Aurinia Pharmaceuticals Inc. (AUPH) concluded meetings with both the European Medicines Agency (EMA) and the Japanese agency Pharmaceutical and Medical Devices Agency (PMDA) related to its lupus drug voclosporin.

Based on the discussions, the Canada-based biopharmaceutical company said it's confident that results expected from a single Phase 3 clinical trial (called AURORA), and those from the recently-completed AURA-LV (AURA) Phase 2b trial, should be sufficient to support regulatory submissions in the US, Europe and Japan for voclosporin. (See also, Aurinia's Voclosporin Reports Positive Results.)

Plans 320-Patient Trial

The planned late-stage trial is expected to enroll 320 patients to assess the drug’s effectiveness in achieving renal response in patients with lupus nephritis (LN). Patients will be randomized in two separate arms, with each arm given either a combination of 23.7mg voclosporin and mycophenolate mofetil (MMF) or MMF and placebo, along with other necessary constituents. MMF (CellCept) is the current standard of care for the disorder, while placebo is a substance that has no therapeutic effect, and is used as a control in testing new drugs.

“Our interactions with regulators in all three jurisdictions have given us a clear pathway for Phase III, and we are confident in our ability to execute AURORA successfully based on their feedback and the information gleaned from the AURA study,” said Lawrence D. Mandt, Vice President of Quality and Regulatory Affairs at Aurinia.

Lupus is an inflammatory disorder which is caused when the immune system mistakenly attacks its own tissues. The disease can affect a number of body parts, including the joints, skin, kidneys, blood cells, brain, heart and lungs. Lupus nephritis is a severe disorder leading to inflammation of the kidney, and affects around 60% of the lupus patients. It is most commonly a result of genetic predisposition, and treatments include effective medications that work by suppressing the immune system.

Following the update, Aurinia's stock price spiked 11% during pre-market hours. (See also, Aurinia Offers Promising 2017 Forecast.)

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