Aurinia (AUPH) Says Open-Label AURION Data Shows Increased Remission Rates
- Top 10 News for 12/2: Crude Rips on OPEC Cut; Starbucks' Schultz Steps Down; Nonfarm Payrolls Flat in Nov.
- Unemployment Rate Drops to 4.6%
- Bond yields slip on U.S. jobs data, euro steady before Italy vote
- Alibaba (BABA) Founder Jack Ma Discuss Plans to Retire; 'I Don't Want to Die at the Office'
- Starbucks Coffee (SBUX) CEO Howard Schultz to Step Down, Appointed Executive Chairman; Kevin Johnson New CEO
Get access to the best calls on Wall Street with StreetInsider.com's Ratings Insider Elite. Get your Free Trial here.
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX: AUP) (“Aurinia” or the “Company”) a clinical stage biopharmaceutical company focused on the global immunology market, today announced 24-week data in all 10 patients from the AURION study, an open-label exploratory study to assess the short-term predictors of response using voclosporin (23.7mg BID) in combination with mycophenolate mofetil (MMF) and oral corticosteroids in patients with active lupus nephritis (LN). The data are being presented by Robert Huizinga, Vice President of Clinical Affairs at Aurinia at the 10th Annual European Lupus Meeting in Venice, Italy.
The primary objective of the study is to examine biomarkers of disease activity at eight weeks and their ability to predict response at 24 and 48 weeks.
In this study, 70% (7/10) patients achieved complete remission (CR) at 24 weeks as measured by a urinary protein creatinine ratio (UPCR) of ≤ 0.5mg/mg, eGFR within 20% of baseline and concomitant steroid dose of <5mg/day. Of the 10 patients that achieved a reduction of UPCR of ≥ 25% at 8 weeks, 80% were responders (≥ 50% reduction in UPCR over baseline) at 24 weeks and 70% were in CR at 24 weeks. In addition, inflammatory markers such as C3, C4 and anti-dsDNA all continued to normalize to 24 weeks. Voclosporin was well-tolerated with no unexpected safety signals observed.
“The results of AURION provide further proof of concept data to support voclosporin’s use in the treatment of active LN and continue to indicate that 23.7mg BID is the optimal dose to advance into our phase III program,” said Neil Solomons, MD, Chief Medical Officer of Aurinia. “We are encouraged by our ability to quickly predict responses and remission rates in these patients, which can help clinicians optimize patient care and long-term outcomes.”
Details of the results are below:
Attained ≥25%reduction in UPCRat 8 weeks
Attained Partial Remission*at 8 weeks
Attained Partial Remission* at 24 weeks
Attained Complete Remission at 8 weeks
Attained Complete Remission at 24 weeks
|TOTALS:||100% (10/10)||70%(7/10)||80% (8/10)||50% (5/10)||70% (7/10)|
*Retrospectively defined by ≥50% reduction in UPCR
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Skyline Medical (SKLN) Appoints New CEO, Board Member
- Shire's (SHPG) Phase 3 Investigational Study of VONVENDI Meets Primary Endpoint in Controlling Bleeding in Adults with VWD
- Senseonics Holdings (SENS) Enters Expanded Distribution Agreement with Roche (RHHBY)
Create E-mail Alert Related CategoriesCorporate News, FDA, Hot Corp. News, Management Comments, Momentum Movers
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!