Full Press Release Details
Pharmaceuticals Announces Voclosporin Meets Primary Endpoint in Phase
Study in Lupus Nephritis
call and webcast at 8am ET
therapeutic agent to meet primary endpoint in a global clinical trial
for active lupus nephritis (LN)
shown to have statistically significant improvement in both complete
and partial remission in the presence of forced steroid taper
VICTORIA, British Columbia--(BUSINESS WIRE)--August 15, 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 positive top-line results from
the Phase 2b AURA-LV (AURA) clinical study in patients with active lupus
nephritis (LN). The trial achieved its primary endpoint, demonstrating
statistically significantly greater complete remission (CR) (as defined
by confirmed urinary protein/creatinine ratio of 0.5 mg/mg at 24 weeks
and confirmed at 26 weeks) in patients treated with 23.7 mg of
voclosporin twice daily (p=0.045). Both treatment arms, 23.7 mg and 35.9
mg twice daily also showed a statistically significant improvement in
the rate of achieving partial remission (PR) at 24 weeks (p=0.007;
p=0.024). Each arm of the study included the current standard of care of
mycophenolate mofetil (MMF) as background therapy and a forced steroid
taper to 5 mg/day by week 8 and 2.5 mg by week 16. No unexpected safety
signals were observed and voclosporin was shown to be well tolerated.
"We are very pleased by these encouraging results and are grateful to
those that participated in our clinical trials," said Neil Solomons,
M.D., Aurinia's Chief Medical Officer. "The AURA study was conducted
under rigorous and stringent criteria, enhancing our confidence in
voclosporin's potential ability to provide a substantial improvement
over the currently accepted standard of care, especially given that
study participants had such active disease and were exposed to such a
low corticosteroid load. We continue to work diligently towards our goal
of improving long-term outcomes for these patients."
Based on the results of the 24-week analysis, Aurinia plans to meet with
the U.S. Food and Drug Administration in the fourth quarter of 2016 to
discuss these data and the drug's subsequent clinical development and
path to registration in LN. Further analyses of the data will also be
conducted and will be released later this year. Additionally, the
Company plans to submit the results for presentation at a major medical
meeting in the near future. The study will continue through 48 weeks,
and these data will be available for release in early 2017.
Mary Anne Dooley, M.D., a rheumatologist, LN expert and Chief
Investigator on the study, stated "These preliminary results show
great promise and could potentially change the current treatment
paradigm for LN. The remission rates show a meaningful improvement over
the current standard of care. Achieving this result given the taper
to low dose steroids represents a significant advance. Given the side
effects of corticosteroids, limiting the dose could substantially
enhance a patient's quality of life."
"The results of this trial are welcomed and exciting news for people
with lupus and their doctors who are eager to have more tolerable and
effective treatments options," said Sandra. C. Raymond, President and
Chief Executive Officer of the Lupus Foundation of America. "Lupus
kidney disease (lupus nephritis) is one of the most serious and
potentially life-threatening complications of this autoimmune disease,
affecting as many as 60 percent of people with lupus. This trial
of voclosporin along with standard of care is the first trial of a
potential treatment for active lupus nephritis to reach its primary
endpoint, offering hope to individuals with lupus kidney disease. We
look forward to the timely commencement of a Phase 3 trial; and, should
the findings confirm this study, the addition of this regimen to the
arsenal of treatments available to people who have waited far too long
for medicines that improve the quality of their lives."
Conference Call and Webcast Details
Aurinia will host a conference call and webcast today, August 15, 2016
at 8:00 a.m. Eastern Daylight Time to discuss the AURA-LV study results.
In order to participate in the conference call, please dial
+1-877-407-9170 (Toll-free US & Canada). An audio webcast can be
accessed under "Webcasts" through the "Investors" section of the Aurinia
corporate website at www.auriniapharma.com. A replay of the
webcast will be available on Aurinia's website for 45 days.
AURA-LV Trial Design
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. 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.
Patients were randomized to one of two dosage groups of voclosporin
(23.7 mg BID and 39.5 mg BID) or placebo, with all patients also
receiving mycophenolate mofetil and oral corticosteroids as background
therapy. All patients had an initial IV dose of steroids (500-1000 mg)
and then were started on 20-25 mg/daily, which was tapered down to a low
dose of 5 mg daily by week 8 and 2.5 mg daily by week 16.
The primary endpoint was a measure of the number of patients who
achieved CR at 24 weeks (confirmed at 26 weeks); CR was defined as a
protein/creatinine ratio of 0.5 mg/mg as well as normal stable renal
function (eGFR 60 mL/min/1.73m2 or no confirmed
decrease from baseline in eGFR of 20%.).
Secondary endpoints included durability of remission, CR as per the
primary analysis at 48-weeks and extra-renal lupus activity (SLEDAI),
which will be evaluated and reported at a later date.
The groups were generally well-balanced for age, gender and race,
however when considered together, the proteinuria and GFR data suggest
that disease severity was greater for the low-dose voclosporin group.
The primary endpoint of CR was met for the low-dose voclosporin group
in the ITT analysis (p=0.045). 32.6% of patients on low dose achieved
CR, compared to 27.3% on high dose and 19.3% in the control arm.