Aurinia Announces Voclosporin Meets 48-Week Remission Endpoints, Achieving Highest Complete Remission Rate of Any Global Lupus Nephritis Study - Low dose voclosporin achieves CR rate of 49.4% at 48 weeks (p .001) - AUROR

Announces Voclosporin Meets 48-Week Remission Endpoints, Achieving

Highest Complete Remission Rate of Any Global Lupus Nephritis Study

dose voclosporin achieves CR rate of 49.4% at 48 weeks (p<.001)

Phase III trial with low dose voclosporin on track to commence in Q2 2017

Conference call & webcast 8:30am ET tomorrow

VICTORIA, British Columbia--(BUSINESS WIRE)--March 1, 2017--Aurinia

Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) ("Aurinia" or the

"Company"), a clinical stage biopharmaceutical company focused on the

global immunology market, today announced top-line results from its

Phase IIb AURA-LV (AURA) study in lupus nephritis (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 (MMF) 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. Additional data analyses for the AURA study at 48

weeks will be released at future corporate, medical and scientific

"Lupus nephritis (LN) is one of the most severe complications of

systemic lupus erythematosus. The current treatments of LN are toxic and

the complete renal response rates are unacceptably low. For the last

several years the community of lupus researchers in collaboration with

the pharmaceutical industry have been engaged in finding more effective

therapies for LN, but success has been difficult to achieve," said Brad

Rovin, MD, FASN, Director of Nephrology and Vice Chairman of Research

for the Department of Internal Medicine at the Ohio State University

Wexner Medical Center. "The AURA trial's long-term results convincingly

demonstrate that the addition of voclosporin to standard of care

treatment is superior to standard of care alone. These data are not only

statistically significant, but clinically important. Twice as many

patients given 23.7mg voclosporin twice daily achieved a complete renal

response compared to those treated with placebo. This is an impressive

renal response rate and these results may shift the treatment paradigm

of LN. Based on these encouraging data, I am looking forward to the

Phase III trial of voclosporin in LN."

The 24 and 48-week top-line efficacy results are summarized below:

*All p-values are vs control

"We are grateful to both the patients and investigators who have worked

with us on this groundbreaking program. Voclosporin is the first and

only treatment candidate that has demonstrated such a clear treatment

effect for LN patients," said Neil Solomons, MD, Aurinia's Chief Medical

Officer. "These data provide us with tremendous confidence that we can

execute a successful Phase III program and make a meaningful impact on

"Lupus nephritis carries with it life-threatening complications,

including kidney failure. The treatment of the disease is challenging,

and steroid side-effects are often difficult for patients to endure. The

National Kidney Foundation supports the development of steroid-sparing

treatment options, and we look forward to following the results of the

Phase III trial," said Joseph Vassalotti, MD, Chief Medical Officer,

National Kidney Foundation.

Conference Call and Webcast Details

conference call and webcast tomorrow, March 2, 2017 at 8:30am Eastern

Standard Time to provide an overview of the AURA 48-week top-line

results. In order to participate in the conference call, please dial

+1-877-407-9170 (Toll-free U.S. & Canada). An audio webcast can be

accessed under "News/Events" through the "Investors" section of the

Aurinia corporate website at www.auriniapharma.com. A replay

of the webcast will be available on Aurinia's website.

The AURA-LV study (Aurinia Urinary

protein Reduction in Active Lupus with Voclosporin) is a 48-week study

comparing the efficacy of two doses of voclosporin added to current

standard of care of MMF against standard of care with placebo in

achieving CR in patients with active LN. All arms also received low

doses of corticosteroids as background therapy. 265 patients were

enrolled at centers in 20 countries worldwide. On entry to the study,

patients were required to have a diagnosis of LN according to

established diagnostic criteria (American College of Rheumatology) and

clinical and biopsy features indicative of highly active nephritis. The

24-week primary and secondary endpoints were released in Q3 2016 where

the primary and all secondary endpoints were met. CR is a composite

endpoint that includes: confirmed UPCR of 0.5 mg/mg; normal, stable

renal function ( 60 mL/min/1.73m2 or no confirmed

decrease from baseline in eGFR of 20%); presence of sustained, low dose

steroids ( 10mg prednisone from week 16-24); and no administration of

rescue medications. PR in the trial is measured by a 50% reduction in

UPCR with no concomitant use of rescue medication.

Voclosporin, an investigational drug,

is a novel and potentially best-in-class calcineurin inhibitor ("CNI")

with clinical data in over 2,200 patients across indications.

Voclosporin is an immunosuppressant, with a synergistic and dual

mechanism of action that has the potential to improve near- and

long-term outcomes in LN when added to standard of care (MMF). By

inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell

mediated immune responses. It is made by a modification of a single

amino acid of the cyclosporine molecule which has shown a more

predictable pharmacokinetic and pharmacodynamic relationship, an

increase in potency, an altered metabolic profile, and potential for

flat dosing. The Company anticipates that upon regulatory approval,

patent protection for voclosporin will be extended in the United States

and certain other major markets, including Europe and Japan, until at

least October 2027 under the Hatch-Waxman Act and comparable laws in

About Lupus Nephritis (LN)

LN in an inflammation of the

kidney caused by Systemic Lupus Erythematosus ("SLE") and represents a

serious progression of SLE. SLE is a chronic, complex and often