Exhibit 99.1
Aurinia Announces Development Plans for Voclosporin in Europe and Japan
- Single Phase III trial (AURORA) to serve as basis for regulatory submissions in major markets—US, Europe, and Japan
VICTORIA, British Columbia--(BUSINESS WIRE)--April 6, 2017--Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (“Aurinia” or the “Company”), today announced the outcome of discussions with both the European Medicines Agency (EMA) and the Pharmaceutical and Medical Devices Agency (PMDA) in Japan regarding the development of voclosporin for the treatment of active lupus nephritis (LN). Pursuant to these discussions, the Company believes that the confirmatory data that can be generated from the single Phase III clinical trial (AURORA) and the recently completed AURA-LV (AURA) Phase IIb study should support regulatory submissions in the US, Europe and Japan.
“Our interactions with regulators in all three jurisdictions have given us a clear pathway for Phase III, and we are confident in our ability to execute AURORA successfully based on their feedback and the information gleaned from the AURA study,” said Lawrence D. Mandt, Vice President of Quality and Regulatory Affairs at Aurinia. “The productive conclusion of these regulatory interactions marks a milestone in our development program and brings this exciting new therapeutic option one step closer to those patients suffering from LN.”
The Phase III AURORA trial will be a global 52-week double-blind, placebo controlled study of approximately 320 patients. Patients will be randomized 1:1: to either of 23.7mg voclosporin BID and mycophenolate mofetil (MMF) or MMF and placebo, with both arms receiving a stringent oral corticosteroid taper. As in AURA, the study population will be comprised of patients with biopsy-proven active LN who will be evaluated on the primary efficacy endpoint of complete remission, or renal response, at 52 weeks, a composite which includes:
“Based on the recent learnings from the positive AURA study at 48 weeks, we intend to use a UPCR of ≤0.5mg/mg and evaluate the primary endpoint at 52 weeks in AURORA,” added Richard M. Glickman, Aurinia’s Chief Executive Officer. “We are on track to initiating the global AURORA study this quarter and fulfilling our goal of improving the long-term outcomes for patients with this disease.”
About AURORA
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.
About AURA-LV
The AURA–LV study (Aurinia Urinary
Protein Reduction in Active Lupus with Voclosporin) was 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 complete remission (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 with
top-line 48-week results announced in Q1 2017. The 48-week data has been
accepted for a late-breaking presentation at National Kidney Foundation
(NKF) Spring Clinical Meeting taking place April 18-22 in Orlando, FL.
About Voclosporin
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
other countries.
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
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 where an early response
correlates with long-term outcomes, measured by proteinuria. In patients
with LN, renal damage results in proteinuria and/or hematuria and a
decrease in renal function as evidenced by reduced estimated glomerular
filtration rate (eGFR), and increased serum creatinine levels. LN is
debilitating and costly and if poorly controlled, LN can lead to
permanent and irreversible tissue damage within the kidney, resulting in
end-stage renal disease (ESRD), thus making LN a serious and potentially
life-threatening condition.
About Aurinia
Aurinia is a clinical stage
biopharmaceutical company focused on developing and commercializing
therapies to treat targeted patient populations that are suffering from
serious diseases with a high unmet medical need. The company is
currently developing voclosporin, an investigational drug, for the
treatment of LN. The company is headquartered in Victoria, BC and
focuses its development efforts globally. www.auriniapharma.com.
Forward Looking Statements
This press release contains
forward-looking statements, including statements around Aurinia's global
development and regulatory strategy, analysis, assessment and
conclusions around the future development and commercial potential of
voclosporin. It is possible that such results or conclusions may change
based on further analyses of these data. Words such as "plans,"
"intends," “may,” "will," "believe," and similar expressions are
intended to identify forward-looking statements. These forward-looking
statements are based upon Aurinia’s current expectations.
Forward-looking statements involve risks and uncertainties. Aurinia’s
actual results and the timing of events could differ materially from
those anticipated in such forward-looking statements as a result of
these risks and uncertainties, which include, without limitation, the
risk that Aurinia’s analyses, assessment and conclusions of the results
of the future development and commercial potential of voclosporin set
forth in this release may change based on further analyses of such data,
and the risk that Aurinia’s clinical studies for voclosporin may not
lead to regulatory approval. These and other risk factors are discussed
under "Risk Factors" and elsewhere in Aurinia’s Annual Information Form
for the year ended December 31, 2016 filed with Canadian securities
authorities and available at www.sedar.com and on Form 40-F with
the U.S. Securities Exchange Commission and available at www.sec.gov,
each as updated by subsequent filings, including filings on Form 6-K.
Aurinia expressly disclaims any obligation or undertaking to release
publicly any updates or revisions to any forward-looking statements
contained herein to reflect any change in Aurinia's expectations with
regard thereto or any change in events, conditions or circumstances on
which any such statements are based.
CONTACT:
Aurinia Pharmaceuticals Inc.
Investor & Media
Contact:
Celia Economides
Head of IR & Communications
ceconomides@auriniapharma.com
or
Media:
Christopher
Hippolyte, 212-364-0458
Christopher.hippolyte@inventivhealth.com