Akebia Therapeutics, Inc. · NASDAQ:AKBA

Akebia Therapeutics — Technical Presentation (May 2020)

11 slides from Akebia Therapeutics's technical presentation, May 5, 2020

  1. Slide 1: INNO2VATE Top-Line Data

    Akebia’ THERAPEUTIGS INNO,VATE TOP-LINE DATA MAY 5, 2020 John P. Butler President and CEO Steven K. Burke, M.D. SVP and CMO (Nasdaq: AKBA)

  2. Slide 2: Forward-looking statements

    Statements in this presentation regarding Akebia’s strategy, plans, prospects, the results of ongoing or later clinical trials, including PRO2TECT; the risk that expectations, beliefs, intentions and goals are forward-looking statements within clinical trials may not be successful; manufacturing ris

  3. Slide 3: Our Purpose

    Akebia THERAPEUTICS OUR PURPOSE To Better the Life of Each Person Impacted by Kidney Disease

  4. Slide 4: Global Phase 3 INNO2VATE Program

    Global Phase 3 INNO2VATE Program Studies of Vadadustat for Treatment of Anemia due to Chronic Kidney Disease (CKD) in Adult Patients on Dialysis INNO2VATE Consists of Two Randomized, Open‐Label, Active‐Controlled, Non‐Inferiority Phase 3 Cardiovascular Outcomes Studies • Mean change in hemoglobin (H

  5. Slide 5: Global Phase 3 INNO2VATE Program

    Global Phase 3 INNO2VATE Program Hemoglobin (Hb) Target: US: 10‐11 g/dL, Ex‐US: 10‐12 g/dL Vadadustat 300 mg daily (titration to 150‐600 mg daily) Post Treatment Screening 1:1 (End of treatment (≤8 weeks) Darbepoetin Alfa (Intravenous or Sub‐Cutaneous) & Follow‐up) (per labelling) Efficacy Evaluatio

  6. Slide 6: Baseline Demographics

    Baseline Demographics INNO2VATE INNO2VATE (Conversion) (Correction/Conversion) Vadadustat Darbepoetin Alfa Vadadustat Darbepoetin Alfa Characteristic (N=1,777) (N=1,777) (N=181) (N=188) Age (yrs), mean (SD) 57.9 (13.9) 58.4 (13.8) 56.5 (14.8) 55.6 (14.6) Proportion male (%) 55.7% 56.5% 59.1% 60.1% B

  7. Slide 7: Primary and Key Secondary Efficacy Endpoint Results

    Primary and Key Secondary Efficacy Endpoint Results Vadadustat achieved the primary and key secondary efficacy endpoint in each of the two INNO2VATE studies, demonstrating non‐inferiority to darbepoetin alfa as measured by a mean change in hemoglobin (Hb) between baseline and the primary evaluation

  8. Slide 8: Primary Safety Major Adverse Cardiovascular Events (MACE) Endpoint

    Primary Safety Major Adverse Cardiovascular Events (MACE) Endpoint To assess MACE, a combined analysis of time to first MACE event from the two INNO2VATE studies (Conversion and Correction/Conversion) was performed. Vadadustat achieved the primary safety endpoint of the INNO2VATE program, defined as

  9. Slide 9: Kaplan-Meier Curve of Time to Major Adverse Cardiovascular Events (MACE)

    Kaplan‐Meier Curve of Time to Major Adverse Cardiovascular Events (MACE) Adverse Cardiovascular Events (MACE) Probability of Major Hazard Ratio: 0.96 (95% CI: 0.83, 1.11) Stratified Log‐Rank Test P=0.4877

  10. Slide 10: Overview of Treatment Emergent Adverse Events (TEAEs)

    Overview of Treatment Emergent Adverse Events (TEAEs) INNO2VATE INNO2VATE (Conversion) (Correction/Conversion) Vadadustat Darbepoetin Alfa Vadadustat Darbepoetin Alfa Category, N (%) Category, N (%) (N=1,768) (N=1,769) (N=179) (N=186) Patients with any TEAE 1562 (88.3%) 1580 (89.3%) Patients with an

  11. Slide 11: Thank You!

    Thank You! We want to extend our sincerest appreciation to our investigators and their staff for participating in the INNO2VATE program. Most importantly, thank you to our patients who participated in this program. Because of their commitment, we are a step closer to fulfilling our purpose to better

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