Canadian company Aurinia Pharmaceuticals is set to commence clinical trials next year for treatment of renal disorders and keratoconjunctivitis sicca or dry eye syndrome (DES) with its drug candidate, voclosoprin.
Voclosporin is an investigational immunosuppressant being developed to inhibit calcineurin, blocking IL-2 expression and T-cell mediated immune responses, as well as stabilising kidney’s podocyte.
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In the first half of next year, the firm will start a Phase II trial for focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD).
The firm is planning for a Phase IIa trial of voclosporin ophthalmic solution (VOS) in the second quarter to treat DES.
Interim data from Phase II and results from the Phase IIa trial are scheduled to be available in the second half.
Furthermore, Aurinia anticipates that the ongoing Phase III clinical trial (AURORA), which has 113 active trial sites for the treatment of lupus nephritis (LN), will complete enrolment in the second half.
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By GlobalDataAurinia Pharmaceuticals chairman and CEO Richard Glickman said: “With the AURORA trial in LN now well underway, we’re poised to enter the next phase of development for Aurinia.
“By leveraging our expertise and the unique profile of voclosporin to pursue these novel indications, we hope to bring new treatment options to patients where significant unmet medical need remains.”
Under the fast drug designation of voclosporin, the firm intends to use a rolling new drug application (NDA) process and is planning for the submission of first module in the second half of next year.
