European Journal of Heart Failure Publishes Pre-Specified Sub-Group Analysis of Heart Failure Patients With Hyperkalemia From Phase 3 Trial of Patiromer FOS

Relypsa Inc.

, a biopharmaceutical company, today announced that results of a pre-specified sub-group analysis from the Phase 3 OPAL-HK clinical trial of Patiromer for Oral Suspension (Patiromer FOS) were published today in the European Journal of Heart Failure. These data were previously presented in a late breaking clinical trial session at the Heart Failure Society of America Annual Meeting in September 2014. "Patiromer FOS helped people with heart failure and hyperkalemia reduce their blood potassium levels to the normal range and reduced the recurrence of dangerously elevated potassium," said Bert Pitt, M.D., lead author of the European Journal of Heart Failure paper and professor of medicine emeritus in the Department of Internal Medicine at the University of Michigan Medical School. "The findings also showed that heart failure patients could stay on their RAAS medicines while managing their potassium levels with Patiromer FOS. This analysis further supports that, if approved, Patiromer FOS could transform the way hyperkalemia is managed in heart failure patients." The sub-group analysis in hyperkalemic CKD patients with heart failure showed that Patiromer FOS significantly reduced mean blood potassium levels from baseline to week four (p<0.001), and 76 percent of heart failure patients had normal blood potassium levels at four weeks. Patiromer FOS significantly reduced the percentage of heart failure patients with recurrent hyperkalemia compared with placebo over eight weeks (p<0.001). Additionally, 100 percent of heart failure patients on Patiromer FOS were still receiving RAAS inhibitors after eight weeks, versus 55 percent of heart failure patients on placebo. Safety and tolerability of Patiromer FOS was similar between patients with and without heart failure and consistent with that observed in other clinical trials of Patiromer FOS. In the sub-group of heart failure patients, Patiromer FOS was well tolerated and the most common adverse event in these patients was mild-to-moderate constipation (11 percent). The European Journal of Heart Failure publication of the sub-group analysis is available at http://onlinelibrary.wiley.com/doi/10.1002/ejhf.402/full. The main results of the OPAL-HK study were previously published in the New England Journal of Medicine.1 The trial achieved its primary endpoints and Patiromer FOS was well tolerated.