Voclosporin Clinical Data shows Potential to alter Long-Term Outcomes in LN
Voclosporin has a synergistic, dual mechanism of action that has the potential to improve near and long-term outcomes in patients with LN when added to the current standard of care (SoC) of mycophenolate mofetil (MMF) treatment.
Clinical trials to date have demonstrated the potential of voclosporin to increase both speed and rates of remission (or renal response) in patients with LN when added to MMF and in the presence of low-doses of oral corticosteroids.
Ongoing Clinical Trials
AURION - Aurinia Early Urinary Protein Reduction Predicts Response
AURION is an exploratory study assessing the short term predictors of remission of Voclosporin 23.7mg BID in combination with standard of care in patients with active lupus nephritis. Patients were evaluated at the exploratory endpoint (8 weeks), then again at 24 weeks and at the end of the study, at 48 weeks.
The results to date have demonstrated the following:
- Complete Remission (renal response) rates improve over time:
- 50% at 8 weeks
- 70% at 24 weeks
- Voclosporin (23.7 BID) is the optimal dose for phase III program
- Renal function improves and inflammatory markers continue to normalize
- AURION is a supportive proof of concept study
AURA-LV - Aurinia Early Urinary Protein Reduction Predicts Response
AURA is the first global clinical trial in active LN to meet its primary endpoint
AURA-LV (AURA) is global placebo controlled Phase IIb study that aims to demonstrate that voclosporin added to SoC can increase speed of remission & overall remission rates in the presence of extremely low steroids.
The primary endpoint data were released in August and September 2016. AURA is the first global clinical trial in active lupus nephritis to meet its primary endpoint. In addition, the trial met all of its secondary endpoints at 24 weeks. The study remains ongoing to its 48-week secondary endpoint where data will be available in Q1 2017.
23.7mg BID of voclosporin demonstrated statistical significance across all efficacy measures:
Primary Outcome Measure:
- Higher complete remission (CR), or renal response (p=.045)
Secondary Outcome Measures:
- Higher partial remission, or partial renal response (PR) (p=.007)
- Faster time to CR, or renal response (p=.007)
- Faster time to PR, or partial renal response (p=.001)
- Reduction in UPCR (p=.<01)
- Reduction in SLEDAI score (p=.003)
Voclosporin has shown efficacy across multiple dimensions
AURORA - Phase III Clinical Trial
We will be initiating a single, Phase 3 global placebo-controlled clinical trial to assess voclosporin for the treatment of active lupus nephritis in early 2017.
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