Aurinia (AUPH) Says Open-Label AURION Data Shows Increased Remission Rates
- AT&T (T) to Acquire Time Warner (TWX) for $107.50/Share
- Rockwell Collins (COL) to Acquire B/E Aerospace (BEAV) for $6.4B
- China Oceanwide to Acquire Genworth Financial (GNW) for $2.7B
- Top 10 News for 10/17 - 10/21: Merger Rumors Abound; CEOs Depart; Tesla Kicks Autopilot Up A Notch
- Wall Street ends little changed; Microsoft hits record
Find out which companies are about to raise their dividend well before the news hits the Street with StreetInsider.com's Dividend Insider Elite. Sign-up for a 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
- Midstates Petroleum (MPO) Completes Ch. 11 Bankruptcy; Will Trade Under 'MPO'
- PayPal says some customers unable to make payments due to cyber attack on Dyn
- Amgen (AMGN) Announces XGEVA vs. Zoledronic Acid Study Met Primary Endpoint; Secondary Endpoints Missed
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!