Relypsa, inc. private company information – bloomberg hormonal imbalance effects

Relypsa, Inc., a biopharmaceutical company, focuses on the discovery, development, and commercialization of polymeric medicines for patients with conditions that are overlooked and undertreated and can be addressed in the gastrointestinal tract primarily in the United States. The company offers Veltassa (patiromer), a non-absorbed potassium binding polymer for the treatment of hyperkalemia. It has license agreement with Vifor Fresenius Medical Care Renal Pharma Ltd. for developing and commercializing Veltassa outside the United States and Japan. The company was founded in 2007 and is headquartered in Redwood City, California. As of August 31, 2016, Relypsa, Inc. operates as a subsidiary of V…

Relypsa, Inc., a biopharmaceutical company, focuses on the discovery, development, and commercialization of polymeric medicines for patients with conditions that are overlooked and undertreated and can be addressed in the gastrointestinal tract primarily in the United States.


The company offers Veltassa (patiromer), a non-absorbed potassium binding polymer for the treatment of hyperkalemia. It has license agreement with Vifor Fresenius Medical Care Renal Pharma Ltd. for developing and commercializing Veltassa outside the United States and Japan. The company was founded in 2007 and is headquartered in Redwood City, California. As of August 31, 2016, Relypsa, Inc. operates as a subsidiary of Vifor Pharma Ltd.

Relypsa, Inc. 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. 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. 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% of study participants achieved serum K+ levels between 3.8–5.0 mEq/L during the first four weeks (95% of participants were initiated on the 8.4 g/day starting dose). In these studies, the most common adverse events were constipation (6%) and diarrhea (3%). Severe adverse events (hypomagnesemia) were reported in 2% of participants. These events are consistent with the safety profile observed in previous Veltassa clinical trials.

Relypsa, Inc. 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 in a poster session. 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 (p4.8 mg/dL) from baseline to week 4. Decreased PTH levels toward the normal range (pOutcomes 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.