Aurinia Pharmaceuticals Announces Outcome from Data and Safety Monitoring Board for Its Phase 2b Study in Lupus Nephritis - Study to Continue as Planned VICTORIA, British Columbia--(BUSINESS WIRE)

Pharmaceuticals Announces Outcome from Data and Safety Monitoring Board

for Its Phase 2b Study in Lupus Nephritis - Study to Continue as Planned

VICTORIA, British Columbia--(BUSINESS WIRE)--November 24, 2015--Aurinia

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

has announced today that the independent Data and Safety Monitoring

Board ("DSMB") for the Company's Phase 2b lupus nephritis study, known

as AURA-LV, has completed its third pre-planned safety review of

patients enrolled in the study and recommended continuation of the trial

without any modifications. The AURA-LV DSMB has been established

according to the FDA Guidance for Clinical Trial Sponsors and is guided

by its charter. Aurinia remains blinded to the actual safety and

The DSMB reviewed all the safety data from more than 200 patients that

had been enrolled and randomized at the time the data was requested.

This included adverse events, laboratory results and compliance with the

"We are encouraged by the recommendations of the DSMB," said Stephen W.

Zaruby, President and CEO of Aurinia. "The safety profile of voclosporin

has been well characterized in the clinic with over 2,000 patients

having received voclosporin in other clinical trials to date, outside of

lupus nephritis. It is important that having assessed the data emerging

from this study, the DSMB's view on the safety profile remains

Aurinia anticipates completion of patient enrollment in the AURA-LV

study around the end of 2015. Additionally, the Company continues to

recruit patients into its AURION study and expects to review data early

Aurinia is a clinical stage pharmaceutical company focused on the global

nephrology market. It is currently enrolling patients in its Phase 2b

clinical trial to evaluate the efficacy of its drug, voclosporin, as a

treatment for LN. LN is an inflammation of the kidneys, that if

inadequately treated can lead to end-stage renal disease, making LN a

serious and potentially life-threatening condition.

Voclosporin is a novel and potentially best-in-class calcineurin

inhibitor ("CNI") with extensive clinical data in over 2,000 patients in

other indications. Voclosporin is made by a modification of a single

amino acid of the cyclosporine molecule (a CNI approved for use in

transplant patients since 1983). This modification results in a more

predictable pharmacokinetic and pharmacodynamic relationship, an

increase in potency vs. cyclosporine, an altered metabolic profile, and

potential for flat dosing.

The AURA-LV study or "Aurinia Urine Protein Reduction in Active Lupus

Nephritis Study" is an adequate and well controlled clinical trial that

is being conducted in 20 countries worldwide and is expected to enroll

approximately 258 patients which will compare the efficacy of

voclosporin against placebo in achieving remission in patients with

active lupus nephritis. The AURA-LV study is designed to demonstrate

that voclosporin can induce a rapid and sustained reduction of

proteinuria in the presence of extremely low steroid exposure and to

fulfill specific regulatory requests. It will compare two dosage groups

of voclosporin (23.7mg and 39.5mg) administered with mycophenolate

mofetil (MMF) vs. MMF alone. All patients will also receive oral

corticosteroids as background therapy. There will be a primary analysis

to determine complete remission at week 24 and various secondary

analyses at week 48 which include biomarkers and markers of non-renal

The AURION study or "Aurinia Early Urinary Protein Reduction Predicts

Response Study" is an open label, exploratory study being conducted in

multiple sites in Malaysia to assess the short term predictors of

response using voclosporin in combination with mycophenolate mofetil in

patients with active lupus nephritis. This study will examine biomarkers

of disease activity at 8 weeks and their ability to predict response at

We seek Safe Harbor.

Aurinia Pharmaceuticals Inc.

Chief Operating Officer

Stephen W. Zaruby, 250-708-4293

Chief Executive Officer

Financial Communications Inc.

Tel: 416-644-2020 or