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Ardelyx Announces Positive Results from the Pivotal Phase 3 AMPLIFY Study Evaluating Tenapanor in Dialysis Patients Who Have Uncontrolled Hyperphosphatemia Despite Phosphate Binder Treatment
FREMONT, Calif., Sept. 3, 2019 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a specialized biopharmaceutical company focused on developing first-in-class
About this update from Ardelyx, Inc.
[{"type":"text","content":"FREMONT, Calif., Sept. 3, 2019 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with cardiorenal diseases, today reported positive results from AMPLIFY, a pivotal Phase 3 study of tenapanor in combination with phosphate binders in patients with chronic kidney disease (CKD) on dialysis whose hyperphosphatemia was not previously controlled with binders alone. The AMPLIFY study met the primary endpoint and all key secondary endpoints, including demonstrating a statistically significant (p=0.0004) reduction in serum phosphorus levels for patients treated with tenapanor and phosphate binders compared to phosphate binders alone. Tenapanor is an investigational, first-in-class, small molecule, non-binder, phosphate absorption inhibitor being developed to treat hyperphosphatemia in patients with CKD on dialysis.\n\n \n\"I believe tenapanor has the potential to change the landscape of hyperphosphatemia treatment – finally, a novel agent that can lower serum phosphorus alone or in conjunction with binders,\" said Glenn Chertow, M.D., M.P.H., division chief of nephrology and professor of medicine at Stanford University. \"Faced with an extremely high mortality rate of approximately 18% per year in dialysis patients, we are very focused on managing and treating elevated serum phosphorus. Elevated serum phosphorus is associated with mortality, cardiovascular events and bone fracture among patients receiving dialysis, and more than half of patients cannot achieve control of hyperphosphatemia despite taking a fist full of binders three times daily with meals. The AMPLIFY study results provide convincing evidence that controlling hyperphosphatemia will soon be within our reach.\" \nMike Raab, president and chief executive officer of Ardelyx added, \"We are thrilled with the positive results from the AMPLIFY study demonstrating that tenapanor can help significantly more patients achieve the established serum phosphorus treatment goal of less than 5.5 mg/dL. This result is striking as serum phosphorus levels above 5.5 mg/dL are associated with increased mortality. For too long, hyperphosphatemia management has been an enormous challenge for patients and clinicians. With tenapanor, patients may finally be able to achieve their treatm...