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ZS-9 Mechanism of Action
Sodium Zirconium Cyclosilicate: Update from ZS-9 HARMONIZE Trial Bruce Spinowitz, M.D. FACP Associate Director, Nephrology Vice Chairman, Medicine New York Hospital Queens Clinical Professor of Medicine Cornell University Medical Center Background ZS-9 Mechanism of Action ZS004 HARMONIZE Current Treatment Options for Hyperkalemia are Limited Kosiborod, M et al. JAMA 2014, presented at AHA 2014 Non-Specific Polymer Resin Action in GI Tract Stravos et al. PlosONE 2014 Background ZS-9 Mechanism of Action ZS004 HARMONIZE ZS-9 :Novel, First-in-Class, Inorganic Crystalline Compound Designed Specifically to Trap Potassium Stravos et al. PLOS ONE 2014 ZS-9 Action in GI Tract Stravos et al. PLOS ONE 2014 ZS-9 is More Selective for Potassium than SPS Stravos et al. PLOS ONE 2014 Packham, D. et al. N Engl J Med 2014; Kosiborod, M. et al. JAMA 2014 Background ZS-9 Mechanism of Action ZS004 HARMONIZE Clinical Trial Design Efficacy Safety Conclusions ZS004 Second Phase 3 Study Design Kosiborod, M et al. JAMA 2014 Kosiborod, M et al. JAMA 2014 Study Endpoints Kosiborod, M et al. JAMA 2014 Study Population Kosiborod, M et al. JAMA 2014 Baseline Characteristics Kosiborod, M et al. JAMA 2014 Background ZS-9 Mechanism of Action ZS004 HARMONIZE Clinical Trial Design Efficacy Safety Conclusions ZS004 Highlights Kosiborod, M et al. JAMA 2014 HARMONIZE Trial Results: Open-Label Phase Kosiborod, M et al. JAMA 2014 HARMONIZE Trial Open Label Phase: Consistent Efficacy in All Subgroups Kosiborod, M et al. JAMA 2014 HARMONIZE Trial Achieves Primary Endpoint, Mean K+ Maintenance on Days 8-29 for All Doses Kosiborod, M et al. JAMA 2014 HARMONIZE Trial Randomized Phase: Mean Potassium Levels Over Time Kosiborod, M et al. JAMA 2014 HARMONIZE Trial Randomized Phase: Proportion of Patients with Mean K <5.1 mEq/L during Days 8-29 Kosiborod, M et al. JAMA 2014 Randomized Phase: Efficacy Consistent in All Subgroups Kosiborod, M et al. JAMA 2014 Background ZS-9 Mechanism of Action ZSOO4 HARMONIZE Clinical Trial Design Efficacy Safety Conclusions HARMONIZE Trial Safety and Tolerability Kosiborod, M. et al. JAMA 2014 Safety Information (2 of 2) Kosiborod, M. et al. JAMA 2014 Consistent Profile of Other Safety Data of Interest Throughout ZS-9 Clinical Program Kosiborod, M. et al. JAMA 2014 Background ZS-9 Mechanism of Action ZS004 HARMONIZE Conclusion Conclusions Kosiborod, M. et al. ZS Pharma R&D Analyst Day, NYC, 2014