Who we do it for

Our patients are at the forefront of everything we do. Our team is passionately committed to bringing medicines that matter to underserved patients with gastrointestinal (GI) and cardiorenal diseases.

OUR CLINICAL TRIALS


GI CLINICAL TRIALS

IBS-C CLINICAL TRIALS

Two ongoing, pivotal Phase 3 clinical trials, T3MPO-1 and T3MPO-2, are being conducted in the U.S. with tenapanor in patients with irritable bowel syndrome with constipation (IBS-C). T3MPO-1 is a 12-week double-blind, placebo-controlled, multi-center, randomized trial with a four-week, placebo-controlled randomized withdrawal period. T3MPO-2 is a six-month, double-blind, placebo-controlled, multi-center, randomized trial. Subjects completing T3MPO-1 and T3MPO-2 are eligible to enroll into T3MPO-3, an open-label, long-term safety study where subjects can continue to receive tenapanor for up to one year. T3MPO-1 and T3MPO-2 will each enroll approximately 600 patients, and the primary endpoint for both trials is the six of 12-week combined overall responder rate compared to placebo. A combined overall responder is defined as a weekly responder to tenapanor for six of 12 weeks where both an abdominal pain response and a complete spontaneous bowel movement (CSBM) response criteria are met during the same week. An abdominal pain responder is defined as a patient with a 30 percent or greater reduction in average weekly worst abdominal pain compared to baseline during the week, and a CSBM responder is defined as a patient who has an increase of one or more on average weekly CSBMs compared to baseline during the week. Clinical data from T3MPO-1 and T3MPO-2 are expected in mid-2017 and by the end of 2017, respectively. T3MPO-3 is also expected to be complete by the end of 2017.

 

For more information on Ardelyx’s clinical trials, please visit:

https://clinicaltrials.gov

CARDIORENAL CLINICAL TRIALS

HYPERPHOSPHATEMIA TRIALS

Tenapanor is being evaluated in an ongoing Phase 3 trial in hyperphosphatemia, or excess levels of phosphorus, in ESRD patients on dialysis. The study is an eight-week, double-blind, randomized trial, with a four-week placebo-controlled randomized withdrawal (RW) period. The primary endpoint is the difference in change between tenapanor and placebo arms from the end of treatment to the end of the RW period in the “responder” patient population. The responder patient population is defined as patients who demonstrate a ≥ 1.2 mg/dL decrease in serum phosphorus from baseline during the initial eight-week treatment period. Clinical data from this trial are expected in the first quarter of 2017. We plan to initiate a second Phase 3 trial of tenapanor in this patient population in the first half of 2017.

HYPERKALEMIA TRIALS

We are evaluating RDX7675 for the treatment of hyperkalemia, or high levels of potassium in the blood, a common condition in patients with chronic kidney disease (CKD), heart failure, and those who are also taking renin-angiotensin-aldosterone system inhibitor (RAASi) medications.

We initiated a Phase 3 clinical trial with RDX7675 for the treatment of hyperkalemia in December 2016. The study will enroll patients with hyperkalemia who are taking RAASi medications. The trial will include three parts: Part A will be a single-blind study in which all subjects receive RDX7675 for four weeks; Part B will be an eight-week, double-blind, placebo-controlled, randomized withdrawal study; and Part C is an open-label, long-term safety study for subjects from Parts A and B. The primary endpoint for Part A is serum potassium change from Part A baseline, and the primary endpoint for Part B is serum potassium change from Part B baseline (RDX7675 versus placebo).

In addition to the Phase 3 trial, we initiated an onset-of-action study in December 2016, designed to evaluate the effect of RDX7675 on the rate of blood potassium lowering, along with safety and efficacy, in approximately 60 patients with hyperkalemia. Data from this trial are expected in the first half of 2017.

For more information on Ardelyx’s clinical trials, please visit:

https://clinicaltrials.gov

IBS-C PATIENTS


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.

IBS-C

~11 MILLION

people in the U.S. with IBS-C

MAJOR REDUCTION

in health-related quality of life and work productivity

ECONOMIC BURDEN

to society, managed care and employers

ADDED PATIENT COSTS

due to physician office visits and outpatient services

~5 DAYS

“disrupted productivity” due to GI symptoms per month

RENAL DIALYSIS PATIENTS


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.

HYPERPHOSPHATEMIA

745,000

ESRD patients with hyperphosphatemia (HP) in major developed countries

~70%

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

19 pills per day

taken by ESRD patients, approximately half of which are phosphate binders

45%

of patients are non-compliant with current treatments

NO TREATMENTS

available that are not phosphate binders

Learn More About Phosphorus and the Importance of Its Management

https://www.kidney.org/atoz/content/phosphorus

CKD/HEART FAILURE PATIENTS


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.

HYPERKALEMIA

~2 MILLION

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

DOSE REDUCTION

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

HK SIDE EFFECT

common with high blood pressure and some anti-diabetic treatments

POOR PALATABILITY

and sodium-ion leads to poor patient compliance

CHRONIC MARKET

emerging, but unaddressed by today’s treatment