Aurinia Pharmaceuticals, Inc.
Small/Mid Cap Pharmaceuticals: Voclosporin, Lupus Nephritis
Pipeline Potential: A
Pipeline Diversity: F
Pipeline Risk: B
Pipeline Competition: A
Financial Security: A
Aurinia Pharmaceuticals is a late-stage biopharmaceutical company focused on treatment of Lupus Nephritis. Aurinia produces no current licensed pharmaceutical drugs. However, its late-stage drug Voclosporin has shown successful results in Phase I and Phase II clinical trials. Voclosporin is an experimental calcineurin inhibitor used to treat Lupus Nephritis, a condition which affects about 900,000 people in the United States. Aurinia is currently undergoing a Phase III clinical trial, named AURORA, on Voclosporin.
Voclosporin has shown success in its Phase II AURA-LV clinical trials. Phase II results indicated very strong complete remission rates at 24-weeks, surpassing its primary endpoints and a follow-up Phase IIb study demonstrated stronger remission rates at 48-weeks. If AURORA Phase III trials demonstrate as much success as the Phase II trial, Aurinia will use the results to file for a New Drug Application (NDA). Because of Voclosporin’s fast-track designation by the FDA, chances for approval are very high. There is no current treatment approved for therapy of Lupus Nephritis, so Voclosporin has the potential to exclusively treat those with Lupus Nephritis.
Aurinia’s main weakness lies in its lack of a diverse pipeline. Aurinia’s only drug studied is Voclosporin. Therefore, if Phase III trials are unsuccessful, Aurinia will be left with very little to work with. AURORA Phase III trial is a 52-week trial and is aimed to begin in Q2 2017. Therefore, until results are unblinded in 2018, very little news is expected from the company.
Price movement of Aurinia is completely dependent on the results of the AURORA Phase III study. Nevertheless, because of Aurinia’s lack of a diverse pipeline, investing in Aurinia has some risk. However, due to success in Phase II trials and fast-track designation, the risk-to-reward ratio is low compared to other small-cap biopharmaceuticals and remains a good pipeline to hold.
Lupus Nephritis is a subset condition of systemic lupus erythematous, simply known as lupus. Of those with lupus, about 50% of adults will obtain kidney disease and about 80% of children. Lupus patients with renal damage are 14 times more likely suffer premature death, and lupus patients with end-stage renal disease are 60 times more likely to suffer premature death. Aurinia aims to reduce this number by using Voclosporin, a calcineurin-inhibitor, to cause increased remission rates in the general population. Calcineurin is a protein which activates T-cells, a type of white blood cell. In those with Lupus Nephritis, these T-cells attack the kidney causing kidney damage or failure. Currently, other calcineurin-inhibitors such cyclosporine and tacrolimus have been used to mitigate autoimmunity in lupus nephritis patients; however, safety and efficacy is a concern with both of these drugs, and therefore, they have not been approved as treatments for Lupus Nephritis in the United States or European Union. Voclosporin has shown increased remission rates in comparison to these two drugs and a better safety profile making it the likely choice for treatment of lupus nephritis.
Aurinia released results from its AURA-LV phase IIb trials on March 2, 2017. The study contained 3 arms: control, low-dose Voclosporin, high-dose Voclosporin. At 48 weeks, the control group showed 24% of patients with complete remission, the low dose group showed 49% of patients with complete remission (p<0.01), and the high dose group showed 40% of patients with complete remission (p=0.026). There was also a demonstrated increase in complete remission rates from the 24-week endpoint and the 48-week endpoint. The study indicated 0 deaths and malignancies in the low (n=89) and high (n=88) dose groups while the control (n=89) group had 1 malignancy and 3 deaths.
Disclosure: I/we are long AUPH.
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