Aurinia Pharmaceuticals will host a lupus nephritis expert breakfast on Thursday, Aug. 4, from 8:00 a.m. to 9:30 a.m. in New York City, to discuss the results of its latest clinical trial in treating lupus nephritis. Other topics at the breakfast, intended for investors, sales analysts, and business development professionals, include current lupus treatments, disease burden, and pharmacoeconomic and pricing dynamics for new products for less common diseases in the U.S. market.
Aurinia is conducting the fully enrolled Phase 2b AURA-LV clinical trial to evaluate the efficacy of voclosporin, its lead drug candidate, as a treatment for active lupus nephritis. Voclosporin is an investigational calcineurin inhibitor (CNI) developed through the modification of a single amino acid of the cyclosporine molecule, a CNI that was approved in 1983 for transplant patients.
The AURA-LV study (NCT02141672) is evaluating if voclosporin can induce an effective and sustained reduction of proteinuria in the presence of extremely low steroid exposure. The clinical trial has enrolled 265 patients in over 20 countries, and will compare the efficacy of two different doses of voclosporin (23.7 mg and 39.5 mg) against placebo in achieving disease remission. All patients will receive mycophenolate mofetil (MMF) and oral corticosteroids as background therapy. A primary analysis to determine complete remission will be done at 24 weeks, and confirmed at week 26. Secondary analyses will assess biomarkers and markers of non-renal lupus at week 48.
The breakfast will also include a review of the most recent proof of concept AURION clinical trial, an open-label exploratory study taking place in Malaysia to evaluate the short-term predictors of response using voclosporin (23.7 mg) in combination with mycophenolate mofetil and oral corticosteroids. The study will examine biomarkers of active lupus nephritis at eight weeks, and their ability to predict response at 24 and 48 weeks.
Event guests include Dr. Amit Saxena, an assistant professor at NYU Langone Medical Center; Dr. Doug Paul, Pharm D, PhD, an assistant professor at the University of Mississippi School of Pharmacy; Robert Huizinga, vice president of Clinical Affairs at Aurinia Pharmaceuticals; and Charles Rowland, chief executive officer at Aurinia Pharmaceuticals.