FORM 51-102F3 MATERIAL CHANGE REPORT ITEM 1. Name and Address of Company Aurinia Pharmaceuticals Inc. (the " Company ") 1203 - 4464 Markham Street Victoria, BC V8Z 7X8 ITEM 2. Date of Material Change
Wednesday, March 1, 2017 1 min read
Key Takeaway: MATERIAL CHANGE REPORT
ITEM 1. Name and Address of Company Aurinia Pharmaceuticals Inc. (the " Company ") 1203 - 4464 Markham Street Victoria, BC V8Z 7X8 ITEM 2. Date of Material Change March 1, 2017 ITEM 3. News Release A news release relating to the material change descri
Full Press Release Details
MATERIAL CHANGE REPORT
ITEM 1.
Name and Address of Company
Aurinia Pharmaceuticals Inc. (the " Company ")
1203 - 4464 Markham Street
Victoria, BC V8Z 7X8
ITEM 2.
Date of Material Change
March 1, 2017
ITEM 3.
News Release
A news release relating to the material change described herein was disseminated on March 1, 2017 via Business Wire.
ITEM 4.
Summary of Material Change
The Company announced top-line results from its Phase 2b AURA-LV study in lupus nephritis (" LN ").
ITEM 5.
Full Description of Material Change
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.
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.
The 24 and 48-week top-line efficacy results are summarized below:
Endpoint
Treatment
24 weeks
Odds ratio
P-value*
48 weeks
Odds Ratio
P-value*
23.7mg VCS BID
33%
2.03
p=.045
49%
3.21
p<.001
Complete
39.5mg VCS BID
27%
1.59
p=.204
40%
2.10
p=.026
Remission
Control Arm
19%
NA
NA
24%
NA
NA
23.7mg VCS BID
70%
2.33
p=.007
68%
2.34
p=.007
Partial Remission
39.5mg VCS BID
66%
2.03
p=.024
72%
2.68
p=.002
Control Arm
49%
NA
NA
48%
NA
NA
*All p-values are vs control
ITEM 5.2.
Disclosure of Restructuring Transactions
Not applicable.
ITEM 6.
Reliance on Subsection 7.1(2) of National Instrument 51-102
Not applicable.
ITEM 7.
Omitted Information
There are no significant facts required to be disclosed herein which have been omitted.