Relypsa Announces Presentation of New Clinical and Real-World Analyses of Veltassa® at ASN Kidney Week 2018

REDWOOD CITY, Calif., Oct. 09, 2018 (GLOBE NEWSWIRE) -- Relypsa, Inc., a Vifor Pharma Group company, will present new data on Veltassa® (patiromer) at the American Society of Nephrology (ASN) Kidney Week, the world’s premier nephrology meeting in San Diego, California, October 23-29. The new data reinforce the company’s commitment to improving the lives of patients with life-threatening conditions such as hyperkalemia–elevated blood potassium levels.

“Relypsa is committed to raising the standard of care for patients with hyperkalemia, many of whom often suffer from other chronic diseases and conditions,” said Patrick Treanor, president (ad interim) of Relypsa. “We look forward to continued collaboration with the kidney community in order to advance our understanding of patiromer.”  

Hyperkalemia is a serious and overlooked condition that occurs when there is a defect in one or more of the mechanisms that maintain the balance of potassium in the body, most commonly because excretion of potassium by the kidneys is decreased. This can be due to acute kidney failure or decreasing kidney function such as in chronic kidney disease (CKD), advancing age, certain medical conditions or medications commonly used in people with cardiovascular and kidney diseases.

While resistant hypertension is common in patients with CKD, patients with reduced kidney function have often been excluded from trials of mineralocorticoid receptor antagonists (MRAs) for the treatment of resistant hypertension due to the risk of hyperkalemia. Relypsa is presenting the detailed methods and design of a study that examines the combination of patiromer and spironolactone (compared to spironolactone alone) in patients with resistant hypertension:

  • Patiromer to Enable Spironolactone Use in the Treatment of Patients with Resistant Hypertension and Chronic Kidney Disease: Rationale and Design of the AMBER Study. Rajiv Agarwal (INFO24; 10:00am-12:00pm PT, Oct 25-27).

Two poster presentations highlight real-world data for treatment of hyperkalemia, reflecting Relypsa’s continued investment in real-world and outcomes research:

  • Electrolyte-Related Events Among United States Veterans with Hyperkalemia. Csaba P. Kovesdy (FR-PO304; 10:00am-12:00pm PT, Oct 26).
  • Patiromer and Maintenance of RAASI Therapy in Hyperkalemic Medicare Patients. Nihar Desai (SA-PO712; 10:00am-12:00pm PT, Oct 27).

Additional studies that further advance the scientific research and understanding of hyperkalemia include:

  • Effects of Patiromer on Markers of Mineral Metabolism in Patients with Hyperkalemia and Hyperphosphatemia. David A. Bushinsky (TH-PO199; 10:00am-12:00pm PT, Oct 25).
  • Efficacy and Safety of Patiromer in Participants with Diabetes: A Pooled Analysis. Patrick Rossignol (FR-PO301; 10:00am-12:00pm PT, Oct 26).
  • Design and Methods of an Open-Label, Multiple Dose Study of Patiromer in Pediatric Patients with CKD and Hyperkalemia (EMERALD). Bradley A. Warady (INFO23; 10:00am-12:00pm PT, Oct 25-27).

In addition to the above posters presented at Kidney Week, Relypsa funded investigator-initiated research, which resulted in the following presentations and posters:

  • Safety and Efficacy of High Dose Spironolactone in Loop Diuretic Resistant Acute Decompensated Heart Failure. Shweta Bansal (SA-OR055; 5:54pm-6:06pm, Oct 27).
  • Course and Outcomes of Hyperkalemia in Hospitalized Patients. Etienne Macedo (FR-PO307; 10:00am-12:00pm PT, Oct 26).
  • Predicting Complicated Hyperkalemia in Hospitalized Patients. Etienne Macedo (FR-PO308; 10:00am-12:00pm PT, Oct 26).

About Hyperkalemia
Approximately three million people in the United States with stage 3 or 4 chronic kidney disease (CKD) and/or heart failure have hyperkalemia, or elevated blood potassium levels. Hyperkalemia can cause abnormal heart rhythms and even sudden death. There are often no warning signs, meaning a person can unknowingly experience spikes in potassium levels recurrently and be at risk for these cardiac events. Some medicines that are often prescribed to people with CKD and heart failure to help delay progression of their underlying disease can cause hyperkalemia as a side effect. These may include renin angiotensin aldosterone system (RAAS) inhibitors such as angiotensin receptor blockers (ARBs), aldosterone antagonists (AAs) and angiotensin-converting-enzyme (ACE) inhibitors.

About Veltassa
Veltassa is a sodium-free potassium binder approved for the treatment of hyperkalemia. Veltassa should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.

Made in powder form consisting of smooth, spherical beads, Veltassa is mixed with water (one-third of a cup) and taken once-a-day. Veltassa is not absorbed and acts within the gastrointestinal tract. It binds to potassium in exchange for calcium, primarily in the colon. The potassium is then excreted from the body through the normal excretion process.

Important Safety Information

Contraindications
Veltassa is contraindicated in patients with a history of a hypersensitivity reaction to Veltassa or any of its components.

Worsening of Gastrointestinal Motility 
Use of Veltassa should be avoided in patients with severe constipation, bowel obstruction or impaction, including abnormal post-operative bowel motility disorders, because Veltassa may be ineffective and may worsen gastrointestinal conditions. Patients with a history of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders were not included in clinical studies.

Hypomagnesemia
Veltassa binds to magnesium in the colon, which can lead to hypomagnesemia. In clinical studies, hypomagnesemia was reported as an adverse reaction in 5.3 percent of patients treated with Veltassa. Approximately 9 percent of patients in clinical trials developed hypomagnesemia with a serum magnesium value <1.4 mg/dL. Doctors should monitor serum magnesium and consider magnesium supplementation in patients who develop low serum magnesium levels.

Adverse Reactions
The most common adverse reactions (incidence ≥2 percent) are constipation, hypomagnesemia, diarrhea, nausea, abdominal discomfort and flatulence. Mild to moderate hypersensitivity reactions were reported in 0.3 percent of patients treated with Veltassa and included edema of the lips.

For Veltassa’s full Prescribing Information, please visit https://www.veltassa.com/pi.pdf.

About Relypsa, Inc.
Relypsa, Inc., a Vifor Pharma Group company, is a biopharmaceutical company focused on the development and commercialization of late-stage medicines in the iron deficiency, nephrology and cardio-renal therapeutic areas. Relypsa is committed to delivering innovative therapies and improving the lives of patients with serious and life-threatening conditions that are often overlooked and undertreated. The Company's first medicine, Veltassa® (patiromer) for oral suspension, was approved by the U.S. FDA in October 2015, making it the first approved medicine for the treatment of hyperkalemia in more than 50 years. More information is available at www.relypsa.com.

About Vifor Pharma Group
Vifor Pharma Group, formerly Galenica Group, is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is the partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, a joint company with Fresenius Medical Care; Relypsa; and OM Pharma. Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348). For more information, please visit www.viforpharma.com.

Contact:
Albert Liao
Director of U.S. Communications
Relypsa
+1 650 421 9532
media@relypsa.com

Ads