VICTORIA, BC–Aurinia Pharmaceuticals has chosen Worldwide Clinical Trials as its clinical research organization (CRO) service provider for its upcoming AURORA Phase 3 study of volcosporin to treat active lupus nephritis (LN).
With support from Worldwide, Aurinia says it will now proceed with conducting a randomized, placebo-controlled, double-blind global 52-week trial in approximately 320 patients.
Lupus Nephritis (LN) in an inflammation of the kidney caused by Systemic Lupus Erythematosus (SLE).
Voclosporin is a calcineurin inhibitor (CNI)/immunosuppressant that has a dual mechanism of action. By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses. It is made by a modification of a single amino acid of the cyclosporine molecule which has shown a more predictable pharmacokinetic and pharmacodynamic relationship, an increase in potency, an altered metabolic profile, and potential for flat dosing.
“Selecting a CRO for AURORA is a key milestone for Aurinia following our successful end-of-Phase 2 meeting with the U.S. Food & Drug Administration (FDA) Division of Pulmonary, Allergy and Rheumatology Products,” said Charles Rowland, CEO of the company. He adds that Aurinia is on track to commence the AURORA trial in the second quarter of 2017, with results from this study to be used to support the company’s New Drug Application (NDA) submission to the FDA.
The primary endpoint of the trial, like in its Phase 2b AURA trial is renal response (complete remission), at 24 weeks. In addition to the assessment of renal response, a key marker of clinical benefit in this population is the duration of proteinuria improvement. Secondary endpoints will include the duration of renal response at 52 weeks (48 weeks in AURA), an efficacy measure which delineates durability of renal response (remission), an important parameter in evaluating long-term outcomes for the treatment of LN.