national kidney foundation spring clinical meeting · 4/29/2017 · national kidney foundation...

Investor Event

April 20, 2017

National Kidney FoundationSpring Clinical Meeting

www.auriniapharma.com

Forward Looking Statements

2

Certain of the statements made in this presentation may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-

looking statements within the meaning of applicable U.S. securities law. These forward-looking statements or information include, but are not limited to statements or

information with respect to the projected worth of the lupus nephritis (LN) market, that voclosporin is potentially a best-in-class calcineurin-inhibitor (CNI) with robust

intellectual property exclusivity and the likelihood of data exclusivity in major markets, the expectation that voclosporin will be the only CNI with a label for LN, the

expected progress of the AURION study; the anticipated commercial potential of voclosporin for the treatment of LN; and anticipated interactions with the US Food and

Drug Administration. When used in these marketing materials, the words “anticipate”, “will”, “believe”, “estimate”, “expect”, “intend”, “target”, “plan”, “goals”,

“objectives”, “may” and other similar words and expressions, identify forward-looking statements or information.

We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the

market value for the LN program; that another company will not create a substantial competitive product for Aurinia’s LN business without violating Aurinia’s

intellectual property rights; and the size of the LN market. Even though the management of Aurinia believes that the assumptions made and the expectations

represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the

actual results, performance or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such

forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary

materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following: the

market for the LN business may not be as estimated; and competitors may arise with similar products.

Although we have attempted to identify factors that would cause actual actions, events or results to differ materially from those described in forward-looking

statements and information, there may be other factors that cause actual results, performances, achievements or events to not be as anticipated, estimated or

intended. Also many of the factors are beyond our control. There can be no assurance that forward-looking statements or information will prove to be accurate, as

actual results and future events could differ materially from those anticipated in such statements. Accordingly you should not place undue reliance on forward-looking

statements or information.

Except as required by law, Aurinia will not update forward-looking information. All forward-looking information contained in this presentation is qualified by this

cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business can be found in

Aurinia’s most recent Annual Information Form available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval

(SEDAR) website at www.sedar.com or the U.S. Securities and Exchange Commission’s Electronic Document Gathering and Retrieval System (EDGAR) website at

www.sec.gov/edgar.


Guest Speakers & Disclosures

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Samir Parikh, MD: Assistant Professor of Clinical Nephrology at the Ohio State University; Fellow of American Society of Nephrology (ASN)Research grant, Clinical Investigator

Michael Bubb, MD: Associate Professor of Medicine, Rheumatology and Clinical Immunology at the University of FloridaConsultant for Aurinia

Gabrielle Davis: Former News Journalist turned Patient AdvocateConsultant for Aurinia


Agenda

4

Welcome Celia Economides, Head of IR, Aurinia

Living with LN Gabrielle Davis, Patient Advocate

Overview of Voclosporin Robert Huizinga, VP, Clinical Affairs, Aurinia

AURA 48-week Results Samir Parikh, MD, Assistant Professor of Clinical Nephrology, the Ohio State University

Panel Discussion/Q&A Moderator: Simrat Randhawa, Head of Medical Affairs, AuriniaRichard Glickman, CEO, AuriniaGabrielle Davis, Patient AdvocateMichael Bubb, MD, Associate Professor of Medicine, Rheumatology & Clinical Immunology, University of FloridaSamir Parikh. MD, Assistant Professor of Clinical Nephrology, the Ohio State University

Closing Remarks Richard Glickman, CEO, Aurinia


Overview of Voclosporin

Robert Huizinga, Vice President, Clinical Affairs, Aurinia

5


Voclosporin: A Novel Calcineurin Inhibitor Providing Significant Clinical Differentiation

Voclosporin has a modified functional group on amino acid 1 which allows the molecule to offer several advantages over legacy CNI’s

*Legacy CNI’s (cyclosporine & tacrolimus) are not approved for Lupus Nephritis in the EU/US

Altered functional group on CsA

Voclosporin

Impacts binding to the latch region on

calcineurinModification results in:

1) Predictable PK/PD relationship

2) Increased potency 3-4 fold (vs. CSA)

3) Altered metabolic profile and faster elimination of resultant metabolites

Clinical benefits*:

• Allows for flat dosing • Improved lipid profile (vs. CSA)

• Reduced risk of diabetes (vs. TAC)

• No impact on MPA levels when used in combination (vs. CsA)

N

HO

O

HN

N

OO

N

O

N

O

N O

NH

O

HN

O

N

O

HN

O

N

O

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Binding to Calcineurin Occurs Through the Latch Region of Voclosporin

Calcineurin

Voclosporin

Latch region

Kuglstatter A, et al. Acta Crystallogr D Biol Crystallogr. 2011;67(Pt 2):119-123.


Synergistic Impact of Calcineurin Inhibition in LN

APC, antigen-presenting cell; IL, interleukin; INF, interferon; LN, lupus nephritis; NFAT, nuclear factor of activated T-cells; TNF, tumor necrosis factor.1. Mak A, Kow NY. J Immunol Res. 2014;2014:419029. doi:10.1155/2014/419029.2. Cooper JE, et al. Clin Nephrol. 2010;73(5):333-343.3. Zhang B, Shi W. Int J Nephrol. 2012;2012:809456. 4. Wang Y, et al. J Am Soc Nephrol. 2010;21(10):1657-1666.5. Faul C. et al. Nat Med. 2008;14(9):931-938.

Voclosporin has a synergistic and dual mechanism of action that has the potential to improve near- and long-term outcomes in LN when added to SoC (MMF)

By inhibiting calcineurin, voclosporin blocks IL-2 expression and T cell–mediated immune responses1,2

CNI’s have shown an ability to stabilize podocytes in the kidney, which protects

against podocytopathy and proteinuria3-5

Cytoplasm

T cell

receptor

APC

Nucleus

IL-2

INF-gamma

TNF-alphaCell-mediated

immune

response

Voclosporin

Voclosporin

Actin

cytoskeleton Dephosphorylated

synaptopodin

breaks up and

destabilizes the

actin cytoskeleton

of the podocyte

Glomerular basement membrane

Synaptopodin

Stabilization of the actin cytoskeleton within the podocyte via calcineurin inhibition has the potential to be disease

modifying in LN

Tissue

damage

8


Voclosporin - Key Benefits 1,2,3

1. Aurinia Data on file2. Busque S, et al. Am J Transplant. 2011;11(12):2675-2684 & AURA LV Data

3. AURA-LV Data on file

Voclosporin

Increased Potency vs. cyclosporine A,

allowing lower dosing

requirements 1

Limited inter & intra patient variability –

allowing flat dosing 1,3

Limited incidence of glucose intolerance

& diabetes at targeted doses vs.

tacrolimus 2

Less cholesterolemia than cyclosporine A 1

0 2 4 6 80

100

200

300

400

500

600

Time (h)

Co

nce

ntr

atio

n (

ng/

mL)

VCSCsA

4.5

5.0

5.5

6.0

6.5

–10 0 10 20 30 40 50 60 70 80

Week

Drug therapy ends

Total Cholesterol (Study Isa05-25)Mean ±95% CI

VCS

CsA

0

5

10

15

20

Cas

es o

f n

ew o

nse

t d

iab

etes

(12

mo

nth

s)

Low conc. Mid conc.Voclosporin Tacrolimus

Mea

n t

ota

l ch

ole

ster

ol

9

Concentration (ng/mL)

0 10 20 30 40 50 600

10

20

30

40

50

60

70

80

90

100

r = 0.5

%C

NI

Concentration (ng/mL)0 250 500 750 1,000 1,250 1,500

0

25

50

75

100

%C

NI

r = 0.7

Concentration (ng/mL)

0 100 200 300 400 500 600 700 800 900

0

25

50

75

100

r = 0.8

%C

NI


AURA-LV (AURA) 48-week data in Lupus Nephritis

Samir Parikh, MD, the Ohio State University

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SLE & LN Overview & Symptomatology

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1. Lupus Foundation of America website: http://www.lupus.org/about/statistics-on-lupus

2. NIDDK, Lupus Nephritis. https://www.niddk.nih.gov/health-information/health-topics/kidney-disease/lupus-nephritis/Pages/index.aspx. Accessed July 26, 2016.

3. Maroz N, Segal MS. Am J Med Sci. 2013;346(4):319-23. 4. Lupus Foundation of America, http://www.lupus.org/resources/15-questions-

kidney-issues-and-lupus1. Accessed July 26, 2016.

CENTRAL NERVOUS SYSTEM

Headaches, dizziness, memory disturbances,

vision problems, seizures, stroke,

or changes in behavior

LUNGS

Pleuritis, inflammation, or pneumonia

BLOOD

Anemia, decreased white cells, increased risk of

blood clots

HEART

Chest pains, heart murmurs

KIDNEYS

Inflammation

SLE is a chronic, complex and often disabling autoimmune disorder

Affects over 500K people in the US (mostly women)1

Highly heterogeneous, affecting range of organ &

tissue systems1

LN is an inflammation of the kidneys caused by SLE & represents a serious progression of SLE

Up to 60% of SLE patients develop LN2

Straightforward disease outcomes—early response correlates w/long term outcomes; measured by proteinuria2

Debilitating and costly, often leading to ESRD, dialysis, renal transplant, and death2

Severe LN progresses to ESRD within 15 years of diagnosis in 10% to 30% of patients3

Leakage of blood proteins into the urine (proteinuria) is clinical sign of LN4

NO FDA OR EMA APPROVED LN THERAPIES

Widespread

fatigue, fever, joint pain, muscle aches,

photosensitivity, rashes, hair loss, oral ulcers, anxiety & depression

!

http://www.lupus.org/about/statistics-on-lupus

https://www.niddk.nih.gov/health-information/health-topics/kidney-disease/lupus-nephritis/Pages/index.aspx

http://www.lupus.org/resources/15-questions-kidney-issues-and-lupus1


The Severity of Lupus Nephritis

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Mok et al, Arthritis Rheum 2013

Standardized

mortality ratio

SLE patients w/renal damage and ESRD have 14-fold and >60-fold increased risk, of premature death, respectively

12


Early Clinical Response is Critical to Maintaining Long-Term Kidney Health in LN

13

8%

57%

87%

0%

20%

40%

60%

80%

100%

120%

Complete Remission Partial Remission No Response

LN patient survival without ESRD based on treatment response1

Not on Dialysis @ 10 years On Dialysis at 10 years

92%

43%

13%

1. Chen YE, et al. Clin J Am Soc Nephrol. 2008;3(1):46-53. Response = 50% reduction in proteinuria; Remission = proteinuria <.33 g/24 hrs..

% o

f P

atie

nts

Rapid control & reduction of proteinuria in lupus patients may show a reduction in the need for dialysis1


STANDARD THERAPY for PROLIFERATIVE LN

IV Cyclophosphamide 0.5-1g/m2 Monthly for 6 months

Proliferative LN: Give IV Methylprednisolone 0.5-1g/d for 1-3 days followed byOral Prednisone 1mg/kg/d ideal body weight, Maximum 80 mg/d, Taper Over Weeks

PLUS:

Oral MMF 2-3g/d for 6 months

PO Cyclophosphamide 1-1.5mg/kg/d, maximum 150 mg/d for 2-4 months

IV Cyclophosphamide 500 mg every 2 weeks for 3 months: LOW-DOSE-EURO-LUPUS REGIMEN

Or OrOr

24 week Partial Response & Complete Remission

Rates with Cyclophosphamide and MMF2

0%

10%

20%

30%

40%

50%

60%

Partial Response Complete Remission

Cyclophosphamide MMF

9%

53%56%

% o

f P

atie

nts

8%

*

Results of the Aspreva Lupus Management Study (ALMS) showed that the majority of patients failed to achieve CR at 24 weeks for both of these first-line therapeutics2

A better solution is needed to improve renal response rates for LN

1. Hahn BH, et al. Arthritis Care Res (Hoboken). 2012;64(6):797-808.2. Appel GB, et al. J Am Soc Nephrol. 2009;20(5):1103-1112


Drug Class Target Clinical Trial Status

Abatacept-BMS CTLA4-Ig CTLA4-B7 Phase 3- FAILED

Abatacept-ACCESS CTLA4-Ig CTLA4-B7 Phase 2- FAILED

Laquinamod Small Molecule Inflammation Phase 2- ENCOURAGING

Rituximab Monoclonal Antibody CD20 Phase 3- FAILED

Ocrelizumab Monoclonal Antibody CD20 Phase 3 - STOPPED

Sirukumab Monoclonal Antibody IL-6 Phase 2-FAILED

Bortezomib Proteasome Inhibitor Plasma Cells Phase 4- STOPPED

Anti-CD40 Ligand Monoclonal Antibody CD40 Ligand Phase 2- STOPPED

Tabalumab Monoclonal Antibody BLyS Phase 3- FAILED

Anti-TWEAK Monoclonal Antibody TWEAK Phase 2- FAILED

Recently Completed Clinical Trials in LN

Parikh et al JASN 2016


CNIs as Part of a Multi-Target Initial Treatment Regimen

Liu et al, Ann Int Med, 2015

LN IV MP 500mg/d X3d Oral Steroid Taper 0.6mg/kg/d

IV Pulse CYC 0.75g/m2MMF 1g/d+TAC 4mg/d

Complete Renal Remission

N=368

P < 0.001


AURA Study Design: Phase IIB

17

Study was designed to evaluate whether voclosporin added to SoCcan increase speed of remission & overall remission rates

in the presence of extremely low steroids

VOCLOSPORIN 23.7 mg bid VOCLOSPORIN 23.7 mg bid

MMF 2 g + oral corticosteroids

VOCLOSPORIN 39.5 mg bid VOCLOSPORIN 39.5 mg bid


PLACEBO PLACEBO


Secondary endpoint

48 weeks

Primary endpoint

24 weeks

1:1

Ran

do

miz

ati

on

N=

26

5

20-25 mg/daily

15-20 mg/daily

10-15 mg/daily

5 mg/daily

2.5 mg/daily

Week 2 4 6 12 24 48

AURA - forced steroid taper

8


AURA Key Inclusion Criteria & Outcome Measures

Indicative of highly active disease

KEY INCLUSION CRITERIA

Diagnosis of SLE according to ACR criteria

Biopsy proven LN [Class III, IV or Class V (alone or in combination w/Class III or

IV)]

Proteinuria of ≥1.5 mg/mgOR ≥2 mg/mg*

PRIMARY OUTCOME MEASURES

CR is defined as: Confirmed urinary protein/creatinine ratio of ≤0.5 mg/mg

Normal, stable renal function (≥60 mL/min/1.73m2 or no confirmed decrease from baseline in eGFR of ≥20%)

The proportion of subjects achieving complete remission (CR) at 24 weeks

KEY SECONDARY OUTCOMES

Partial Remission, Time to Remission, Time to Partial Remission, Durability of remission and extra-renal activity (SLEDAI) at 24 & 48 weeks

+

*≥2 mg/mg refers to Class V patients

Presence of sustained, low dose steroids (≤10mg prednisone from week 16-24)

No administration of rescue medications

18


AURA: Baseline Demographics

1919

Baseline Demographics ControlN=88

VCS 23.7mg BIDN=89

VCS 39.5mg BIDN=88

TotalN=265

Age (years) n 88 89 88 265

Mean ± SD 33.1 ± 10.0 31.4 ± 11.8 30.6 ± 9.6 31.7 ±10.5

Sex n (%)

Female 73 (83.0) 76 (85.4) 81 (92.0) 230 (86.8)

Race n (%)

White 42 (47.7) 30 (33.7) 36 (40.9) 108 (40.8)

Black 5 (5.7) 3 (3.4) 6 (6.8) 14 (5.3)

Asian (Indian sub-continent)

18 (20.5) 22 (24.7) 20 (22.7) 60 (22.6)

Asian (Other) 18 (20.5) 30 (33.7) 24 (27.3) 72 (27.2)

Other 5 (5.7) 4 (4.5) 2 (2.3) 11 (4.2)

Hispanic n (%)

Hispanic or Latino 13 (14.8) 9 (10.1) 13 (14.8) 35 (13.2)

Not Hispanic or Latino 75 (85.2) 80 (89.9) 75 (85.2) 230 (86.8)


Baseline Clinical Characteristics ControlN = 88

VCS 23.7 mg BIDN=89

VCS 39.5 mg BIDN=88

TotalN = 265

Biopsy Class n (%)

Pure Class V 13 (15.0) 12 (13.5) 14 (15.9) 39 (14.7)

Non Class V (Class III, IV) 75 (85.0) 77 (86.5) 74 (84.1) 226 (85.3)

Baseline eGFR CKD-EPI (mL/min/1.73m²)

Mean ± SD 100 ±26.9 95 ±28.4 105 ±27.5 100 ± 27.8

Median 100 95 109 101

Min/Max 49, 153 41, 148 42, 165 41, 165

Baseline uPCR (mg/mg)

Mean ±SD 4.4 ± 3.58 5.2 ± 4.15 4.5 ± 3.03 4.7 ± 3.62

Median 3.1 3.8 3.7 3.5

Min/Max 0.8, 19.3 0.8, 29.7 1.0, 17.4 0.8, 29.7

AURA: Baseline Clinical Characteristics

20

20


AURA: Renal Response (Remission) Rates at 24 & 48 weeks

Endpoint Treatment24

weeksOdds ratio

(95% CI)P-value*

48 weeks

Odds Ratio(95% CI)

P-value*

CompleteRemission

(CR)

23.7mg VCS BID 32.6% 2.03 (1.01, 4.05) p=.045 49.4% 3.21 (1.68, 6.13) p<.001

39.5mg VCS BID 27.3% 1.59 (0.78, 3.27) p=.204 39.8% 2.10 (1.09, 4.02) p=.026

Control 19.3% NA NA 23.9% NA NA

Partial Remission

(PR)

23.7mg VCS BID 70% 2.33 (1.68, 6.13) p=.007 68% 2.34 (1.27, 4.33) p=.007

39.5mg VCS BID 66% 2.03 (1.10, 3.76) p=.024 72% 2.68 (1.43, 5.02) p=.002

Control 49% NA NA 48% NA NA

21

*p-values are vs control group

First global trial in active LN to meet its primary endpoint

www.auriniapharma.com 22

23.7mg BID VCS demonstrates statistically significant CR & PR rates at 24 & 48 weeks

AURA: Improved CR & PR Over Time with Voclosporin

0%

10%

20%

30%

40%

50%

60%

Pat

ien

ts a

chie

vin

g C

R

Progression to Complete Remission

Control VCS 23.7mg BID VCS 39.5mg BID

p=.045

p<.001

0%

10%

20%

30%

40%

50%

60%

70%

80%

Baseline 24 weeks 48 weeks

Progression to Partial Remission

Control VCS 23.7mg BID VCS 39.5mg BID

p=.007

p=.007

p=.026

p=.002

p=.024


AURA: Speed of Remission

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P-Value <0.001 for both LD-VCS and HD-VCS

A statistically significant faster time to CR & PR compared to the control group

www.auriniapharma.com24

AURA Pre-specified Analysis: UPCR (mg/mg) (Mean ± SD) Over Time

0

1

2

3

4

5

6

7

8

9

10

Baseline Week 2 Week 4 Week 6 Week 8 Week 12 Week 16 Week 20 Week 24 Week 48 Week 50

UP

CR

(m

g/m

g)

Visit

UPCR (Mean ± SD) Over Time

p=.009

p<.001

www.auriniapharma.com25

AURA: Mean Change from Baseline in SELENA-SLEDAI Score 24 & 48 weeks

-4.5

-5.3

-6.3

-7.9

-7.1

-8.3

Mean Change from Baseline in SELENA-SLEDAI Score

Control Voclosporin 23.7 mg BID Voclosporin 39.5 mg BID

p=.003

p=.003

p=.003p<.001

A statistically significant improvement in reduction of SLEDAI score vs. baseline in both VCS arms vs. patients in the control group

Mean Change from Baseline at 24 weeks Mean Change from Baseline at 48 weeks


AURA Pre-specified Analysis:Ds-DNA Antibody (Mean ± SD) Over Time

26

1.75

21.75

41.75

61.75

81.75

101.75

121.75

141.75

161.75

181.75

Baseline Week 2 Week 4 Week 6 Week 8 Week 12 Week 16 Week 20 Week 24 Week 48

dsD

NA

An

tib

od

y (I

U/m

L)

Visit

Anti-dsDNA (Mean ± SD) Over Time

p=.006

p=.01


Safety

28


AURA: Summary of TEAEs & Historical Comparison

29

1.Furie R. et al., Arthritis and Rheumatology, Vol. 66, No 2, February 2014

2. Appel GB, et al. J Am Soc Nephrol. 2009;20(5):1103-1112 – Aspreva Lupus Management Study (Induction)3.Mysler, E. et al., Arthritis and Rheumatism, Vol. 65, No 9, September 2013, 2368-2379

4. AURA-LV Study results – Aurinia data on file

Treatment Emergent Adverse Events(TEAE)*

*includes TEAES following treatment period

ControlN = 88n (%)

VCS 23.7 mg BID N = 89n (%)

VCS 39.5 mg BIDN = 88n (%)

Any TEAE 78 (88.6) 82 (92.1) 85 (96.6)

Any Serious TEAE 17 (19.3) 25 (28.1) 22 (25.0)

Any TEAE with Outcome of Death 4 (4.5) 10 (11.2) 2 (2.3)

Any Treatment-Related TEAE 15 (17.0) 45 (50.6) 55 (62.5)

Any Serious Treatment-Related TEAE 1 (1.1) 4 (4.5) 7 (8.0)

AURA-LV4

N=265(to Dec 18th/16)

ALMS Induction2

N=364Abatacept Study1

MMF N = 298Ocrelizumab Study3

N=378

SAE’s, Subjects, n (%) 59 (22.3%) (25.3%) 92 (30.9%) 107 (28.3%)

Serious Infections, Subjects n (%)

29 (10.9%) (10.9%) 58 (19.5%) 64 (16.9%)

Deaths, Subjects, n (%) 13 (4.9%) 14 (3.8%) 14 (4.7%) 14 (3.7%)


Renal Function: eGFR (mL/min/1.73m²) over time

30

Renal function remains stable throughout treatment period; eGFR returns to baseline after 48 weeks


AURA: Blood Pressure (BP) (Mean ± SD) over 48 weeks

31

80

90

100

110

120

130

140

150

160

Baseline Day 1 Week 2 Week 4 Week 6 Week 8 Week 12 Week 16 Week 20 Week 24

Syst

olic

Blo

od

Pre

ssu

re (

mm

Hg)

Visit

Systolic BP (Mean ± SD) Over Time

Week 48

50

60

70

80

90

100

110

Baseline Day 1 Week 2 Week 4 Week 6 Week 8 Week 12 Week 16 Week 20 Week 24 Week 48

Dia

sto

lic B

loo

d P

ress

ure

(m

mH

g)

Visit

Diastolic BP (Mean ± SD) Over Time

No significant difference in blood pressure over the 48-week treatment period

www.auriniapharma.com 32

ControlN = 88n (%)

VCS 23.7 mg BID N = 89n (%)

VCS 39.5 mg BIDN = 88n (%)

Diarrhea 14 (15.9) 16 (18.0) 14 (15.9)

Nausea 7 (8.0) 16 (18.0) 11 (12.5)

Cough 3 (3.4) 16 (18.0) 5 (5.7)

Vomiting 10 (11.4) 15 (16.9) 9 (10.2)

Anemia 7 (8.0) 13 (14.6) 14 (15.9)

Upper respiratory tract infection 14 (15.9) 12 (13.5) 18 (20.5)

Urinary tract infection 5 (5.7) 8 (9.0) 6 (6.8)

Pneumonia 2 (2.3) 7 (7.9) 7 (8.0)

Pyrexia 1 (1.1) 6 (6.7) 10 (11.4)

Dyslipidemia 6 (6.8) 6 (6.7) 7 (8.0)

Edema 1 (1.1) 2 (2.2) 5 (5.7)

Leukopenia 6 (6.8) 1 (1.1) 3 (3.4)

AURA: Key Adverse Events


AURA: Safety Summary

33

1 Furie R. et al., Arthritis and Rheumatology, Vol. 66, No 2, February 2014

2 Appel GB, et al. J Am Soc Nephrol. 2009;20(5):1103-1112 – Aspreva Lupus Management Study (Induction)3.Mysler, E. et al., Arthritis and Rheumatixm, Vol. 65, No 9, September 2013, 2368-2379

The overall safety profile is consistent with other immunomodulators

No new safety signals were observed with the use of voclosporin in LN patients; voclosporin was well-tolerated

In previous studies (other indications), >2000 patients have been treated with voclosporin with no abnormal or unexpected SAE’s—this remains the case upon review of the AURA data

Safety beyond 24 weeks Control N = 88n (%)

VCS23.7 mg BID

N = 89 (n (%)

Any Serious Adverse Event 1 (1.1) 2 (2.2)

Malignancies 1 (1.1)^ 0 (0)

Deaths 3 (3.4)* 0 (0)

^Malignancy (metastatic melanoma) occurred following treatment period*3 deaths occurred following the treatment period (after week 50)

13 deaths have been reported in the AURA study: pattern is consistent with other global Active LN

studies1,2,3

11 of 13 deaths occurred at sites with compromised access to SoC; patients who died had a statistically different clinical baseline picture, demonstrating a

more severe form of LN, potential comorbid conditions & poor nutrition


AURA: CONCLUSIONS

First therapeutic agent to meet ALL KEY 24 & 48 week pre-specified secondary endpoints in global clinical trial for active LN.

VCS 23.7mg BID dose demonstrated a statistically significantly higher CR at both weeks 24 & 48 vs. patients in the control group (p=.045); (p<.001).

VCS 23.7mg BID achieved all secondary endpoints evaluated to date including time to remission/response and statistically significant reduction in UPCR and SLEDAI at 24 & 48 weeks.

This multi-target approach allowed for clinical response to be achieved using a Steroid-reduced protocol

Adverse events were more common in the VCS-treated groups but SAEs were similar to other LN trials.

These findings suggest that Voclosporin in addition to SOC may lead to improved outcomes in a multi-ethnic, multi-racial LN Population. A global placebo-controlled Phase III trial for voclosporin 23.7mg BID is scheduled to begin imminently


Principal Investigators

Ihar AdzerikhkoElena MikhailovaNatalya MitkovskayaSergey PimanovNikolay Soroka

Boris Iliev BogovBoriana DeliyskaValentin IkonomovEduard Tilkiyan

Ruth AlmeidaFernando JimenezFaud TeranIrma TchokhonelidzeNino Tsiskarishvili

Maynor Herrera MendezNilmo Noel Chavez Perez

Shue-Fen LuoTien-Tsai Cheng

Arturo Reyes LoaezaSergio Ramon UrenaJuanita Romero DiazPablo Estaley SansonRodolfo Araiza CasillasMagdalena Rovalo

Stanislaw NiemczykAntoni SokalskiAndrezj WiecekMarian Klinger

Dragan JovanovicBranka MiticMilan RadovicGoran Radunovic

Patricia CarreiraFederico GonzalezXavier FulladosaEduardo Ucar

Brancha SatirapojKajohnsak Noppakun

Olga BugrovaTatiana ChenykhTatiana KamenevaLidia LysenkoTatiana RaskinaOlga ReshetkoNatalia VezikovaTatiana KropotinaAdelya MaksudovaVyacheslav MarasaevVladimir DobronravovIvan GordeevMikhail BatyushinVladimir RyasnyanskyAshot EssaianAlexey Frolov

Iryna DudarOlga GodlevskaSvitlana KorneyevaViktoriia VasyletsNataliya SydorMykola Kolesnyk

Samir ParikhNancy OlsenEllen GinzlerJames TumlinAmit SaxenaRamesh SaxenaRichard LafayetteWilliam Pendergraft IIIAmber PodollMichael BubbJennifer GrossmanAlejandro I OportaAlireza Nami

Shamila De SilvaChula HerathAnura HewageeganaAbdul Latiff Mohamed NazarA.W.M Wazil

Mujibur RahmanSyed Atiqul Haq

Tak Mao Daniel Chan Mo Yin Mok

Harold Michael P. GomezJoseph AntiguaBernadette Heizel ReyesLlewellyn T. HaoLinda Charmaine RobertoEric AmanteSandra NavarraAllan Lanzon

Jung-Yoon ChoeTae Young KangYon Su KimSeung-Geun LeeJi Soo Lee

Jason Choo Chon JunArchana Vasudevan

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ACKNOWLEDGEMENTS


Panel Discussion/Q&A

Moderated by Simrat Randhawa, Head of Medical Affairs, Aurinia

37

Thank You

[email protected]

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national kidney foundation spring clinical meeting · 4/29/2017 · national kidney foundation...

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