258-Patient, Multinational, Randomized, Double-Blind, Placebo-Controlled AURA
Study to Evaluate Voclosporin as Part of a Multi-Targeted Therapeutic Regimen
VICTORIA, BRITISH COLUMBIA – June 26, 2014 – Aurinia Pharmaceuticals, Inc., (TSX: AUP)
today announced enrollment of the first patient in its planned Phase 2b clinical trial to evaluate
the efficacy of voclosporin as a treatment for lupus nephritis (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. The Lupus Foundation of America believes there are
as many as 1.5 million people in the U.S. with systemic lupus erythematosus (SLE),
approximately 40 to 70 percent of whom will develop LN.
The Phase 2b trial, called AURA–LV (Aurinia Urine protein Reduction in Active Lupus with
voclosporin) or AURA, is planned to be conducted in approximately 20 countries and is a
randomized, controlled, double-blind study comparing the efficacy of voclosporin against
placebo in achieving remission in patients with active LN. The AURA 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 SLE. The Company expects patient recruitment to be completed within approximately
12 months.
“We aim to advance our development of voclosporin to treat lupus nephritis given the significant
unmet need, lack of approved therapies and market opportunity,” said Stephen Zaruby,
President and CEO of Aurinia. “The immunology of LN, along with significant published data,
support the use of a multi-targeted treatment approach for this debilitating and heterogeneous
disease.”
About Voclosporin
Voclosporin is a novel calcineurin inhibitor (CNI) with extensive clinical data in over 2,600
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. These attributes have the potential to position voclosporin as a best in class CNI
inhibitor.
About Aurinia
Aurinia is a clinical stage pharmaceutical company focused on the global nephrology market. Its
lead drug, voclosporin, is a novel CNI. Aurinia holds global rights to all indications for
voclosporin and has development and commercialization partners in Canada, Israel, South
Africa and Greater China. Visit www.auriniapharma.com for more information.
Forward-looking Statements
This press release contains forward-looking statements. The forward-looking statements may
include, without limitation, statements regarding number of countries in which AURA will be
conducted, the timeline for completion of potential recruitment for AURA, and voclosporin being
a best in class CNI inhibitor. Such forward-looking statements involve known and unknown
risks, uncertainties and other factors that may cause actual results, events or developments to
be materially different from any future results, events or developments expressed or implied by
such forward looking statements. Such risks and uncertainties include, among others, the ability
of the Company to protect its intellectual property rights, delays in the recruitment process, not
identifying and enrolling sufficient patients, the potential of its products, the success and timely
completion of clinical studies and trials, the Company’s and its partners’ ability to successfully
obtain and maintain regulatory approvals and commercialize voclosporin on a timely basis.
These factors should be considered carefully and readers are cautioned not to place undue
reliance on such forward-looking statements. For additional information on risks and
uncertainties relating to these forward-looking statements, investors should consult the
Company’s annual reports and its most recent Annual Information Form and other filings found
on SEDAR at www.sedar.com.
We seek Safe Harbour.
Company Contact:
Stephen Zaruby
President & CEO
250-708-4293
szaruby@auriniapharma.com
or
Michael R. Martin
Chief Operating Officer
250-708-4272
mmartin@auriniapharma.com
