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news.Canada-based Aurinia Pharmaceuticals will start an open label, exploratory trial (AURION) to evaluate the short-term predictors of response using voclosporin in combination with mycophenolate mofetil in patients with active lupus nephritis.
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AURION is designed to examine biomarkers of disease activity at eight weeks and their ability to predict response at 24 and 48 weeks.
Patient enrolment in this small pilot trial is expected to be completed by the third quarter of 2015.
According to the company, the study will act in support of its ongoing lupus nephritis clinical program as well as provide the lupus community with a more clear understanding of voclosporin’s time to onset of action and clinical outcomes.
Aurinia Pharmaceuticals chief medical officer and co-author of ALMS Dr Neil Solomons said: "We believe the AURION study has the potential to provide validation for these early biomarkers and provide valuable tools to clinicians who are managing patients with this debilitating disease."
Voclosporin is a calcineurin inhibitor (CNI) with extensive clinical data in more than 2,600 patients in other indications.
The drug is made by a modification of a single amino acid of the cyclosporine molecule resulting in a more predictable pharmacokinetic and pharmacodynamic relationship, an increase in potency versus cyclosporine, an altered metabolic profile and potential for flat dosing.