Full Press Release Details
Announces Acceptance of Late-Breaking Voclosporin Abstracts for Oral
Presentation at Upcoming Medical Meetings
to be Presented at the "Late Breaking Session" at the 2016 American
College of Rheumatology/Association of Rheumatology Health
Professionals (ACR/ARHP) Annual Meeting and the "High Impact Clinical
Trials" Session at American Society for Nephrology (ASN) Kidney Week
VICTORIA, British Columbia--(BUSINESS WIRE)--October 24, 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 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
with the Use of Voclosporin, MMF & Low Dose Steroids: Results of a
Global Lupus Nephritis Study
Conference: 2016 ACR/ARHP Annual
Date/Time: November 15, 2016, 4:30-6:00 p.m.
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
Treatment of Active Lupus Nephritis with Voclosporin
ASN Kidney Week 2016 Annual Meeting
Date/Time: November 19, 11:50 a.m.
by: William Pendergraft, M.D., Ph.D., Assistant Professor of Medicine in
the Division of Nephrology & Hypertension at the University of North
Abstract Number: 6480
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.
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
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.
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,