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Ardelyx's tenapanor combo meets all key goals at Phase 3 in hyperphosphatemia patients on dialysis

Published on 04/09/19 at 12:11pm

Ardelyx has revealed that its small molecule, non-binder, phosphate absorption inhibitor tenapanor met all primary and key secondary endpoints at Phase 3 when used in combination with phosphate binders in the treatment of patients with chronic kidney disease (CKD) on dialysis whose hyperphosphatemia was not previously controlled with binders alone.

The data showed that, in the trial population of 236 patients, the combo produced a statistically significant mean reduction in serum phosphorus levels from baseline of 0.84mg/dL, compared to 0.19mg/dL for phosphate binders alone.

Additionally, the combo produced statistically significant decreases in serum phosphorus during all four weeks during all four weeks of treatment, with up to 49.1% of tenapanor patients achieving <5.5mg/dL serum phosphorus levels compared to 23.5% with phosphate binders alone.

“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,” explained Dr Glenn Chertow, 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.”

Ardelyx President and CEO Mike Raab also remarked: “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 treatment goal. We look forward to reporting results from our second Phase 3 monotherapy study, PHREEDOM, in the fourth quarter of this year. With additional positive results from that trial, we will complete our New Drug Application for tenapanor, encompassing two indications: monotherapy and combination therapy for the treatment of hyperphosphatemia. The promising results from AMPLIFY bring us one step closer to providing this important medicine to patients with CKD on dialysis.”

Matt Fellows

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