Late breaking abstract showcases first global
study of active lupus nephritis to meet its primary endpoint,
presented on November 15th
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.”
Speed of Remission
Analyses Control
Voclosporin23.7mg BID
Post-hoc Responder Analysis (Median time to CR for those who
achieve CR) 12 weeks 7.3 weeks
Pre-Specified
Endpoint: Time to Complete Remission (TTCR) [median] Not
achieved 19.7 weeks
p<.001
Pre-Specified Endpoint: Time to Partial Remission (TTPR)
[median] 6.6 weeks 4.1 weeks
p=.002
“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 in Q1 2017.
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.
About AURION
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.
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 Voclosporin
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
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 lupus
nephritis (LN). The Company is headquartered in Victoria, BC and
focuses its development efforts globally. Visit
www.auriniapharma.com for more information.
Forward Looking Statements
This press release contains forward-looking statements,
including statements related to Aurinia's regulatory strategy,
Aurinia's analysis, assessment and conclusions of the results of
the AURA-LV clinical study, and the efficacy 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 AURA-LV clinical study 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, 2015 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.
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Aurinia Pharmaceuticals Inc.Celia EconomidesHead of IR &
Communicationsceconomides@auriniapharma.com