REDWOOD CITY, Calif., April 11, 2018 (GLOBE NEWSWIRE) -- Relypsa, Inc., a Vifor Pharma Group company, today announced results from a pooled analysis of three clinical trials evaluating the effects of Veltassa® (patiromer) for lowering serum potassium (K+) levels in patients with hyperkalemia. The findings of the analysis will be presented in a poster session at the National Kidney Foundation’s (NKF) 2018 Spring Clinical Meetings (SCM18), taking place April 10-14, in Austin, Texas.
Hyperkalemia (elevated blood potassium levels) is a serious condition that may arise as a side effect of medicines prescribed to people with chronic kidney disease (CKD), such as renin angiotensin aldosterone system (RAAS) inhibitor therapy.
“Controlling potassium levels is an important treatment goal for people living with CKD and other chronic conditions,” said Scott Garland, president of Relypsa. “These new data suggest that Veltassa consistently lowers potassium levels and further highlights its clinical significance in people with hyperkalemia, including patients who are on RAAS inhibitor therapy.”
A pooled analysis of 653 participants from the OPAL-HK, AMETHYST-DN and TOURMALINE Phase 3 clinical studies showed Veltassa lowered serum K+ consistently in all three clinical trials for the treatment of hyperkalemia, regardless of severity. Efficacy data were also presented for a subgroup of study participants who initiated patiromer at 8.4 g/day. Results showed that 96 percent of study participants achieved serum K+ levels between 3.8–5.0 mEq/L during the first four weeks (95 percent of participants were initiated on the 8.4 g/day starting dose). In these studies, the most common adverse events were constipation (6 percent) and diarrhea (3 percent). Severe adverse events (hypomagnesemia) were reported in 2 percent of participants. These events are consistent with the safety profile observed in previous Veltassa clinical trials.
Poster 266: Consistency of Serum Potassium Effects in Patiromer Clinical Trials
Overall, a total of 653 participants were evaluated for efficacy and safety in this pooled analysis that included patients with hyperkalemia from the OPAL-HK, AMETHYST-DN and TOURMALINE clinical studies. Study participants who took at least one dose of patiromer and had at least one post-baseline serum K+ measurement were included in the analysis. Mean serum K+ results over the first 4 weeks were pooled across all three studies. Efficacy data were also presented for a subgroup of study participants who initiated patiromer at 8.4 g/day (the recommended starting dose in the United States and European Medicines Agency prescribing information). Safety in the first four weeks was assessed by reports of adverse events and laboratory abnormalities and was reported for study participants pooled across all three studies. The majority of study participants (98 percent) had hypertension, and 93 percent of participants were taking RAAS inhibitor therapy.
About Hyperkalemia
Approximately 3 million people in the U.S. 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 colonic 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 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 pharmaceutical 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