Aurinia Pharmaceuticals Inc (NASDAQ:AUPH) announced the outcome of discussions with both the European Medicines Agency (EMA) and the Pharmaceutical and Medical Devices Agency (PMDA) in Japan regarding the development of voclosporin for the treatment of active lupus nephritis (LN). Pursuant to these discussions, the Company believes that the confirmatory data that can be generated from the single Phase III clinical trial (AURORA) and the recently completed AURA-LV (AURA) Phase IIb study should support regulatory submissions in the US, Europe and Japan.
“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. “The productive conclusion of these regulatory interactions marks a milestone in our development program and brings this exciting new therapeutic option one step closer to those patients suffering from LN.”
The Phase III AURORA trial will be a global 52-week double-blind, placebo controlled study of approximately 320 patients. Patients will be randomized 1:1: to either of 23.7mg voclosporin BID and mycophenolate mofetil (MMF) or MMF and placebo, with both arms receiving a stringent oral corticosteroid taper. As in AURA, the study population will be comprised of patients with biopsy-proven active LN who will be evaluated on the primary efficacy endpoint of complete remission, or renal response, at 52 weeks, a composite which includes:
- Urinary/protein creatinine ratio (UPCR) of ≤0.5mg/mg
- Normal, stable renal function (≥60 mL/min/1.73m2 or no confirmed decrease from baseline in eGFR of >20%)
- Presence of sustained, low dose steroids (≤10mg prednisone from week 16-24)
- No administration of rescue medications
“Based on the recent learnings from the positive AURA study at 48 weeks, we intend to use a UPCR of ≤0.5mg/mg and evaluate the primary endpoint at 52 weeks in AURORA,” added Richard M. Glickman, Aurinia’s Chief Executive Officer. “We are on track to initiating the global AURORA study this quarter and fulfilling our goal of improving the long-term outcomes for patients with this disease.”
Shares of Aurinia are up nearly 10% to $7.10 in after-hours trading. AUPH has a 1-year high of $10.54 and a 1-year low of $1.74. The stock’s 50-day moving average is $6.35 and its 200-day moving average is $3.87.
On the ratings front, AUPH has been the subject of a number of recent research reports. In a report issued on March 22, FBR analyst Vernon Bernardino reiterated a Buy rating on AUPH, with a price target of $11, which implies an upside of 67% from current levels. Separately, on March 10, Canaccord’s John Newman reiterated a Buy rating on the stock and has a price target of $10.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Vernon Bernardino and John Newman have a yearly average loss of 7.7% and 7.8% respectively. Bernardino has a success rate of 28% and is ranked #4445 out of 4553 analysts, while Newman has a success rate of 36% and is ranked #4461.
Aurinia Pharmaceuticals, Inc. operates as a biopharmaceutical company. It focuses on discovery and development of immunomodulating therapeutics. Its products include voclosporin and non-immunosuppressive cyclosporine analogue molecules for the treatment of lupus nephritis.