Slide 1: PRO2TECT Top-Line Data
Akebia THERAPEUTICS PRO,TECT TOP-LINE DATA September 3,2020 John P. Butler President and CEO Steven K. Burke, M.D. SVP,R&D and CMO (Nasdaq: AKBA)
Slide 2: Forward-looking statements
Statements in this presentation regarding Akebia’s strategy, plans, prospects, for vadadustat; the potential direct or indirect impact of the COVID-19 pandemic on expectations, beliefs, intentions and goals are forward-looking statements within our business, operations, and the markets and communiti
Slide 3: Our Purpose: To Better the Life of Each Person Impacted by Kidney Disease
Akebia’ THERAPEUTICS OUR PURPOSE To Better the Life of Each Person Impacted by Kidney Disease {a A ) Ve oe oes \Sx . A | — f he yj
Slide 4: Global Phase 3 PRO2TECT Program
Global Phase 3 PRO2TECT Program Studies of Vadadustat for Treatment of Anemia due to Chronic Kidney Disease (CKD) in Adult Patients Not on Dialysis PRO2TECT Consists of Two Randomized, Open-Label, Active-Controlled, Non-Inferiority Phase 3 Cardiovascular Outcomes Studies • Mean change in hemoglobin
Slide 5: Global Phase 3 PRO2TECT Program
Global Phase 3 PRO2TECT 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 labeling) Efficacy Evaluation:
Slide 6: Baseline Demographics
Baseline Demographics PRO2TECT PRO2TECT (Correction) (Conversion) Vadadustat Darbepoetin Alfa Vadadustat Darbepoetin Alfa Characteristic (N=879) (N=872) (N=862) (N=863) Age (yrs), mean (SD) 65.2 (14.3) 64.9 (13.7) 67.3 (13.1) 66.5 (13.5) Proportion male (%) 46.0% 42.0% 45.7% 43.5% BMI (kg/m2), mean
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 PRO2TECT studies, demonstrating non-inferiority to darbepoetin alfa as measured by a mean change in hemoglobin (Hb) between baseline and the primary evaluation p
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 PRO2TECT studies (Correction and Conversion) was performed. PRO2TECT did not meet the primary safety endpoint, defined as non-inferiority of vadadustat vers
Slide 9: Overview of Treatment Emergent Adverse Events (TEAEs)
Overview of Treatment Emergent Adverse Events (TEAEs) PRO2TECT PRO2TECT (Correction) (Conversion) Vadadustat Darbepoetin Alfa Vadadustat Darbepoetin Alfa Category, N (%) Category, N (%) (N=878) (N=870) (N=861) (N=862) Patients with any TEAE 798 (90.9%) 797 (91.6%) Patients with any TEAE 767 (89.1%)
Slide 10: Thank You!
Thank You! We want to extend our sincerest appreciation to our investigators and their staff for participating in the PRO2TECT 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