Yesterday afternoon, Victoria, B.C.-based late-stage clinical biopharmaceutical company Aurinia Pharmaceuticals Inc. (AUPH:NASDAQ; AUP:TSX), which is focused on advancing voclosporin across multiple inflammatory and autoimmune conditions, announced "positive efficacy and safety results from its pivotal AURORA Phase 3 trial of voclosporin, in combination with mycophenolate mofetil (MMF) and low-dose corticosteroids, in the treatment of lupus nephritis (LN)."
The firm indicated that the Phase 3 AURORA clinical trial is a global, randomized, double-blind study of 357 LN patients in 27 countries to evaluate whether voclosporin when added to background therapy of MMF/CellCept can increase the speed and overall renal response rates in the presence of low dose steroids. Aurinia stated that in the trial, it succeeded in reaching its primary endpoint of renal response rates for voclosporin compared to the control group. The company further advised that voclosporin was well tolerated with no unexpected safety signals and that all pre-specified secondary endpoints achieved statistical significance in favor of voclosporin.
Aurinia claims that voclosporin is an investigational immunosuppressant drug, and is a novel and potentially best-in-class calcineurin inhibitor with clinical data in over 2,600 patients across indications. The company noted that voclosporin was granted Fast Track designation by the FDA in 2016 and that the company plans to submit an NDA to the FDA in H2/20.
The company's Chief Medical Officer Neil Solomons, M.D., commented, "This extraordinary pivotal data confirms voclosporin's ability to achieve statistically significant improvements in clinically meaningful endpoints for this complex disease, with a comparable safety profile to the current standard of care...This data represents a significant advance for people living with LN, which can lead to irreversible kidney damage, eventual kidney failure and death."
Brad Rovin, MD, FASN, chief of the Division of Nephrology and medical director of the Clinical Trials Management Organization at The Ohio State University Wexner Medical Center, added, "These data represent a potential game changer for patients suffering from this debilitating disease...This confirmatory Phase 3 result represents a clinically meaningful leap forward in the treatment of lupus nephritis. Importantly, the data indicate no excess of adverse events in the voclosporin group compared to patients managed with standard of care alone."
Aurinia's President and CEO Peter Greenleaf remarked, "We are thrilled with the outcomes reported today from the AURORA trial, which unequivocally demonstrate the tremendous potential for voclosporin to play an important role in the treatment of the approximately one million people worldwide living with LN...We are aware of the intense need for a clinically impactful therapy for this serious disease and are working with urgency to complete regulatory filings in the U.S. and worldwide. If approved, we look forward to potentially making voclosporin available to patients beginning in 2021."
Stevan W. Gibson, president and CEO of the Lupus Foundation of America added, "The treatment of lupus nephritis has been extremely challenging to date, and people with lupus are in need of innovative treatments for this serious disease...Voclosporin is the first novel treatment that has demonstrated therapeutic efficacy for people living with lupus nephritis and today marks an important advance in the treatment of this potentially life-threatening disease."
The company explains in the report that "LN is an inflammation of the kidney caused by Systemic Lupus Erythematosus...In patients with LN, renal damage results in proteinuria and/or hematuria and a decrease in renal function." LN can lead to permanent and irreversible tissue damage within the kidney, resulting in end-stage renal disease.
Aurinia Pharmaceuticals, headquartered in Victoria, British Columbia, is a late clinical-stage biopharmaceutical company focused on developing and commercializing therapies to treat patients in the fields of nephrology and autoimmunity. The company is currently developing voclosporin, an investigational drug, for the treatment of lupus nephritis, focal segmental glomerulosclerosis and dry eye syndrome.
Aurinia Pharmaceuticals started off the day with a market capitalization of approximately $791.1 million with about 94.28 million shares outstanding and around a 10.1% short interest. AUPH shares opened nearly 100% higher today at US$16.70 (+$8.31, +99.05%) over yesterday's $8.39 closing price. The stock established a new 52-week high price of US$17.48 this morning. The firm's shares have traded today on higher than average volume between US$14.75 and US$17.48 per share and are currently trading at US$16.04 (+$7.61, +90.95%).[NLINSERT]
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