Aurinia (AUPH) Says Open-Label AURION Data Shows Increased Remission Rates

October 6, 2016 8:09 AM EDT
Get Alerts AUPH Hot Sheet
Trade AUPH Now!
Join SI Premium – FREE

Get the Pulse of the Market with's Pulse Picks. 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:

Patient #

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

1 Y Y Y Y Y
2 Y Y Y Y Y
3 Y Y Y N N
4 Y N N N N
5 Y Y Y Y Y
6 Y Y Y Y Y
7 Y N N N N
8 Y Y Y Y Y
9 Y N Y N Y
10 Y Y Y N Y
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 Premium Free!

You May Also Be Interested In

Related Categories

Corporate News, FDA, Hot Corp. News, Management Comments, Momentum Movers

Add Your Comment