Relypsa Announces Presentation of New Clinical and

REDWOOD CITY, Calif., Nov. 03, 2017 (GLOBE NEWSWIRE) -- Relypsa, Inc., a Vifor Pharma Group company, today announced results from a prespecified analysis of data from the Phase 4 TOURMALINE study of Veltassa® (patiromer) for oral suspension. The purpose of this analysis was to demonstrate the effect of treatment with this non-absorbed potassium binder on key markers of mineral metabolism, including calcium and phosphate. The findings were presented in an oral session at the American Society of Nephrology's (ASN) Kidney Week 2017, taking place October 31-November 5, in New Orleans. Two additional abstracts evaluating treatment with Veltassa in a real-world setting with patients on hemodialysis were presented yesterday in a poster session.

“In the two years since Veltassa was approved for hyperkalemia in the United States, we have seen a tremendous response from patients and physicians indicating that this medicine is having a significant impact on the daily management of their disease,” said Scott Garland, president of Relypsa. “The data presented at ASN Kidney Week provide new insights into Veltassa, which may be of interest to clinicians. The real-world use findings in kidney disease patients on dialysis underscore our continued commitment to studying Veltassa in specific patient populations.”

Effects of the potassium binding polymer patiromer on markers of mineral metabolism (Abstract: FR-OR068)

The Phase 4 TOURMALINE study randomly assigned 114 patients with blood potassium levels greater than 5.0 mEq/L to receive patiromer once-a-day at a starting dose of 8.4 g either with or without food. Patients were treated for four weeks and followed for two weeks after completing patiromer treatment. This prespecified analysis of 112 evaluable patients evaluated key markers of mineral metabolism, including blood levels of parathyroid hormone (PTH), calcium and phosphate, and changes in 24-hour urine calcium and phosphate excretion. The findings, presented by David Bushinsky, M.D., John J. Kuiper Distinguished Professor of Medicine and of Pharmacology and Physiology at the University of Rochester School of Medicine, and chief of the Nephrology Division at the University of Rochester Medical Center, showed treatment with patiromer:

• Resulted in a statistically significant decrease in mean urine phosphate excretion (p<0.01) in all patients and mean blood phosphate (p<0.02) in patients with hyperphosphatemia (>4.8 mg/dL) from baseline to week 4.
• Decreased PTH levels toward the normal range (p<0.0001) from baseline to week 4.
• Did not change mean urine calcium excretion or mean blood calcium levels at week 4.

These findings suggest that when patiromer exchanges intestinal potassium for calcium, some of the released calcium may bind to intestinal phosphate, lowering urine phosphate in all patients and serum phosphate in hyperphosphatemic patients. Additionally, some of the calcium may be absorbed, lowering PTH without changing serum calcium.

Additional Patiromer Data at ASN Kidney Week 2017

Outcomes in end-stage renal disease patients on hemodialysis taking patiromer for hyperkalemia (Abstract: TH-PO779) An analysis of 268 end-stage renal disease patients on hemodialysis who were treated with patiromer at U.S. Fresenius Kidney Care centers assessed real-world outcomes over a six-month period. Patients included in the analysis had a mean of 4.9 years on dialysis. Results showed that patiromer lowered blood potassium levels in a real-world setting. Overall, blood potassium was reduced by 0.5 mEq/L, with the greatest effect occurring among patients with a baseline blood potassium level >6.5 mEq/L.

Patient characteristics and correlates of patiromer initiation for hyperkalemia in hemodialysis (Abstract: TH-PO780) A retrospective analysis of data from a large U.S. dialysis provider evaluated characteristics of 1,379 patients on hemodialysis who began treatment with either patiromer or sodium polystyrene sulfonate (SPS) during a one- year period in typical practice. The results showed that patients in whom patiromer was initiated had higher blood potassium levels and were more likely to have multiple prior hyperkalemia episodes than patients in whom SPS was initiated.

About Hyperkalemia

Approximately 3 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 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 with food. 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  http://www.veltassa.com/pi.pdf .

About Relypsa, Inc.

Relypsa, Inc., a Vifor Pharma Group company, is a biopharmaceutical company focused on the discovery, development and commercialization of polymeric medicines for patients with conditions that are often overlooked and undertreated and can be addressed in the gastrointestinal tract. The Company's first medicine, Veltassa® (patiromer) for oral suspension, was developed based on Relypsa's rich legacy in polymer science. More information is available at www.relypsa.com.

About Vifor Pharma Group

Vifor Pharma Group, formerly Galenica Group, is a global specialty 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 specialty 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. The Vifor Pharma Group, headquartered in Zurich, Switzerland, holds a leading position in all its core business activities. Vifor Pharma Group is listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, security number CH036 067 446 6). For more information, visit www.viforpharma.com.

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