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Aurinia Pharmaceuticals: Phase III Design Gleaned From Phase II Study

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  • Aurinia Pharmaceuticals' Phase III (AURORA) design is nearly identical to the promising Phase II (AURA) study.
  • Advantageous change to Phase III includes: Primary endpoint of complete remission (or renal response) at 52 weeks (as opposed to 24 weeks in Phase II).
  • Management team will likely enroll healthier patients and limit countries (e.g., Bangladesh and Philippines) with compromised access to medical care.

Problem: Patients are suffering

Aurinia Pharmaceuticals (NASDAQ:AUPH) is a late-stage biopharmaceutical company that specializes in the development of voclosporin, a novel in-class calcineurin inhibitor, for the treatment of lupus nephritis (LN). According to the Lupus Research Alliance, lupus nephritis is a debilitating, autoimmune disease that causes inflammation of a patient's kidney. Mok et al's research (2013, DOI: 10.1002/art.38006) titled "Effect of Renal Disease on the Standardized Mortality Ratio and Life Expectancy of Patients With Systemic Lupus Erythematosus" showed that up to 60% of lupus patients will develop LN. Lupus patient with end-stage renal disease (ESRD) have a 60-fold increase of death, which highlights acutely on the importance to prevent LN patients from getting into the damaged kidney phase. Moreover, 10-30% of proliferate LN (stage III and IV) patients will develop ESRD. In severe cases, patients may need dialysis when both of their kidneys fail, prompting them to use a machine to remove toxic waste from the body.

The current standard of care is insufficient in treating LN, and a better treatment is urgently needed. At the moment, most physicians will prescribe mycophenolate mofetil (MMF) or better known as CellCept®, an immunosuppressive drug. CellCept's original purpose is to help suppress the body from rejecting a new organ transplant. Thus, this drug is being used as an off-label to treat LN. You can read more about CellCept here. Corticosteroids may be used in addition to help decrease inflammation in an LN patient.

Solution: Voclosporin ready to prove effectiveness in upcoming favorable Phase III trial

Phase II (AURA) randomized 265 patients into a 1:1:1 ratio for the three arms (control, low-dose voclosporin, and high-dose voclosporin). Study's key inclusion criteria took patients with Urine Protein to Creatinine Ratio (UPCR)>1.5mg/mg (class III, IV) or > 2mg/mg (class V). You can learn more about Phase II trial design and successful outcome

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