Mr. Neil
Solomons reports
AURINIA HIGHLIGHTS 48-WEEK DATA FROM OPEN-LABEL AURION STUDY AT 12TH INTERNATIONAL CONGRESS ON SLE (LUPUS 2017) & THE 7TH ASIAN CONGRESS ON AUTOIMMUNITY (ACA 2017)
Aurinia Pharmaceuticals Inc. has released the 48-week results from the
"Aurinia Early Urinary Protein Reduction Predicts Response Study"
(AURION) open-label study of voclosporin for the treatment of lupus
nephritis (LN) at the 12th International Congress on Systemic
Lupus Erythematosus and seventh Asian Congress on Autoimmunity
jointly in Melbourne, Australia. The data were presented by Robert B.
Huizinga, vice-president of clinical affairs at Aurinia.
The study successfully achieved its primary objective by demonstrating
that early biomarker response in active LN patients can be a significant
predictor of renal response at 24 and 48 weeks.
In the per-protocol analysis at 48 weeks, 71 per cent of subjects (n equals five/seven) on
treatment remain in complete remission as measured by a urinary protein
creatinine ratio (UPCR) of equals 0.5 milligram/mg, eGFR within 20 per cent of baseline and
concomitant steroid dose of less than five mg/day. A 25-per-cent reduction in UPCR at week
eight was found to be highly predictive of achieving renal response at
24 and 48 weeks. Conversely, if C3 and C4 do not normalize by week eight, then a renal response at week 24 and 48 is highly unlikely. Anti-dsDNA
was not found to be a useful biomarker in predicting long-term response
in LN patients.
No new safety signals were observed with the use of voclosporin in LN
patients; voclosporin was well tolerated, and the safety profile was
consistent with other immunomodulators. A total of three subjects were
discontinued prior to 48 weeks due to lupus-related complications or
investigator discretion.
"Results from AURION demonstrated that an early UPCR reduction of 25 per cent is
the best predictor of renal response at 24 and 48 weeks," said Neil
Solomons, MD, chief medical officer at Aurinia. "In addition, the use of
C3 or C4 improves the precision of predicting if a patient will achieve
a clinical response. This exploratory study is supportive of the
successful AURA phase 2b study and continues to inform us of optimal
ways to evaluate renal response in future LN trials."
About AURION
The AURION study or "Aurinia Early
Urinary Protein Reduction Predicts Response Study" is an open-label,
exploratory study being conducted in 10 patients in two sites in
Malaysia to assess the short-term predictors of response using
voclosporin (23.7 mg) in combination with mycophenolate mofetil and oral
corticosteroids in patients with active lupus nephritis. This study will
examine biomarkers of disease activity at eight weeks and their ability to
predict response at 24 and 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 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 is 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 and tissue systems. It is estimated that as many as
60 per cent 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 Pharmaceuticals Inc.
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.
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