|Candidate & Indication||Development Stage|
|Preclinical||Phase 1||Phase 2||Phase 3||Market|
|Voclosporin Lupus Nephritis (LN)||
Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase complete
Phase 3 Phase in progress
Market Phase not started
Aurinia is committed to working in areas of high unmet medical need and is poised to potentially deliver the first approved therapy in the U.S. and Europe for the treatment of lupus nephritis, or LN.
The Voclosporin Advantage
Voclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor (“CNI”) with clinical data in over 2,200 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 lupus nephritis (LN) when added to standard of care mycophenolate mofetil (MMF). It has been granted “fast track status” by the U.S. Food & Drug Administration (FDA).
Voclosporin Could Transform the LN treatment Landscape
Voclosporin has the potential to become a best in class medication and the first approved treatment for LN in the U.S. and Europe, effectively altering the current treatment paradigm for the disease.
Advantages of Voclosporin Combined with Standard of Care (SoC)
Our Phase II clinical data suggests that adding voclosporin to the current SoC of MMF for the treatment of lupus nephritis (LN) can yield superior results to using the standard of care alone.
Additionally, voclosporin may prove to be an ideal therapy for lupus nephritis due to advantages such as:
- Improved efficacy
- Increased safety
- Oral administration
- Improved average time to renal response or remission
- Improved duration of renal response
- Reduction in steroid burden
- Potential first line add-on to MMF
- Fewer toxic immunosuppressants required
Potential Benefits of Voclosporin
In clinical trials, Voclosporin has been shown to be especially effective in the presence of low dose steroids with rapid reduction of LN inflammatory markers and overall improved renal stability.
The list of potential product benefits includes:
|LN Critical Need||Voclosporin* (based on AURA Results)|
|Control of Active Disease|
|Rapid Disease Control|
|Lower Steroid Burden|
|Impact on Extra-renal disease|
|Convenient Treatment Regimen|
*Based on AURA Results
In previous studies, over 2000 patients have been treated with Voclosporin with no abnormal or unexpected SAE’s
Well Characterized Safety Profile
Efficacy of calcineurin inhibition has already been established. Voclosporin has a well-characterized safety profile (over 2,200 patient exposures across multiple years) across indications.
No new safety signals were observed with the use of Voclosporin in LN patients; Voclosporin was well-tolerated and renal function remained stable in clinical studies. The overall safety profile is consistent with other immunosuppressive drugs.