Relypsa Announces Presentation of Positive Phase 2 Results for RLY5016 at American Society of Hypertension Meeting
RLY5016 dose titration maintains normal serum potassium levels in patients with heart failure and chronic kidney disease
SANTA CLARA, Calif.--(BUSINESS WIRE)--May 23, 2011 - Relypsa, Inc. today announced the presentation of positive results from a Phase 2 clinical trial of the company's lead compound, RLY5016, a non-absorbed oral potassium binder being developed as a treatment for hyperkalemia (elevated serum potassium levels). These data were presented in a poster titled “A Multicenter, Open-Label, Single-Arm Study to Evaluate a Titration Regimen for the Potassium Binding Polymer RLY5016 in Patients with Heart Failure and Chronic Kidney Disease” (Poster PO-127) at the American Society of Hypertension Annual Meeting in New York.
The results showed that in 63 patients with chronic kidney disease (with a mean estimated glomerular filtration rate of 46 mL/min/1.73m2) and heart failure on standard renin-angiotensin-aldosterone-system (RAAS) blocker therapy, RLY5016 dose titration successfully allowed treatment with the maximum labeled dose of the aldosterone antagonist spironolactone while maintaining normal serum potassium levels. After eight weeks of treatment, 57 patients (90%) had serum potassium levels in the normal range, and in over half of the patients, no more than one dose titration was required to achieve and maintain a normal serum potassium level. Among patients with diabetes and albuminuria, both blood pressure and albumin:creatinine ratio were significantly reduced, suggesting that RLY5016 may enable beneficial treatment with RAAS inhibitors in these high risk patients. RLY5016 was well tolerated in the study with mild to moderate gastrointestinal side effects noted in only 10 patients (16%).
“After clearly demonstrating the potassium-lowering effects of RLY5016 versus placebo in earlier studies, we were very pleased to see that patients with moderate to severe kidney disease could be effectively kept in a safe serum potassium range through few dose titrations, most of which occurred early in the study,” said I-Zu Huang, M.D., Vice President of Clinical Development. Relypsa's President, Gerrit Klaerner, Ph.D., noted, “The opportunity to present our latest trial results at such an important meeting, underscores the medical community's continued interest in RLY5016. I am proud of our clinical team executing another study in record time and delivering more compelling evidence that many patients with chronic kidney disease, who are facing high mortality risk and progression to dialysis, do not receive appropriate RAAS inhibitor treatment due to hyperkalemia.”
About RLY5016 and Hyperkalemia
Hyperkalemia is a condition frequently prevalent in patients that suffer from renal impairment, hypertension, diabetes and heart failure. It is characterized by elevated serum potassium levels, which can lead to cardiac arrhythmia and sudden death. Patients with chronic kidney disease are at particular risk for developing hyperkalemia, especially those treated with renin-angiotensin-aldosterone-system (RAAS) inhibitors. Although RAAS inhibition in such patients has been shown to prolong kidney function, many are untreated or undertreated due to the undesirable side effect of increasing serum potassium.
RLY5016 is a high capacity non-absorbed oral potassium binder being developed for the management of elevated serum potassium levels. Relypsa has completed several clinical trials of RLY5016 that have demonstrated the preliminary efficacy, safety and tolerability of RLY5016 for the prevention of hyperkalemia.
About Relypsa, Inc.
Relypsa, Inc. is a clinical-stage biopharmaceutical company leading the discovery and development of novel non-absorbed polymeric drugs for important applications in cardiovascular and renal diseases. Relypsa's lead product candidate is RLY5016, a non-absorbed potassium binder for the treatment of hyperkalemia. Relypsa is pursuing the discovery of additional product candidates through use of its proprietary polymer platform. Privately-held, Relypsa's investors include: OrbiMed Advisors, 5AM Ventures, Delphi Ventures, New Leaf Venture Partners, Sprout Group, Amgen and Mediphase Venture Partners. More information is available at www.relypsa.com.
Contact: Relypsa, Inc.
Jim Johnson, CFO, SVP, 408-200-9500
Posted: May 2011