Ardelyx and Kyowa Kirin Highlight New Data Supporting the Clinical Safety and Efficacy of First-In-Class, Phosphate Absorption Inhibitor Tenapanor at ASN's Kidney Week 2020
Of the posters presented today, three highlight tenapanor clinical data from
Ardelyx Poster Presentations:
- ePoster #PO0384, entitled "Long-term Safety and Efficacy of Tenapanor for the Control of Serum Phosphorus in Patients with CKD on Dialysis," further summarizes data from PHREEDOM, a long-term Phase 3 U.S. study evaluating the safety and efficacy of tenapanor for the control of serum phosphorus in patients with CKD on dialysis. New details presented demonstrate that, within the efficacy analysis set, treatment with tenapanor resulted in sustained reductions in serum phosphorus concentrations, decreasing mean serum phosphorus from 7.7 mg/dL at baseline to 5.1 mg/dL at the end of the randomized treatment period.
- ePoster #PO0374, entitled "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," presents clinical data from two Phase 3 clinical trials, demonstrating that tenapanor reduces serum phosphorus when used as monotherapy in hyperphosphatemia patients with CKD on dialysis (BLOCK trial) and reduces serum phosphorus levels in patients with difficult-to-control hyperphosphatemia when used with phosphate binders as part of a dual-mechanism approach (AMPLIFY trial). The poster highlights the need for new strategies to manage hyperphosphatemia and suggests that tenapanor, with its novel mechanism of action, could offer a new treatment approach for patients with CKD on dialysis.
- ePoster #PO0376, entitled "Tolerability of Tenapanor, an Investigational, First-in-Class, Non-Binder Therapy for the Control of Serum Phosphorus in Patients with CKD on Dialysis," presents an in-depth analysis of the tolerability profile of tenapanor across three pivotal clinical studies, BLOCK, PHREEDOM, and AMPLIFY, concluding that tenapanor was generally well tolerated in all studies and that the overall gastrointestinal tolerability of tenapanor is consistent with its novel mechanism of action.
Kyowa Kirin Poster Presentations:
- ePoster #PO0382, entitled "Dose-Response Efficacy and Tolerability of Tenapanor on Hyperphosphatemia in Japanese Hemodialysis Patients: Results of a Randomized Phase 2 Study," concludes that tenapanor significantly decreased serum phosphorus levels in a dose-dependent manner, and was generally well tolerated across doses in Japanese patients. Compared to placebo, the 30mg BID dosing groups produced a statistically significant 2.6 mg/dL mean reduction (p<0.001) in serum phosphorus from baseline to the end of the six-week treatment period.
- ePoster #PO0375, entitled "Efficacy and Safety of Add-on Tenapanor to Phosphate Binders for Refractory Hyperphosphatemia in Japanese Patients on Hemodialysis: A Phase 2, Double-Blind Study," concludes that, the efficacy and safety of tenapanor with phosphate binders was consistent with other studies conducted in
Japanwhere tenapanor was administered as a single agent. Compared to placebo and phosphate binders, treatment with tenapanor and phosphate binders achieved a statistically significant 2.1 mg/dL mean reduction (p<0.001) in serum phosphorus, with 87% of patients in the tenapanor group achieving target phosphorus levels.
All poster presentations are now publicly available and can be accessed on demand HERE.
In addition to the poster presentations during the ASN Annual Meeting, an Exhibitor Spotlight presentation, sponsored by
"ADVANCING THE SCIENCE OF PHOSPHATE ABSORPTION: Paracellular Pathway and Implications for Phosphorus Management." Guest speakers focus on the following topics:
- New Understanding of Phosphate Absorption May Explain Challenges in Phosphorus Management
KAMYAR KALANTAR-ZADEH, MD, MPH, PhD, Professor of Medicine, Pediatrics, Public Health, Epidemiology, and Nursing Sciences, Chief, Division of Nephrology and Hypertensionand Kidney Transplantation, University of California, Irvine, School of Medicine
- Tenapanor: An Investigational Therapy for the Treatment of Hyperphosphatemia
GLENN M. CHERTOW, MD, MPH, Chief, Division of Nephrology Stanford University School of Medicine
To view the full presentation, click on the Ardelyx Exhibitor Spotlight program HERE.
About Tenapanor for Hyperphosphatemia
Tenapanor, discovered and developed by
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. 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 (<4.6mg/dL).
Ardelyx Forward Looking Statements
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Contacts for Ardelyx, Sylvia Wheeler (investors), Wheelhouse Life Science Advisors, firstname.lastname@example.org; Alex Santos (media), Wheelhouse Life Science Advisors, email@example.com; Contacts for Kyowa Kirin, Media, Hiroki Nakamura, +81-3-5205-7205, E-mail: firstname.lastname@example.org