Mr. Richard Glickman reports
AURINIA ANNOUNCES DEVELOPMENT PLANS FOR VOCLOSPORIN IN EUROPE AND JAPAN
Aurinia Pharmaceuticals Inc. is providing the outcome of discussions with both the
European Medicines Agency (EMA) and the Pharmaceutical and Medical
Devices Agency (PMDA) in Japan regarding the development of voclosporin
for the treatment of active lupus nephritis (LN). Pursuant to these
discussions, the company believes that the confirmatory data that can be
generated from the single phase III clinical trial (Aurora) and the
recently completed Aura-LV (Aura) phase IIb study should support
regulatory submissions in the United States, Europe and Japan.
"Our interactions with regulators in all three jurisdictions have given
us a clear pathway for phase III, and we are confident in our ability to
execute Aurora successfully 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. "The productive conclusion of
these regulatory interactions marks a milestone in our development
program and brings this exciting new therapeutic option one step closer
to those patients suffering from LN."
The phase III Aurora trial will be a global 52-week double-blind,
placebo-controlled study of approximately 320 patients. Patients will be
randomized 1:1: to either of 23.7 milligram voclosporin BID and mycophenolate
mofetil (MMF) or MMF and placebo, with both arms receiving a stringent
oral corticosteroid taper. As in Aura, the study population will be composed of patients with biopsy-proven active LN who will be evaluated
on the primary efficacy end point of complete remission, or renal
response, at 52 weeks, a composite which includes:
-
Urinary/protein creatinine ratio (UPCR) of (equals) 0.5 mg/mg;
-
Normal, stable renal function ((equals) 60 millilitre/min/1.73 square metre or no
confirmed decrease from baseline in eGFR of greater than 20 per cent);
-
Presence of sustained, low-dose steroids ((equals) 10 mg prednisone from week
16 through 24);
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No administration of rescue medications.
"Based on the recent learnings from the positive AURA study at 48 weeks,
we intend to use a UPCR of (equals) 0.5 mg/mg and evaluate the primary endpoint
at 52 weeks in Aurora," added Richard M. Glickman, Aurinia's chief
executive officer. "We are on track to initiating the global Aurora
study this quarter and fulfilling our goal of improving the long-term
outcomes for patients with this disease."
About Aurinia Pharmaceuticals Inc.
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 LN.
We seek Safe Harbor.
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