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.
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:
25% Reduction in urine protein creatinine ratio (UPCR) from baseline to week 8 is highly predictive of renal response at 24 & 48 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; furthermore, the trial met all key pre-specified secondary endpoints
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.
23.7mg BID of voclosporin demonstrated statistical significance across multiple efficacy measures vs the control group:
Primary Outcome Measure:
- Higher complete remission (CR), or renal response at 24 weeks
Key Secondary Outcome Measures:
- Higher complete remission rates at weeks 24 and 48
- Higher partial remission rates (50% reduction in UPCR over baseline) at weeks 24 and 48
- Faster speed of remission
- Reduction in UPCR (both FMV & 24hr urine) at weeks 24 and 48
- Reduction in SLEDAI score at weeks 24 and 48
No new safety signals were observed with the use of voclosporin in LN patients; voclosporin was well-tolerated and the overall safety profile is consistent with other immunomodulating therapies.
We have initiated a single, Phase III global placebo-controlled clinical trial to assess voclosporin for the treatment of active lupus nephritis. This study is currently recruiting patients.