VICTORIA, British Columbia--(BUSINESS WIRE)--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 the first patient has been dosed in AURORA, the Company’s Phase 3 confirmatory clinical trial evaluating voclosporin for the treatment of lupus nephritis (LN), an autoimmune disease caused by lupus that involves extreme inflammation and failure of the kidneys.
“Dosing our first patient today is an important milestone for the Company,” said Neil Solomons, M.D., Chief Medical Officer of Aurinia. “Our Phase 3 trial design is nearly identical to that of our successful Phase 2 AURA trial which demonstrated the potential of voclosporin to increase both speed and rates of remission in patients with active LN. We remain dedicated to advancing this treatment and making a meaningful impact in the lives of patients suffering from LN and those around them.”
AURORA is a 52-week global double-blind placebo controlled study, designed to demonstrate that voclosporin added to the current standard of care of mycophenolate mofetil (MMF) can increase overall renal response rates in the presence of extremely low steroids. The primary endpoint is complete renal response at 52 weeks. This trial will recruit ~320 patients and is intended to support full marketing approval of voclosporin for patients with LN across multiple regulatory jurisdictions.
“Lupus nephritis is a devastating disease which if not managed, can be life-threatening. There is no approved medication to treat the condition which mostly affects women in their childbearing years,” said Mary Anne Dooley, M.D., M.P.H., Adjunct Professor of Medicine at University of North Carolina School of Medicine and principal investigator for the study. “The AURA Phase II results showed great promise and if replicated in Phase 3, voclosporin has the potential to change the current treatment paradigm for LN.”
About AURORA
The AURORA study is a 52-week global
double-blind placebo controlled Phase 3 study that will compare the
efficacy of one dose of voclosporin (23.7mg BID) to placebo when 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. For further questions on the trial or interest in participating,
please see our website (http://www.auriniapharma.com/for-patients-physicians/clinical-trials)
or contact us at clinicaltrials@auriniapharma.com.
About Voclosporin
Voclosporin, an investigational
drug, is a novel and potentially best-in-class calcineurin inhibitor
(“CNI”) with clinical trial 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. Voclosporin is made by a modification of a
single amino acid of the cyclosporine molecule which results in a more
predictable pharmacokinetic and pharmacodynamic relationship with
potential for flat dosing. In addition, Voclosporin is more potent than
and has an improved metabolic profile versus cyclosporine. 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, an inflammation of the
kidney caused by Systemic Lupus Erythematosus (“SLE”), represents a
serious progression of SLE. SLE is a chronic, complex and often
disabling disorder that 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 a strong surrogate marker, proteinuria, which correlates
with meaningful longer term clinical outcome. 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 potentially shifting the treatment paradigm for LN. 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, 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.
