Full Press Release Details
Announces Result from Data and Safety Monitoring Board for Its Phase 2b
Study in Lupus Nephritis - Study to Continue as Planned
VICTORIA, British Columbia--(BUSINESS WIRE)--March 29, 2016--Aurinia
Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) ("Aurinia" or the
"Company") has announced today that the independent Data and Safety
Monitoring Board (DSMB) for the Company's Phase 2b clinical study known
as AURA has completed the fourth and final pre-specified safety review
prior to the release of the primary endpoint data, which is expected in
the third quarter of 2016. After review of available safety data, the
DSMB has again recommended that the study continue as planned without
any modifications. The AURA DSMB has been established according to the
FDA Guidance for Clinical Trial Sponsors and is guided by its charter.
Aurinia remains blinded to the actual safety and efficacy results.
The committee reviewed available safety data from all 265 patients
randomized into the study and treated for a minimum of one month. Many
of these patients have already been treated up to and beyond the 24 week
primary endpoint, and some have been treated for the full study period
"We are encouraged by the consistent recommendations of the DSMB." said
Neil Solomons, M.D., Chief Medical Officer of Aurinia. "We look forward
to assessing the risk-benefit of multi-target therapy utilizing
voclosporin when reviewing the primary endpoint and key 24 week efficacy
and safety data in the third quarter of this year."
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 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.
(250) 744-2498 (fax)
Financial Communications Inc.
Barry Mire: bmire@renmarkfinancial.com
Welsh: lwelsh@renmarkfinancial.com
Tel: (416) 644-2020 or