A 357-subject Phase 3 clinical trial evaluating Aurinia Pharmaceuticals’ (NASDAQ:AUPH) lead drug voclosporin, combined with mycophenolate and low-dose corticosteroids, in lupus nephritis patients met the primary and key secondary endpoints.
Specifically, 48% of treated participants achieved renal response at week 52 (the primary endpoint) compared to 22.5% for placebo (p<0.001).
Statistically significant results were also observed in the proportion of renal responders at week 24 (32.4% vs. 19.7%), partial responders at weeks 24 and 52 and time to achieve a urinary protein-to-creatinine ratio (UCPR) of 0.5 or less.
No new safety signals were observed.
Additional data will be submitted for presentation at a future medical conference.
The company plans to file a U.S. marketing application in H1 2020 under Fast Track status.
Management will host a conference call tomorrow, December 5, at 8:30 am ET to discuss the results.
Shares, currently halted, will resume trading at 4:35 pm ET.
Update: Shares up 115% after hours.
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