Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) shares saw a handy gain on Thursday morning after the company announced plans for a late-stage trial in the treatment of lupus nephritis. After the company completed its Phase 2 meeting with the U.S. Food & Drug Administration (FDA) Division of Pulmonary, Allergy and Rheumatology Products, Aurinia believes this Phase 3 clinical trial, with a design consistent with the ongoing AURA study, will support a New Drug Application (NDA) submission.
The Phase 3 AURORA trial will be a global 52-week controlled study of roughly 320 patients. Aurinia is finalizing the study protocol and regulatory submissions with trial initiation expected in the second quarter of 2017.
The study population will be comprised of patients with biopsy-proven active LN who will be evaluated on the primary efficacy endpoint of renal response at 24 weeks.
While voclosporin has received fast track designation, the FDA has informed Aurinia that voclosporin is not eligible for breakthrough therapy designation at this time. The company will continue to benefit from its fast track designation which includes more frequent communications with the FDA and potential for priority review and an option to submit a rolling NDA submission, which may further expedite the review process.
Lawrence D. Mandt, Vice President of Quality and Regulatory Affairs at Aurinia, commented:
We have shared a substantial amount of efficacy and safety data with the FDA and are confident in our ability to execute a successful Phase III clinical trial based on their feedback and the information gleaned from the AURA study. We remain committed to addressing the unmet needs of patients living with LN, a devastating disease, and look forward to making this product available to patients as soon as possible.
Excluding Thursday’s move, Aurinia has outperformed the broad markets, with the stock up about 12% year to date.
Shares of Aurinia were trading up 14% at $3.16 early Thursday, before dropping back to $2.88. The consensus analyst price target is $8.90, and a 52-week trading range of $1.42 to $5.69.