Full Press Release Details
Pharmaceuticals to Initiate an Open Label Clinical Study to Investigate
the Impact of Voclosporin on Lupus Nephritis Biomarkers
VICTORIA, British Columbia--(BUSINESS WIRE)--February 9, 2015--Aurinia
Pharmaceuticals Inc. (the "Company") (NASDAQ:AUPH) (TSX:AUP) today
announced that it will initiate an open label, exploratory study to
assess the short term predictors of response using voclosporin in
combination with mycophenolate mofetil in patients with active lupus
nephritis. AURION (Aurinia early Urinary protein Reduction
Predicts Response) will examine biomarkers of disease activity at 8
weeks and their ability to predict response at 24 and 48 weeks. The
Company expects to complete patient enrolment of this small pilot study
by the 3rd quarter of this year.
The Company expects that this study will act in support of its ongoing
lupus nephritis clinical program. This study should provide the lupus
community with a more clear understanding of voclosporin's time to onset
of action and clinical outcomes.
In the Aspreva Lupus Management Study
(ALMS), one of the largest registration quality studies ever completed
that investigated the treatment of lupus nephritis, certain biomarkers
after 8 weeks were extremely predictive of 24 week response rates. "We
believe the AURION study has the potential to provide validation for
these early biomarkers and provide valuable tools to clinicians who are
managing patients with this debilitating disease," said Dr. Neil
Solomons, MD, Chief Medical Officer of Aurinia Pharmaceuticals Inc. and
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 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.
Voclosporin is a novel and potentially best in class 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.
Aurinia also has development and commercialization partners in Canada,
Israel, South Africa and Greater China. Visit www.auriniapharma.com,
www.sedar.com and www.sec.gov for more information.
The Aspreva Lupus Management Study (ALMS) incorporated a six month
induction phase comparing mycophenolate mofetil (MMF) to
Cyclosphosphamide, and this data was published in the Journal of the
American Society of Nephrology in 2009. Following the ALMS induction
phase a three year maintenance period was studied comparing MMF and
Azathioprine, and this data was published in the New England Journal of
Aurinia Pharmaceuticals Inc.
Stephen Zaruby, 250-708-4293
& Chief Executive Officer
R. Martin, 250-708-4272
Chief Operating Officer