Blog Coverage Aurinia Chooses Worldwide Clinical Trials as CRO for AURORA Phase-3 Study of Voclosporin
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LONDON, UK / ACCESSWIRE / January 30, 2017 / Active Wall St. blog coverage looks at the headline from Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) as the Company announced on January 27, 2017, that it had chosen Worldwide Clinical Trials as its CRO (Clinical Research Organization) for the AURORA Phase-3 Study of Voclosporin for the Treatment of Active Lupus Nephritis. Register with us now for your free membership and blog access at:
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Victoria, British Columbia based Aurinia is a clinical biopharmaceutical company that works to develop and commercialize therapies to treat serious diseases with high unmet medical need. Aurinia is developing an investigational drug for the treatment of Lupus Nephritis (LN).
Worldwide Clinical Trials is a full-service contract research organization (CRO) that partners with pharmaceutical and biotechnology companies and assists them across the various stages of drug development from discovery to clinical development and commercialization. They are equipped to cover a range of therapeutic areas, including neuroscience, cardiovascular diseases, immune-mediated inflammatory disorders (IMID) and rare diseases.
Commenting on the partnership, Charles Rowland, CEO of Aurinia said:
"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."
Peter Benton, President and CEO of Worldwide Clinical Trials, added:
"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."
About the disease - Lupus Nephritis
Lupus also known as System Lupus Erythematosus (SLE) is a chronic, complex and often disabling disorder that affects more than 500,000 people in the US, mostly women. SLE is an extremely heterogeneous disease which can affect the heart, lungs, skin, joints, vascular system, and kidneys.
Lupus Nephritis (LN) in an inflammation of the kidney that represents a serious progression of SLE. It is estimated that as many as 60% of all SLE patients have clinical LN requiring treatment. LN can lead to permanent and irreversible tissue damage within the kidney, resulting in end-stage renal disease, which makes it a serious and potentially life-threatening condition. Currently, there is no FDA approved therapy for treatment for LN.
About the drug Voclosporin
Voclosporin is an investigational drug and a novel and potentially best-in-class calcineurin inhibitor (CNI). Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action that has the potential to improve near- and long-term outcomes in lupus nephritis (LN) when added to standard of care mycophenolate mofetil (MMF). It has been granted "fast track status" by the US Food & Drug Administration (FDA). It has the potential to become the first approved treatment for LN in the US and Europe. The Company expects that once the drug gets FDA approval it would enjoy patent protection in US and other markets including Europe and Japan till October 2027.
The AURORA Study
The AURORA is a 52-week global double-blind Phase-3 study. The aim of the study is to investigate whether Voclosporin, added to the standard of care treatment in active lupus nephritis (LN), is able to reduce disease activity over a treatment period of 24 weeks. The trial is being conducted on approximately 320 patients. The primary aim of the trial is that by the end of week 24, participants in the trial should achieve renal response.
Brief Background and Way Forward
In November 2016, Aurinia had announced that it planned to initiate a single, Phase-3 clinical trial (AURORA) which is designed similarly to that of their ongoing AURA clinical trial. The single Phase-3 clinical trial is for use of Voclosporin in the treatment of lupus nephritis (LN). The announcement was made following Aurinia's successful End of Phase-2 meeting with the US FDA Division of Pulmonary, Allergy and Rheumatology Products. On completing the Phase-3 trials, Aurinia plans to use data from both the AURA and AURORA trials for the applying for a New Drug Application (NDA). Since that time, Aurinia is on a tight schedule to ensure that its team is ready to execute a successful clinical trial. It focused on finalizing the study protocol and regulatory submissions along with site selection and necessary investments so that it can reach its goal. Aurinia has plans to start the Phase-3 AURORA trials in Q2 2017.
The selection of Worldwide as its CRO is the first step in this direction. With the partnership with Worldwide Aurinia will be able to move forward on the 52-week Phase-3 AURORA trials on approximately 320 patients. The experts at Worldwide will work closely with Aurinia's Robert Huizinga, VP of Clinical Development and Rashieda Gluck, VP of Clinical Operations, for completing the AURORA study successfully.
The estimated date of completion of the final data collection of the study to measure the primary outcome is December 2019. The study is expected to be completed by March 2020.
Stock Performance
Aurinia Pharma's share price finished last Friday's trading session at $3.22, jumping 5.57%. A total volume of 7.00 million shares exchanged hands, which was higher than the 3 months average volume of 1.57 million shares. The stock has surged 50.47% and 54.07% in the last month and past twelve months, respectively. Furthermore, since the start of the year, shares of the Company have soared 53.33%. The stock currently has a market cap of $124.92 million.
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