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Phase 3 PHREEDOM Trial for Hyperphosphatemia

Tenapanor was evaluated in a second Phase 3 trial, the PHREEDOM trial, for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis, with positive topline results reported December of 2019. PHREEDOM is a one-year study with a 26-week open-label treatment period and a 12-week double-blind, placebo-controlled randomized withdrawal period followed by a 14-week open-label safety extension period. An active safety control group, for safety analysis only and consistent with other Phase 3 registration studies for hyperphosphatemia, received sevelamer, open-label, for the entire 52-week study period. This trial follows a successful Phase 3 clinical trial completed in 2017, which achieved statistical significance for the primary endpoint. Tenapanor, if approved, would be the first therapy for phosphate management that is not a phosphate binder. As tenapanor is a novel, potent, small molecule there would be significantly less pill burden than the phosphate binders with simple twice daily dosing which we believe could greatly improve patient adherence and compliance and free patients from having to take pills before every meal.
Patients completing the PHREEDOM trial from both the tenapanor arm and the sevelamer active safety control arm had the option to participate in NORMALIZE, an ongoing open-label 18-month extension study. The goal of this study is to obtain real-world evidence regarding the dual mechanism of tenapanor and sevelamer to reduce patients’ serum phosphorus levels to normal (<4.6 mg/dL) while minimizing medication burden. Patients entering the study from the tenapanor arm with serum phosphorus levels in the normal range are followed with no medication changes. Patients entering the study from the tenapanor arm with serum phosphorus 4.6 mg/dL have sevelamer tablets added incrementally to achieve normal serum phosphorus levels. Patients entering the study from the sevelamer active safety control arm have tenapanor tablets added to their treatment regimen and have sevelamer tablets withdrawn based on their serum phosphorus value, to achieve normal serum phosphorus levels. In this initial analysis, 96% of eligible patients have chosen to enroll into NORMALIZE. Of the 73 patients thus far treated for more than one month of treatment, 42% have achieved normal serum phosphorus of less than 4.6 mg/dL and of those, 58% have accomplished this with either tenapanor alone or with tenapanor in combination with only one to three sevelamer tablets per day. These data represent a 45% improvement compared to current treatment practice data reported in the June 2019 Dialysis Outcomes Practice Patterns Study (DOPPS) Practice Monitor.

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End-Stage Renal Disease (ESRD): the final stage of chronic kidney disease, occurring when a person’s kidneys can no longer support the body’s needs to remove waste and excess fluid from the body. The most common causes of ESRD in the U.S. are diabetes and high blood pressure, and it is often treated with dialysis.

Hyperphosphatemia: the medical term for an abnormally elevated level of phosphorus in the blood. Phosphorus is one of the most abundant and essential elements in the body, and plays an important role in multiple biological processes. The kidney is the major organ involved in regulating phosphorus levels in the body. When kidney function is impaired, phosphorus is not excreted adequately from the body. Therefore, hyperphosphatemia is a common condition associated with ESRD in people receiving dialysis.



ESRD patients with hyperphosphatemia (HP) in major developed countries1


of U.S. dialysis patients taking phosphate binders to manage HP2


to manage HP; half are phosphate binders3


of patients are non-compliant with current treatments4


available that are not phosphate binders4

1. USRDS 2014; European ERA-EDTA Registry Annual Report 2012; Nakai S, et al, 2008. includes U.S. EU and Japan.2. Decision Resources 2015 3. Chiu 20094. Lederer 2016

Learn More About Phosphorus and the Importance of Its Management



Chronic Kidney Disease (CKD): a condition characterized by gradual loss of kidney function over time. CKD can be caused by diabetes, high blood pressure and other disorders. CKD also increases a person’s risk of having cardiovascular disease. As CKD progresses, it can lead to kidney failure, which ultimately requires dialysis or a kidney transplant.

Hyperkalemia (HK): the medical term that describes a potassium level in a person’s blood that is higher than normal. Potassium is a nutrient that is critical to the function of nerve and muscle cells, including those in the heart. HK does not affect all patients in the same manner and there is no single threshold which is considered dangerous; however, having a blood potassium level higher than 5.0mEq/L can be life threatening and requires immediate treatment. People with heart failure, CKD and diabetes are at the greatest risk of developing HK due to side effects of the drugs these patients take to manage their underlying disease and the kidney’s weakened ability to excrete excess potassium as a result of these conditions.



people in the U.S. with CKD and/or heart failure have HK1


with RAAS inhibitors remains standard and problematic part of treatment management among physicians2


common with high blood pressure and some anti-diabetic treatments3


leads to poor patient compliance4


emerging, but unaddressed by today’s treatment5

1. Einhom et al, 2009, HF; M. RDX-022 Market Opportunity – Spherix – 2015-07-08.pptx. Independent Market Research, Spherix Global Insights2. Maggioni 20133. Kovesday 2015, Jain 2012, Chaing 20164. Tomino 2007 5. Perleberg 2016 and ARDX research


Irritable Bowel Syndrome with Constipation (IBS-C): a gastrointestinal disorder characterized by significant abdominal pain and constipation (when a bowel movement is difficult due to insufficient/decreased amount of fluid in the GI, or happens less often than normal). IBS-C significantly impacts the health and quality of life of affected patients. The cause of IBS-C is unknown, and there are currently no specific diagnostic tests or biomarkers for detection. Therefore, IBS-C is diagnosed by symptoms and by eliminating other disorders. IBS-C is similar to chronic constipation but is clinically distinct as a result of the significant abdominal pain component.



people in the U.S. with IBS-C1


in health-related quality of life and work productivity2


to society, managed care and employers3


due to physician office visits and outpatient services3


“disrupted productivity” due to GI symptoms per month4

1. Lovell 20122. Shin 20153. Doshi 20144. Heidelbaugh, et al 2015