Full Press Release Details
Initiates First Clinical Study of Voclosporin for Japan
potential to reduce Japanese development timelines
VICTORIA, British Columbia--(BUSINESS WIRE)--May 9, 2016--Aurinia
Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) ("Aurinia" or the
"Company") announced today that after constructive interactions with the
Japanese Pharmaceuticals and Medical Devices Agency ("PMDA"), the
Company will initiate a study of voclosporin in healthy Japanese
volunteers. With positive results from the pending Phase 2b AURA-LV
study in lupus nephritis ("LN") and supportive safety, tolerability,
pharmacokinetic and pharmacodynamic data from this clinical study, the
Company hopes to be able to incorporate Japanese patients into future
global voclosporin studies, eliminating the need to conduct a
stand-alone Japanese trial.
"Japan represents a substantial market opportunity for the Company" said
Charlie Rowland, CEO of Aurinia Pharmaceuticals Inc. "This Japanese
study has the potential to reduce development timelines for voclosporin
in this major market. With voclosporin's product attributes, we're
confident that we may be able to offer Japanese patients suffering from
LN a more suitable treatment approach compared to the current therapies."
"Our interactions with the PMDA to date have been beneficial" stated
Lawrence Mandt, Vice President of Regulatory and Quality for the
Company. "We're looking forward to continued productive discussions in
order to bring voclosporin to Japanese LN patients as quickly as is
Aurinia is a clinical stage pharmaceutical company focused on the global
nephrology market. The fully-enrolled Phase 2b AURA-LV clinical trial is
evaluating the efficacy of its lead drug, voclosporin, as a treatment
for active LN. LN is an inflammation of the kidneys, that if
inadequately treated can lead to end-stage renal disease, making LN a
serious and potentially life-threatening condition.
Voclosporin is a novel and potentially best-in-class calcineurin
inhibitor ("CNI") with extensive clinical data in over 2,000 patients in
other indications. Voclosporin is made by a modification of a single
amino acid of the cyclosporine molecule (a CNI approved for use in
transplant patients since 1983). This modification results in a more
predictable pharmacokinetic and pharmacodynamic relationship, an
increase in potency vs. cyclosporine, an altered metabolic profile, and
potential for flat dosing.
The AURA-LV study or "Aurinia Urine Protein Reduction in Active Lupus
Nephritis Study" is an adequate and well-controlled clinical trial that
enrolled 265 patients and is being conducted in over 20 countries
worldwide. This trial will compare the efficacy of voclosporin against
placebo in achieving remission in patients with active lupus nephritis.
The AURA-LV study is designed to demonstrate that voclosporin can induce
a rapid and sustained reduction of proteinuria in the presence of
extremely low steroid exposure. It will compare two dosage groups of
voclosporin (23.7mg and 39.5mg) compared to placebo, with all patients
receiving mycophenolate mofetil (MMF) and oral corticosteroids as
background therapy. There will be a primary analysis to determine
complete remission at week 24 (confirmed at 26 weeks) and various
secondary analyses at week 48 which include biomarkers and markers of
We seek Safe Harbor.
Aurinia Pharmaceuticals Inc.
Chief Operating Officer
Financial Communications Inc.
Tel: 416-644-2020 or