EX-99.1 2 a51519639ex99_1.htm EXHIBIT 99.1
Exhibit 99.1
 
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
 
 
 
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.
 
 
ITEM 8.
Executive Officer
 
 
 
For further information, please contact:
   
  Michael R. Martin, Chief Operating Officer
 
250-415-9713 
  mmartin@auriniapharma.com 
   
ITEM 9.
Date of Report
   
  March 2, 2017 
 
 
 
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