Update from ZS-9 HARMONIZE Trial - .Sodium Zirconium Cyclosilicate: Update from ZS-9 HARMONIZE Trial

  • View
    217

  • Download
    3

Embed Size (px)

Text of Update from ZS-9 HARMONIZE Trial - .Sodium Zirconium Cyclosilicate: Update from ZS-9 HARMONIZE Trial

  • 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

  • Stravos et al. PlosONE 2014

    Non-Specific Polymer Resin Action in GI Tract

  • 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

  • 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