Aurinia Highlights Speed of Remission from Global Phase IIb AURA Study of Voclosporin in Lupus Nephritis at 2016 American College of Rheumatology Annual Meeting Late breaking abstract showcases first global study of acti

Highlights Speed of Remission from Global Phase IIb AURA Study of

Voclosporin in Lupus Nephritis at 2016 American College of Rheumatology

breaking abstract showcases

global study of active lupus nephritis to meet its primary endpoint,

presented on November 15th

VICTORIA, British Columbia--(BUSINESS WIRE)--November 16, 2016--Aurinia

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

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

global immunology market, today highlighted additional findings from its

global Phase IIb AURA study of voclosporin in the treatment of lupus

nephritis (LN). The abstract was presented at the American College of

Rheumatology and Association of Rheumatology Health Professionals

(ACR/ARHP) Annual Meeting in Washington, D.C. during the Late-Breaking

News session on November 15, 2016.

The late-breaking abstract, titled, "Speed of Remission with the Use of

Voclosporin, MMF and Low Dose Steroids: Results of a Global Lupus

Nephritis Study," was presented by Mary Anne Dooley, M.D., M.P.H., of

the University of North Carolina Kidney Center. The global Phase IIb

AURA study of voclosporin, a novel immunosuppressant that has been

applied as a treatment for LN, is the first global active lupus

nephritis study to meet its primary endpoint. In addition, all secondary

endpoints in AURA were met, including demonstrating a more rapid

response rate for patients receiving voclosporin versus patients in the

control arm with most patients achieving complete remission (CR) at or

before the eighth week of the trial.

"Lupus nephritis is a devastating, often overlooked disease that

severely impacts a patient's quality of life and, in the worst cases,

can lead to end-stage renal disease or even death," said Dr. Dooley.

"The ability to get more patients into remission and in a shorter period

of time than the current standard of care can have a significant impact

on the long-term outcomes for these patients. We have demonstrated that

voclosporin successfully achieves not only higher complete remission

rates but does so more rapidly in patients with LN. I believe this

promising data has the potential to shift the standard of care and

improve long-term outcomes for patients with LN."

"This promising data emphasizes the importance of enhancing the

treatment options available for this debilitating disease," said Neil

Solomons, M.D., Aurinia's Chief Medical Officer. "The speed in which

patients achieved CR, which is consistent with our open-label AURION

study, is encouraging and we are absolutely delighted by the medical

community's reception to the data. We remain focused on advancing the

clinical development program for voclosporin, fulfilling our goal of

improving long-term outcomes for patients."

The AURA study enrolled 265 patients in 20 countries using low (23.7 mg

BID), high dose voclosporin (39.5 mg BID) or placebo added to standard

of care of mycophenolate mofetil (MMF) and steroids in active LN. The

study met its primary endpoint with statistically significant complete

remission rates in the 23.7mg BID arm, and demonstrated statistically

significant improvements across all secondary endpoints: Partial

Remission (PR); time to CR and PR; reduction in Systemic Lupus

Erythematosus Disease Activity Index or SLEDAI score; and reduction in

UPCR over the 24-week treatment period.

Adverse events were higher in the voclosporin treatment arms versus the

control arm, which is consistent with increased immunosuppression. The

overall mortality rate was similar to other recent global LN trials; all

were considered unrelated to the study drug. The AURA study remains

ongoing until its 48-week secondary endpoints, which will be available

Based on recent FDA feedback, Aurinia expects to initiate a single Phase

III clinical trial of voclosporin 23.7mg BID (AURORA) in Q2 2017.

Aurinia believes this Phase III clinical trial whose design is

consistent with the ongoing AURA study, will support a New Drug

Application (NDA) submission.

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 (23.7mg) in combination with mycophenolate

mofetil and oral corticosteroids in patients with active lupus

nephritis. This study will examine biomarkers of disease activity at 8

weeks and their ability to predict response at 24 and 48 weeks.

The AURORA study is a 52-week global double-blind placebo controlled

phase III study that will compare the efficacy of one dose of

voclosporin (23.7mg BID) or placebo added to current standard of care of

mycophenolate mofetil (MMF, also known as CellCept ) in achieving renal

response (formerly referred to as complete remission) in patients with

active LN. Both arms will also receive low doses of corticosteroids as

part of background therapy after a stringent taper.

Voclosporin, an investigational drug, is a novel and potentially

best-in-class calcineurin inhibitor ("CNI") with clinical data in over

2,000 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 other countries.

About Lupus Nephritis (LN)

Lupus Nephritis (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 disabling disorder and affects more

than 500,000 people in the United States (mostly women). The disease is

highly heterogeneous, affecting a wide range of organs & tissue systems.

It is estimated that as many as 60% of all SLE patients have clinical LN

requiring treatment. Unlike SLE, LN has straightforward disease outcomes