDA is currently under review by the FDA (PDUFA date: April 29, 2021), for the control of serum phosphorus in adult patients with CKD on dialysis. Tenapanor has a unique mechanism of action that acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3). This results in a conformational change of the epithelial cell junctions, thereby significantly reducing paracellular uptake of phosphate at the primary pathway of phosphate absorption. Tenapanor has been studied in three Phase 3 clinical trials in the U.S., all of which have met their primary endpoint, and support the role of tenapanor as foundational treatment in the management of hyperphosphatemia.
About HyperphosphatemiaHyperphosphatemia 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. Despite treatment with phosphate binders (the only approved therapy for hyperphosphatemia), 77% of CKD patients on dialysis are unable to consistently maintain phosphorus levels ≤5.5 mg/dL over a six-month period (Spherix Global Insights: RealWorld Dynamix, Dialysis 2019). Phosphorus levels greater than 5.5 mg/dL have been shown to be an independent risk factor for cardiovascular morbidity and mortality in patients requiring dialysis (Block 2004), and internationally recognized treatment guidelines recommend lowering elevated phosphate levels toward the normal range (