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ITEM 1.
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Name and Address of Company
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Aurinia Pharmaceuticals Inc. (the “Company”)
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1203 – 4464 Markham Street
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Victoria, BC V8Z 7X8
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ITEM 2.
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Date of Material Change
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March 1, 2017
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ITEM 3.
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News Release
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A news release relating to the material change described herein was disseminated on March 1, 2017 via Business Wire.
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ITEM 4.
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Summary of Material Change
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The Company announced top-line results from its Phase 2b AURA-LV study in lupus nephritis (“LN”).
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ITEM 5.
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Full Description of Material Change
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The Company announced top-line results from our Phase 2b AURA-LV (AURA) study in LN. At 48 weeks, the trial met the complete and partial remission (“CR”/ “PR”) endpoints, demonstrating statistically significantly greater CR and PR in patients in both low dose (23.7mg of voclosporin twice daily (p<.001)) and high dose (39.5mg twice daily (p=.026)) cohorts versus the control group.
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Each arm of the study included the current standard of care of mycophenolate mofetil as background therapy and a forced steroid taper to 5mg/day by week 8 and 2.5mg by week 16. No unexpected safety signals were observed and there were no additional deaths in the voclosporin treated patients; however, there were three deaths and one malignancy reported in the control arm after completion of the study treatment period.
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The 24 and 48-week top-line efficacy results are summarized below:
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Endpoint
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Treatment
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24 weeks
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Odds ratio
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P-value*
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48 weeks
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Odds Ratio
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P-value*
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23.7mg VCS BID
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33%
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2.03
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p=.045
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49%
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3.21
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p<.001
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Complete
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39.5mg VCS BID
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27%
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1.59
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p=.204
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40%
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2.10
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p=.026
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Remission
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Control Arm
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19%
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NA
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NA
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24%
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NA
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NA
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23.7mg VCS BID
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70%
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2.33
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p=.007
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68%
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2.34
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p=.007
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Partial Remission
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39.5mg VCS BID
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66%
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2.03
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p=.024
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72%
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2.68
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p=.002
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Control Arm
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49%
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NA
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NA
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48%
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NA
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NA
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| *All p-values are vs control | ||||||||||||||
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ITEM 5.2.
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Disclosure of Restructuring Transactions
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Not applicable.
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ITEM 6.
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Reliance on Subsection 7.1(2) of National Instrument 51-102
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Not applicable.
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ITEM 7.
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Omitted Information
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There are no significant facts required to be disclosed herein which have been omitted.
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ITEM 8.
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Executive Officer
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For further information, please contact:
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| Michael R. Martin, Chief Operating Officer | |
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250-415-9713
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| mmartin@auriniapharma.com | |
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ITEM 9.
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Date of Report
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| March 2, 2017 |