Full Press Release Details
Highlights Renal Function Data from Global Phase IIb AURA Study of
Voclosporin for Lupus Nephritis at American Society of Nephrology Kidney
is the first global study of active lupus nephritis to meet primary
function remains stable throughout 24-week treatment period
VICTORIA, British Columbia--(BUSINESS WIRE)--November 21, 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 highlights from its global
Phase IIb AURA study of voclosporin in the treatment of lupus nephritis
(LN) presented at the American Society of Nephrology Kidney Week 2016 on
November 19, 2016. The late-breaking abstract presented in the "High
Impact Clinical Trials Session", titled, "AURA-LV: Successful Treatment
of Active Lupus Nephritis with Voclosporin," was presented by principal
investigator William Pendergraft, M.D., Ph.D., University of North
Carolina Kidney Center.
"There is a critical unmet need for an effective therapeutic treatment
of LN, a devastating and life-altering disease that, if left untreated,
can lead to end-stage renal disease and even death," said Dr.
Pendergraft. "Until now, the LN clinical trial landscape has been bleak,
but AURA is now the first global study in active LN to meet its primary
endpoint and all pre-specified secondary endpoints. Voclosporin 23.7mg
BID doubled the odds of patients reaching CR in the presence of very low
corticosteroid exposure, and maintained normal, stable renal function.
Renal function in active LN patients is often erratic, causing concern
for clinicians and patients. The observation that renal function in
voclosporin-treated patients remained stable throughout the study period
is extremely encouraging. Based on the favorable results of the AURA
study, I believe voclosporin will help patients who are impacted by this
The AURA study enrolled 265 patients in 20 countries using low dose
(23.7 mg BID) voclosporin, 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 CR 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 (SLEDA)I score; and
reduction in UPCR over the 24-week treatment period. In the voclosporin
arms, the renal function as measured by eGFR was stable and not
significantly different from the control arm during the course of the
trial. Mean blood pressure was slightly reduced and was similar between
all treatment groups. Adverse events occurred in both voclosporin groups
(25.8% low, 25.0% high, 15.8% placebo) with the nature of adverse events
consistent with those observed in patients with highly active LN and
increased immunomodulation. The AURA study remains ongoing until its
48-week secondary endpoints, which will be completed in Q1 2017.
"The nephrology community's positive reception to the AURA data is
encouraging as we prepare to initiate our single Phase III clinical
trial of voclosporin in Q2 2017," said Neil Solomons, M.D., Aurinia's
Chief Medical Officer. "We remain committed to progressing this
important therapy to market and believe it has the potential to change
the paradigm of care for patients living with LN, significantly
improving long-term outcomes and quality of life."
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
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