Full Press Release Details
Selects Worldwide Clinical Trials as its CRO for Phase 3 Lupus Nephritis
Phase 3 Trial on track to commence in Q2 2017
VICTORIA, British Columbia--(BUSINESS WIRE)--January 27, 2017--Aurinia
Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) ("Aurinia" or the
"Company"), a clinical stage biopharmaceutical company focused on the
global immunology market, today announced that it has selected Worldwide
Clinical Trials ("Worldwide") as its Clinical Research Organization
(CRO) for the AURORA Phase 3 study of volcosporin for the treatment of
active lupus nephritis (LN).
"Selecting a CRO for AURORA is a key milestone for Aurinia following our
successful end-of-Phase 2 meeting with the U.S. Food & Drug
Administration (FDA) Division of Pulmonary, Allergy and Rheumatology
Products. We are thrilled to partner with Worldwide to support the
AURORA Phase 3 clinical trial," said Charles Rowland, Chief Executive
Officer of Aurinia. "We are rapidly moving forward with our plans to
bring this important therapy to market for patients living with this
devastating disease, and Worldwide's deep expertise and capabilities in
managing pivotal trials will be a tremendous asset to us. We are on
track to commence the AURORA trial in the second quarter of 2017, and we
expect the results from this study will support a New Drug Application
(NDA) submission to the FDA."
With support from Worldwide, Aurinia will proceed with conducting a
randomized, placebo-controlled, double-blind global 52-week trial in
approximately 320 patients. The primary endpoint as in the Phase 2b AURA
trial is renal response (complete remission), at 24 weeks. In addition
to the assessment of renal response, a key marker of clinical benefit in
this population is the duration of proteinuria improvement. Therefore,
secondary endpoints will include the duration of renal response at 52
weeks (48 weeks in AURA), an efficacy measure which delineates
durability of renal response (remission), an important parameter in
evaluating long-term outcomes for the treatment of LN.
"Our entire Worldwide team is delighted to have been selected as
Aurinia's CRO partner to advance voclosporin, which has the potential to
become the first FDA-approved treatment for LN," said Peter Benton,
President and Chief Operating Officer at Worldwide Clinical Trials.
"We're truly honored that an innovator like Aurinia recognizes what
Worldwide brings to the table: medical and scientific expertise,
proactive insight, dogged determination, rigorous processes and a
commitment to getting it right. We're looking forward to working closely
with Aurinia's clinical development team on this new therapy, which
could significantly improve the lives and long-term outcomes of patients
Voclosporin, an investigational drug, is a novel and potentially
best-in-class calcineurin inhibitor ("CNI") with clinical data in over
2,000 patients across 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 other countries.
About Lupus Nephritis (LN)
Lupus Nephritis (LN) in an inflammation of the kidney caused by Systemic
Lupus Erythematosus (SLE) and represents a serious progression of SLE.
SLE is a chronic, complex and often disabling disorder and affects more
than 500,000 people in the United States (mostly women). The disease is
highly heterogeneous, affecting a wide range of organs & tissue systems.
It is estimated that as many as 60% of all SLE patients have clinical LN
requiring treatment. Unlike SLE, LN has straightforward disease outcomes
where an early response correlates with long-term outcomes, measured by
proteinuria. In patients with LN, renal damage results in proteinuria
and/or hematuria and a decrease in renal function as evidenced by
reduced estimated glomerular filtration rate (eGFR), and increased serum
creatinine levels. LN is debilitating and costly and if poorly
controlled, LN can lead to permanent and irreversible tissue damage
within the kidney, resulting in end-stage renal disease (ESRD), thus
making LN a serious and potentially life-threatening condition.
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 taper. Aurinia believes
this Phase III clinical trial whose design is consistent with the
ongoing AURA study, will support a New Drug Application (NDA) submission.
Aurinia is a clinical stage biopharmaceutical company focused on
developing and commercializing therapies to treat targeted patient
populations that are suffering from serious diseases with a high unmet
medical need. The company is currently developing voclosporin, an
investigational drug, for the treatment of lupus nephritis (LN). The
company is headquartered in Victoria, BC and focuses its development
efforts globally. www.auriniapharma.com.
About Worldwide Clinical Trials
Worldwide Clinical Trials employs more than 1,400 professionals around
the world, with offices in North and South America, Eastern and Western
Europe, Russia and Asia. One of the world's leading, full-service
contract research organizations (CROs), we partner with sponsors in the
pharmaceutical and biotechnology industries to deliver fully integrated
clinical development and bioanalytical services, extending from
first-in-human through phase IV studies. Grounded in medicine and
science, we help sponsors move from discovery into clinical development
and commercialization across a range of therapeutic areas, including
neuroscience, cardiovascular diseases, immune-mediated inflammatory
disorders (IMID), and rare diseases. For more information, visit www.Worldwide.com.