Full Press Release Details
Pharmaceuticals to Host Lupus Nephritis (LN) Breakfast and Webcast on
detailed results from the Phase 2b AURA-LV study in patients with active
VICTORIA, British Columbia--(BUSINESS WIRE)--September 21, 2016--Aurinia
Pharmaceuticals Inc., (NASDAQ:AUPH;TSX:AUP) today announced that it will
host a Lupus Nephritis (LN) expert breakfast on Friday, September 30th
from 8:00am to 9:30am EDT in New York.
The Company will review the recently released top-line results from the
AURA-LV Phase 2b study in patients with active LN and announce
additional data, including pre-specified analyses, secondary endpoints,
and additional subset analyses.
The meeting will also feature a discussion by renowned nephrologists
David R.W. Jayne, MD, Director of the Vasculitis and Lupus Clinic at
University of Cambridge, and William Pendergraft III, MD, PhD, Assistant
Professor of Medicine in the Division of Nephrology & Hypertension at
the UNC School of Medicine, on the current standard of care for LN and
how voclosporin can shape the future treatment paradigm for this disease
of high unmet medical need.
The event is intended for investors, sell-side analysts, and business
development professionals only. Please RSVP in advance if you plan to
attend, as space is limited. To reserve a spot, please contact LifeSci
Advisors, LLC at mac@lifesciadvisors.com. A live webcast of the
event, with slides, will be available on the Investors section of the
Company's website at http://www.auriniapharma.com/dnn/ForInvestors/Webcasts.aspx.
The AURA-LV study or "Aurinia Urine Protein Reduction in Active Lupus
Nephritis Study" compared the efficacy 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. Both arms also received low doses of
corticosteroids as background therapy. It enrolled 265 patients 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 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 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.
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 headquartered in Victoria, BC and focuses
its development efforts globally.
Visit www.auriniapharma.com for more information.