This morning clinical-stage biopharmaceutical developer of medicines for the treatment of cardiorenal diseases Ardelyx Inc. (ARDX:NASDAQ) announced positive results from the company's pivotal Phase 3 AMPLIFY study evaluating tenapanor in dialysis patients who have uncontrolled hyperphosphatemia despite phosphate binder treatment.
The AMPLIFY Study was a double-blind, placebo-controlled, randomized study that enrolled a total of 236 patients with chronic kidney disease (CKD) on dialysis, who despite a stable phosphate binder regimen, had a serum phosphorus level greater than or equal to 5.5 mg/dL and less than or equal to 10.0 mg/dL at screening.
The study findings indicated that the primary and all key secondary endpoints were met. Tenapanor in combination with binders met the primary endpoint demonstrating a statistically significant (p=0.0004) reduction of serum phosphorus compared to binders alone. Approximately two times more patients achieved the established serum phosphorus treatment goal of less than 5.5mg/dL in the tenapanor arm compared to binders alone (p-values ≤0.0097) for each week of treatment. The study also showed that tenapanor was well tolerated with only 4.3% of patients in the tenapanor arm discontinuing treatment compared to 2.5% in the binder arm.
Glenn Chertow, M.D., M.P.H., division chief of nephrology and professor of medicine at Stanford University, commented on the study's findings, "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...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...The AMPLIFY study results provide convincing evidence that controlling hyperphosphatemia will soon be within our reach."
Ardelyx's President and CEO Mike Raab 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...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."
The firm states that it discovered and developed tenapanor, a first-in-class, proprietary, oral, medicine in late-stage clinical development for the control of serum phosphorus in patients with CKD on dialysis, and claims that tenapanor has a unique mechanism of action and acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3). The firm believes that, if approved, tenapanor can become a foundational therapy for all CKD patients on dialysis who experience elevated serum phosphorus. 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.
Ardelyx is a clinical-stage biopharmaceutical company based in Fremont, Calif., focused on addressing cardiorenal and gastrointestinal (GI) diseases. The firm's cardiorenal pipeline includes the Phase 3 development of tenapanor for the treatment of hyperphosphatemia in people with CKD on dialysis, and RDX013, a potassium secretagogue program for the potential treatment of high potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease. The company also states that it has also completed Phase 3 development of tenapanor for the treatment of irritable bowel syndrome with constipation (IBS-C) and submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for the treatment of patients with IBS-C, which has been granted a target action date under the Prescription Drug User Fee Act (PDUFA) of September 12, 2019.
ARDX shares opened higher today after the holiday weekend at $4.01 (+$0.61, +17.94%) over Friday's close of $3.40. Since the open shares have traded between $3.77 and $5.72, setting a 52-week high price on much higher than average volume. At present, the stock is trading at $5.60 (+$2.21, +65.00%).
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