Full Press Release Details
Confirms Receipt of FDA End of Phase 2 Meeting Minutes
are consistent with previously issued preliminary responses from FDA
Phase 3 clinical trial to be conducted with 23.7mg BID voclosporin for
the treatment of active lupus nephritis (LN)
on track to commence in Q2 2017
VICTORIA, British Columbia--(BUSINESS WIRE)--December 13, 2016--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 received the final
End of Phase II (EOP2) meeting minutes from the U.S. Food & Drug
Administration Division of Pulmonary, Allergy and Rheumatology Products.
The minutes are consistent with the preliminary responses that were
issued to the Company prior to the meeting which took place on October
As previously communicated, Aurinia will be conducting a single, Phase 3
clinical trial assessing 23.7mg BID for the treatment of active lupus
nephritis (LN). The trial, which will be known as AURORA, will be a
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.
Aurinia believes this Phase 3 clinical trial will support a New Drug
Application (NDA) submission.
"We have thoroughly reviewed the final EOP2 meeting minutes provided to
us by FDA, which are consistent with our previous assessment and are
moving as quickly as we can to initiate the AURORA trial," commented
Lawrence D. Mandt, Vice President of Quality and Regulatory Affairs at
"We are pleased to be working closely with FDA to bring this treatment
to market and helping as many people as possible suffering from this
debilitating disease," added Charles Rowland, Aurinia's Chief Executive
Officer. "Our clinical team has been working on preparations for this
important trial to meet our goal of enrolling the first patient in Q2
2017. In the meantime, we expect the AURA 48-week secondary endpoint
durability of renal response data in Q1 next year."
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. The drug has received "Fast Track
Designation from the U.S. FDA. 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.
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.
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.
We seek safe harbor.
Forward Looking Statements
This press release contains forward-looking statements, including
statements related to Aurinia's regulatory strategy, and projections
regarding the Phase III AURORA clinical trial 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