Canadian-based biopharmaceutical firm Aurinia Pharmaceuticals has begun dosing patients in the Phase III AURORA clinical trial of voclosporin to treat lupus nephritis (LN).
Voclosporin is an investigational immunosuppressant and calcineurin inhibitor with a synergistic and dual mechanism of action.
The drug is formulated by altering a single amino acid of the cyclosporine molecule.
The double-blind, placebo-controlled Phase III trial is designed to enrol approximately 320 patients.
The trial will demonstrate the effect of voclosporin when used in conjunction with the existing standard-of-care of mycophenolate mofetil (MMF) over a period of 52 weeks.
It aims to establish that the addition will enhance the overall renal response rates in the presence of low doses of corticosteroids.
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Aurinia Pharmaceuticals chief medical officer Neil Solomons said: “Dosing our first patient today is an important milestone for the company.
“Our Phase III trial design is nearly identical to that of our successful Phase II AURA trial, which demonstrated the potential of voclosporin to increase both speed and rates of remission in patients with active LN.
“We remain dedicated to advancing this treatment and making a meaningful impact in the lives of patients suffering from LN and those around them.”
The trial will evaluate the efficacy of one dose of 23.7mg voclosporin twice-daily compared to placebo and will measure the complete renal response at 52 weeks as the primary endpoint.