Slide 1: Clinical Program Update AURORA 2 / voclosporin
CLINICAL PROGRAM UPDATE AURORA 2 / voclosporin Updated January 2022
Slide 2: AURORA 2 Readout Results
AURORA 2 demonstrated a favorable risk/benefit profile over a three-year period, with safety comparable to AURORA 1, and sustained efficacy AURORA 2 Readout Results
Slide 3: AURORA 2 Study Design
AURORA 2 Study Design AURORA 1 (n=357) One-Year Study AURORA 2 (n=216) Two-Year Study • AURORA 2 is a Phase 3, global, double-blind, two-year continuation study of AURORA 1 evaluating voclosporin compared to placebo, in combination with MMF and low-dose steroids, in subjects with lupus nephritis • T
Slide 4: AURORA 2 Demographics
Placebo n=% (n=100) Voclosporin n=% (n=116) Age, years Mean (SD) 11.64 (35.4) 10.31 (32.3) Sex, n (%) Female 88.0 (88) 90.5 (105) Male 12.0 (12) 9.5 (11) Race, n (%) White 40.0 (40) 37.9 (44) Asian 30.0 (30) 25.9 (30) Black 7.0 (7) 15.5 (18) Other 23.0 (23) 20.7 (24) Biopsy class, n (%) Pure Class I
Slide 5: AURORA 2 Clinical Characteristics
Placebo n=100 Voclosporin n=116 Corrected* eGFR, mL/min/1.73 m2, mean (SD) AURORA 1 Baseline 78.7 (16.58) 79.0 (15.05) AURORA 2 Baseline (Month 12) 83.3 (12.61) 80.7 (13.53) UPCR, mg/mg, mean (SD) AURORA 1 Baseline 3.868 (2.4764) 3.941 (2.5766) AURORA 2 Baseline (Month 12) 1.47 (1.640) 0.86 (1.363)
Slide 6: eGFR (Mean) Over Time
Corrected eGFR (mL/min/1.73m², mean) Over Time Baseline Month 3 Month 6 Month 9 Month 12 Month 15 Month 18 Month 21 Month 24 Month 27 Month 30 Month 33 Month 36 60 70 80 90 100 eG FR (m L/ m in /1 .7 3m ²) eGFR (Mean) Over Time AURORA 01 AURORA 02 4-week follow up 100 100 100 100 100 98 96 90 81 84
Slide 7: Mean UPCR (LSMean) by Visit
Mean UPCR by visit Baseline Month 3 Month 6 Month 9 Month 12 Month 15 Month 18 Month 21 Month 24 Month 27 Month 30 Month 33 Month 36 FUP 0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 5 U PC R (m g/ m g) Mean UPCR (LSMean) (mg/mg) by Visit 100 100 100 100 100 96 96 90 81 86 87 84 87 85 116 111 116 116 116 113 113 10
Slide 8: Summary of AURORA 2 Adverse Events
Summary of AURORA 2 Adverse Events Placebo (N = 100) Voclosporin (N = 116) % (n) % (n) Any AE 80.0 (80) 86.2 (100) Treatment-Related AE 21.0 (21) 24.1 (28) Serious AE 23.0 (23) 18.1 (21) Treatment-Related Serious AE 2.0 (2) 0.9 (1) AE Leading to voclosporin/Placebo Discontinuation 17.0 (17) 9.5 (11)
Slide 9: AURORA 2 Readout Results
AURORA 2 demonstrated a favorable risk/benefit profile over a three-year period, with safety comparable to AURORA 1, and sustained efficacy AURORA 2 Readout Results
Slide 10: Thank you
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