Full Press Release Details
Announces Plans for Single Phase III Clinical Trial for Voclosporin in
the Treatment of Lupus Nephritis Following Successful Completion of End
of Phase II Meeting With FDA
23.7mg BID to advance into double-blind placebo controlled Phase III
Phase III study design consistent with AURA
expected to commence in Q2 2017
Call and webcast at 8:30am ET tomorrow
VICTORIA, British Columbia--(BUSINESS WIRE)--November 2, 2016--Aurinia
Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) ("Aurinia" or the
"Company"), today announced its plans for a single Phase III clinical
trial for voclosporin in the treatment of lupus nephritis (LN). Pursuant
to its recent End of Phase II meeting with the U.S. Food & Drug
Administration (FDA) Division of Pulmonary, Allergy and Rheumatology
Products, Aurinia believes this Phase III clinical trial whose design is
consistent with the ongoing AURA study, will support a New Drug
Application (NDA) submission.
"We are thrilled with the outcome and direction received from the FDA.
With a clear path forward for voclosporin's development to treat LN, we
are mobilizing quickly to initiate the Phase III study in Q2 next year,
fulfilling our goal of improving the long-term outcomes for patients
with this disease," added Charles Rowland, Aurinia's Chief Executive
The Phase III AURORA trial will be a global 52-week double-blind,
placebo controlled study of approximately 320 patients. The Company is
finalizing the study protocol and regulatory submissions and in parallel
is working on site selection with trial initiation anticipated in Q2
2017. Patients will be randomized 1:1: to either of 23.7mg voclosporin
BID and MMF or MMF and placebo, with both arms receiving a stringent
oral corticosteroid taper. The study population will be comprised of
patients with biopsy-proven active LN who will be evaluated on the
primary efficacy endpoint of renal response at 24 weeks, a composite
Urinary/protein creatinine ratio (UPCR) of 0.7mg/mg
Normal, stable renal function ( 60 mL/min/1.73m2 or
no confirmed decrease from baseline in eGFR of >20%)
Presence of sustained, low dose steroids ( 10mg prednisone from week
No administration of rescue medications
The readout of the primary endpoint of renal response at 24 weeks will
occur after database lock at 52 weeks at which point the Company intends
to submit an NDA. Patients completing the 52-week study will then have
the option to roll-over into a 104 week blinded continuation study.
These data will allow the Company to assess long-term outcomes in LN
patients that will be valuable in a post-marketing setting in addition
to future interactions with various regulatory authorities.
While voclosporin has received fast track designation, the FDA has
informed the Company that voclosporin is not eligible for breakthrough
therapy designation at this time. Aurinia will continue to benefit from
its fast track designation which includes more frequent communications
with the FDA and potential for priority review and an option to submit a
rolling NDA submission, which may expedite the review process.
"We have shared a substantial amount of efficacy and safety data with
the FDA and are confident in our ability to execute a successful Phase
III clinical trial based on their feedback and the information gleaned
from the AURA study", said Lawrence D. Mandt, Vice President of Quality
and Regulatory Affairs at Aurinia. "We remain committed to addressing
the unmet needs of patients living with LN, a devastating disease, and
look forward to making this product available to patients as soon as
Conference Call and Webcast Details
conference call and webcast tomorrow, November 3, 2016 at 8:30a.m.
Eastern Daylight Time to provide a clinical and regulatory update on
voclosporin. 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.
The AURORA study is a 52-week global
double-blind placebo controlled phase III study that will compare the
efficacy of one dose of voclosporin (23.7mg BID) or placebo added to
current standard of care of mycophenolate mofetil (MMF, also known as
CellCept ) in achieving renal response (formerly referred to as complete
remission) in patients with active LN. Both arms will also receive low
doses of corticosteroids as part of background therapy after a stringent
The AURA-LV study (Aurinia Urinary
protein Reduction in Active Lupus with Voclosporin) is a 48-week study
comparing the efficacy of two doses of voclosporin added to current
standard of care of MMF against standard of care with placebo in
achieving complete remission (CR) in patients with active LN. All arms
also received low doses of corticosteroids as background therapy. 265
patients were enrolled at centers in 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. The
24-week primary and secondary endpoints were released in Q3 2016 with
48-week results to be announced in Q1 2017. The 24-week data have been
accepted for late-breaking presentations at the American College of
Rheumatology (ACR) and American Society of Nephrology (ASN).
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
About Lupus Nephritis (LN)