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Aurinia Pharmaceuticals Inc. , a clinical stage biopharmaceutical company focused on the global immunology market, announced that it has received the final End of Phase II (EOP2) meeting minutes from the U.S. Food & Drug Administration Division of Pulmonary, Allergy and Rheumatology Products. The minutes are consistent with the preliminary responses that were issued to the Company prior to the meeting which took place on October 25, 2016.
As previously communicated, Aurinia will be conducting a single, Phase 3 clinical trial assessing 23.7mg BID for the treatment of active lupus nephritis (LN). The trial, which will be known as AURORA, will be a 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. Aurinia believes this Phase 3 clinical trial will support a New Drug Application (NDA) submission.
“We have thoroughly reviewed the final EOP2 meeting minutes provided to us by FDA, which are consistent with our previous assessment and are moving as quickly as we can to initiate the AURORA trial,” commented Lawrence D. Mandt, Vice President of Quality and Regulatory Affairs at Aurinia.”
“We are pleased to be working closely with FDA to bring this treatment to market and helping as many people as possible suffering from this debilitating disease,” added Charles Rowland, Aurinia’s Chief Executive Officer. “Our clinical team has been working on preparations for this important trial to meet our goal of enrolling the first patient in Q2 2017. In the meantime, we expect the AURA 48-week secondary endpoint durability of renal response data in Q1 next year.”
