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news.Aurinia Pharmaceuticals has unveiled its plans for a single phase III clinical trial for voclosporin in the treatment of lupus nephritis (LN).
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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.
Aurinia CEO Charles Rowland said: “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."
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 which includes:
- 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 16-24)
- 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.
Lawrence D. Mandt, Vice President of Quality and Regulatory Affairs at Aurinia, said: "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.
“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 possible.”