Aurinia selects Worldwide Clinical Trials as CRO for phase 3 lupus nephritis study

Charles Rowland, Chief Executive Officer of Aurinia, said: “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. We are thrilled to partner with Worldwide to support the AURORA Phase 3 clinical trial.

“We are rapidly moving forward with our plans to bring this important therapy to market for patients living with this devastating disease, and Worldwide’s deep expertise and capabilities in managing pivotal trials will be a tremendous asset to us. We are on track to commence the AURORA trial in the second quarter of 2017, and we expect the results from this study will support a New Drug Application (NDA) submission to the FDA.”

With support from Worldwide, Aurinia will proceed with conducting a randomized, placebo-controlled, double-blind global 52-week trial in approximately 320 patients.

The primary endpoint as in the 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. Therefore, 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.

Peter Benton, President and Chief Operating Officer at Worldwide Clinical Trials, said: “Our entire Worldwide team is delighted to have been selected as Aurinia’s CRO partner to advance voclosporin, which has the potential to become the first FDA-approved treatment for LN.

“We’re truly honored that an innovator like Aurinia recognizes what Worldwide brings to the table: medical and scientific expertise, proactive insight, dogged determination, rigorous processes and a commitment to getting it right. We’re looking forward to working closely with Aurinia’s clinical development team on this new therapy, which could significantly improve the lives and long-term outcomes of patients suffering from LN.”

Voclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor (“CNI”) with clinical data in over 2,000 patients across indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action that has the potential to improve near- and long-term outcomes in LN when added to standard of care (MMF). 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.

The Company anticipates that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries.