Aurinia Pharma (AUPH) Announces Acceptance of Late-Breaking Voclosporin Abstracts for Two Upcoming Medical Meetings
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Aurinia Pharmaceuticals Inc. (Nasdaq: AUPH announced that two late-breaking abstracts for voclosporin were accepted for oral presentations at the ACR/ARHP Annual Meeting taking place in Washington, D.C. November 11-16, 2016, and ASN Kidney Week taking place in Chicago November 15-20, 2016.
“The selection of voclosporin data for two late-breaking oral presentations at key medical meetings underscores the importance of providing the medical community with new information about therapy advancements in the treatment of lupus nephritis,” said Neil Solomons, M.D., Aurinia’s Chief Medical Officer. “Data presented highlights Aurinia’s commitment to providing lupus nephritis patients with a tolerable and effective treatment option, improving long-term patient outcomes and quality of life.”
The schedule for the oral presentations is as follows:
Session: Late-Breaking Oral AbstractsSpeed of Remission with the Use of Voclosporin, MMF & Low Dose Steroids: Results of a Global Lupus Nephritis Study
Conference: 2016 ACR/ARHP Annual MeetingDate/Time: November 15, 2016, 4:30-6:00 p.m.Presented by: Mary Anne Dooley, M.D., M.P.H., Adjunct Professor of Medicine, University of North Carolina Kidney CenterPresentation Number: 5L
Session: High Impact Clinical TrialsAURA-LV: Successful Treatment of Active Lupus Nephritis with Voclosporin
Conference: ASN Kidney Week 2016 Annual MeetingDate/Time: November 19, 11:50 a.m.Presented by: William Pendergraft, M.D., Ph.D., Assistant Professor of Medicine in the Division of Nephrology & Hypertension at the University of North CarolinaAbstract Number: 6480
The AURA–LV study (Aurinia Urine protein Reduction in Active Lupus with Voclosporin) compared the efficacy of two doses of voclosporin added to current standard of care of mycophenolate mofetil (MMF, also known as CellCept®) against standard of care with placebo in achieving complete remission (CR) in patients with active LN. All arms also received low doses of corticosteroids as background therapy. 265 patients were enrolled at centers in over 20 countries worldwide. On entry to the study, patients were required to have a diagnosis of LN according to established diagnostic criteria (American College of Rheumatology) and clinical and biopsy features indicative of highly active nephritis.
Voclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor (“CNI”) with clinical data in over 2,000 patients in other indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action that has the potential to improve near- and long-term outcomes in LN when added to standard of care (MMF). By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses. It is made by a modification of a single amino acid of the cyclosporine molecule which has shown a more predictable pharmacokinetic and pharmacodynamic relationship, an increase in potency, an altered metabolic profile, and potential for flat dosing. The Company anticipates that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries.
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