Aurinia Initiates First Clinical Study of Voclosporin for Japan
09 May 2016 - 12:00PM
Business Wire
Study has potential to reduce Japanese
development timelines
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 practical.”
About Aurinia
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.
About voclosporin
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.
About AURA
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
non-renal SLE.
We seek Safe Harbor.
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Aurinia Pharmaceuticals Inc.Mr. Michael Martin,
250-708-4272Chief Operating
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514-939-3989