Relypsa announces positive results from Phase 2 clinical trial of RLY5016

Relypsa, Inc., a biopharmaceutical company developing non-absorbed polymeric drugs, today announced positive results from the company's PEARL-HF study, a Phase 2 clinical trial of the company's lead compound, RLY5016. These data were presented by Dr. Bertram Pitt, Professor of Medicine Emeritus, Division of Medicine at the University of Michigan School of Medicine, during the Late-Breaking Clinical Trials Session in an oral presentation titled "The PEARL-HF (Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple-Dose To Evaluate the Effects of RLY5016 in Heart Failure Patients) Trial" at the 14th Annual Scientific Meeting of the Heart Failure Society of America held in San Diego, CA September 13-15, 2010.

“Dr. Pitt's presentations on behalf of the PEARL-HF investigators at HFSA this week and at the European Society of Cardiology meeting in Stockholm in August underscore the potent potassium-lowering effects of RLY5016 and its potential utility for the cardiology and nephrology communities”

PEARL-HF randomized heart failure patients who were already receiving one or more RAAS inhibitors (angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or β-blockers) to 28 days treatment with RLY5016 or placebo. All patients were started on an aldosterone antagonist (spironolactone) on the same day as receiving their first dose of RLY5016. The study met its primary endpoint (mean change from baseline in serum potassium) and multiple secondary endpoints (including reduction of incidence of hyperkalemia and increased dose of spironolactone on RLY5016 versus placebo). In the entire study population, there was also a statistically significant three-fold difference favoring RLY5016 in the proportion of patients developing hyperkalemia compared to placebo. This difference was amplified in patients with chronic kidney disease (eGFR <60 mL/min). Consistent with findings from earlier studies, RLY5016 was safe and well tolerated.

In addition, Relypsa announced that Dr. Mason Freeman, Professor of Medicine, Harvard Medical School, an expert in cardiovascular endocrinology, has joined the company as a strategic clinical advisor for the ongoing development of RLY5016.

"Dr. Pitt's presentations on behalf of the PEARL-HF investigators at HFSA this week and at the European Society of Cardiology meeting in Stockholm in August underscore the potent potassium-lowering effects of RLY5016 and its potential utility for the cardiology and nephrology communities," commented Dr. Freeman. "RLY5016 has demonstrated its potential to manage serum potassium and thereby enable the optimal use of proven RAAS inhibitors in treating diabetic, chronic kidney disease and heart failure patients. I am excited by the data generated to date from this program and am pleased to be involved in helping Relypsa advance RLY5016 to pivotal studies."