- Single Phase 3 Trial on track to commence in
Q2 2017
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP)
(“Aurinia” or the “Company”), a clinical stage biopharmaceutical
company focused on the global immunology market, today announced
that it has selected Worldwide Clinical Trials (“Worldwide”) as its
Clinical Research Organization (CRO) for the AURORA Phase 3 study
of volcosporin for the treatment of active lupus nephritis
(LN).
“Selecting a CRO for AURORA is a key milestone for Aurinia
following our successful end-of-Phase 2 meeting with the U.S. Food
& Drug Administration (FDA) Division of Pulmonary, Allergy and
Rheumatology Products. We are thrilled to partner with Worldwide to
support the AURORA Phase 3 clinical trial,” said Charles Rowland,
Chief Executive Officer of Aurinia. “We are rapidly moving forward
with our plans to bring this important therapy to market for
patients living with this devastating disease, and Worldwide’s deep
expertise and capabilities in managing pivotal trials will be a
tremendous asset to us. We are on track to commence the AURORA
trial in the second quarter of 2017, and we expect the results from
this study will support a New Drug Application (NDA) submission to
the FDA.”
With support from Worldwide, Aurinia will proceed with
conducting a randomized, placebo-controlled, double-blind global
52-week trial in approximately 320 patients. The primary endpoint
as in the Phase 2b AURA trial is renal response (complete
remission), at 24 weeks. In addition to the assessment of renal
response, a key marker of clinical benefit in this population is
the duration of proteinuria improvement. Therefore, secondary
endpoints will include the duration of renal response at 52 weeks
(48 weeks in AURA), an efficacy measure which delineates durability
of renal response (remission), an important parameter in evaluating
long-term outcomes for the treatment of LN.
“Our entire Worldwide team is delighted to have been selected as
Aurinia’s CRO partner to advance voclosporin, which has the
potential to become the first FDA-approved treatment for LN,” said
Peter Benton, President and Chief Operating Officer at Worldwide
Clinical Trials. “We’re truly honored that an innovator like
Aurinia recognizes what Worldwide brings to the table: medical and
scientific expertise, proactive insight, dogged determination,
rigorous processes and a commitment to getting it right. We’re
looking forward to working closely with Aurinia’s clinical
development team on this new therapy, which could significantly
improve the lives and long-term outcomes of patients suffering from
LN.”
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 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. 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 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.
www.auriniapharma.com.
About Worldwide Clinical Trials
Worldwide Clinical Trials employs more than 1,400 professionals
around the world, with offices in North and South America, Eastern
and Western Europe, Russia and Asia. One of the world’s leading,
full-service contract research organizations (CROs), we partner
with sponsors in the pharmaceutical and biotechnology industries to
deliver fully integrated clinical development and bioanalytical
services, extending from first-in-human through phase IV studies.
Grounded in medicine and science, we help sponsors move from
discovery into clinical development and commercialization across a
range of therapeutic areas, including neuroscience, cardiovascular
diseases, immune-mediated inflammatory disorders (IMID), and rare
diseases. For more information, visit www.Worldwide.com.
Forward Looking Statements
This press release contains forward-looking statements,
including statements related to Aurinia's clinical and regulatory
strategy, future clinical development plans, Aurinia's analysis,
assessment and conclusions of the results of the AURA-LV clinical
study. 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.Investor & Media
Contact:Celia EconomidesHead of IR &
Communicationsceconomides@auriniapharma.comorWorldwide Clinical
Trials Media Contact:LuJean Smith, +1.610.329.2056Vice
President, Global Marketing
Communicationslujean.smith@worldwide.com