Aurinia Presents Additional Data from Phase Iib Aura-Lv Study, Demonstrating Stable Renal Function and Blood
Pressure without Electrolyte Complications Through 48 Weeks
-Data highlight voclosporin’s additional differentiation from its therapeutic class
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH)(TSX:AUP) (“Aurinia” or the “Company”) a clinical stage biopharmaceutical company
focused on the global immunology market, presented additional data from its global Phase IIB AURA-LV (AURA) study in lupus
nephritis (LN) during the 54th European Renal Association-European Dialysis and Transplant Association Congress (ERA-EDTA) in
Madrid, Spain. The data were presented yesterday during the late-breaking session by lead author James Tumlin, M.D., a clinical
investigator for the study and founder of Southeast Renal Research Institute.
As previously reported, treatment with low dose voclosporin showed statistically improved efficacy over the control arm at 24
and 48 weeks. These results were achieved in the presence of low doses of corticosteroids. Furthermore, all key pre-specified
secondary endpoints analyzed to date were met at 48 weeks. The data presented at ERA-EDTA demonstrated this improved efficacy was
attained while maintaining stable serum magnesium, potassium and blood pressure levels. Well-known side effects with other
calcineurin inhibitors at their effective dose include hypomagnesemia and hyperkalemia, which are associated with renal impairment
and require monitoring or intervention.
“We were very encouraged to observe that voclosporin therapy resulted in significantly improved remission rates without
compromising renal function and blood pressure or inducing electrolyte disorders,” stated Dr. Tumlin, Principal Investigator.
“Prolonged steroid therapy for lupus nephritis is associated with unwanted side-effects, and a reduction in steroid dose should be
a treatment goal. These encouraging data suggest that voclosporin can induce clinical remissions with low dose steroids while
minimizing renal toxicity.”
“Interestingly, voclosporin may involve a selective mechanism of action which could explain the apparent improvement of blood
pressure at 48 weeks from baseline, stable renal function, and the absence of hyperkalemia and hypomagnesemia over the treatment
period. Further studies are needed to delineate this potential mechanism,” said Neil Solomons, M.D., Aurinia’s Chief Medical
Officer. “The data provides us with a high degree of confidence that we can execute a successful Phase III program and make a
meaningful impact on patients’ lives.”
All arms of the study included the current standard of care of mycophenolate mofetil (MMF) as background therapy and an
aggressive steroid taper. Both doses of voclosporin at 48 weeks demonstrated continued improvement over the control group across
multiple measures. The voclosporin treated groups demonstrated statistically significant improvement in speed and rates of complete
and partial remission (CR and PR, respectively). Of the low-dose voclosporin patients that achieved CR at 24 weeks, 100% remained
in CR at 48 weeks, demonstrating durability of clinical response. Proteinuria levels and reduction in Systemic Lupus Erythematosus
Disease Activity Index (SLEDAI) scores, which include non-renal measures of lupus activity, also continued to significantly improve
over time versus the control group. Additional analyses are ongoing and will be presented at future medical and scientific
meetings.
No unexpected safety signals nor adverse events were observed and voclosporin was generally well-tolerated, consistent with what
is expected of patients suffering from highly active LN while undergoing immunomodulation-based therapy. In the voclosporin arms,
renal function as measured by estimated glomerular filtration rate (eGFR) was stable and not significantly different from the
control arm following the 48-week treatment period. There were no electrolyte changes in the treatment groups and mean blood
pressure was also similar across treatment groups through 48 weeks.
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 has been shown to have a more predictable
pharmacokinetic and pharmacodynamic relationship, an increase in potency, an altered metabolic profile and potential for flat
dosing compared to legacy CNIs. 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
percent of all SLE patients will develop clinical LN requiring treatment. Unlike SLE, LN has straightforward disease outcomes
(measuring proteinuria) where an early response correlates with long-term outcomes. 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 related to Aurinia’s ability to execute a
successful Phase III program and voclosporin’s potential differentiation from its therapeutic class, Aurinia's analysis, assessment
and conclusions of the results of the AURA-LV clinical study and timing of voclosporin’s patent protection. 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, the future success of a Phase III study and the timing of voclosporin’s patent protection
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, except as required by law.
Aurinia Pharmaceuticals Inc.
Investor Contact:
Celia Economides
Vice President, Public Affairs
ceconomides@auriniapharma.com
or
Media:
Christopher Hippolyte, 212-364-0458
Christopher.hippolyte@inventivhealth.com
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