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 two late-breaking abstracts for voclosporin were accepted for oral presentations at the ACR/ARHP Annual Meeting taking place in Washington, D.C. November 11-16, 2016, and ASN Kidney Week taking place in Chicago November 15-20, 2016.
“The selection of voclosporin data for two late-breaking oral presentations at key medical meetings underscores the importance of providing the medical community with new information about therapy advancements in the treatment of lupus nephritis,” said Neil Solomons, M.D., Aurinia’s Chief Medical Officer. “Data presented highlights Aurinia’s commitment to providing lupus nephritis patients with a tolerable and effective treatment option, improving long-term patient outcomes and quality of life.”
The schedule for the oral presentations is as follows:
Session: Late-Breaking Oral Abstracts
Speed of
Remission with the Use of Voclosporin, MMF & Low Dose Steroids: Results
of a Global Lupus Nephritis Study
Conference: 2016 ACR/ARHP
Annual Meeting
Date/Time: November 15, 2016, 4:30-6:00 p.m.
Presented
by: Mary Anne Dooley, M.D., M.P.H., Adjunct Professor of Medicine,
University of North Carolina Kidney Center
Presentation Number: 5L
Session: High Impact Clinical Trials
AURA-LV:
Successful Treatment of Active Lupus Nephritis with Voclosporin
Conference:
ASN Kidney Week 2016 Annual Meeting
Date/Time: November 19, 11:50
a.m.
Presented by: William Pendergraft, M.D., Ph.D., Assistant
Professor of Medicine in the Division of Nephrology & Hypertension at
the University of North Carolina
Abstract Number: 6480
About AURA-LV
The AURA–LV study (Aurinia Urine
protein Reduction in Active Lupus with Voclosporin) compared the
efficacy of two doses of voclosporin added to current standard of care
of mycophenolate mofetil (MMF, also known as CellCept®) against standard
of care with placebo in achieving complete remission (CR) in patients
with active LN. All arms also received low doses of corticosteroids as
background therapy. 265 patients were enrolled at centers in over 20
countries worldwide. On entry to the study, patients were required to
have a diagnosis of LN according to established diagnostic criteria
(American College of Rheumatology) and clinical and biopsy features
indicative of highly active nephritis.
About Voclosporin
Voclosporin, an investigational
drug, is a novel and potentially best-in-class calcineurin inhibitor
(“CNI”) with clinical data in over 2,000 patients in other 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)
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 measures 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, 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 lupus nephritis (LN). The company is headquartered in
Victoria, BC. Canada and focuses its development efforts globally. www.auriniapharma.com.
Forward Looking Statements
This press release
contains forward-looking statements, including statements Aurinia's
analysis, assessment and conclusions of the results of the AURA-LV
clinical study, 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 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, 2015
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.
