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Item 7.01
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Regulation FD Disclosure.
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On December 9, 2021, Aurinia Pharmaceuticals Inc. announced positive topline results from the AURORA 2 continuation study evaluating the long-term safety and tolerability of LUPKYNIS™ (voclosporin) for the treatment of adults with active lupus nephritis (LN), a serious complication in patients with systemic lupus erythematosus (SLE). In combination with background immunosuppressive therapy, LUPKYNIS is the first and only FDA-approved medicine with three years of pivotal trial results, including long-term safety data, within LN.
Highlights of topline results from AURORA 2:
•In the 116 subjects in the voclosporin-treated group who enrolled in AURORA 2, mean estimated glomerular filtration rate (eGFR) was stable over 36 months.
◦Compared to the active control group, the voclosporin-treated group showed an increase from baseline eGFR at the end of the studies of +2.7 mL/min.
•The drug was well tolerated with no unexpected safety signals observed. There were comparable serious adverse events (SAEs) rates in both arms (19% voclosporin vs. 24% control).
•The active control group had a higher percentage of withdrawals compared to the voclosporin-treated group, 15.0% vs. 12.9% respectively.
•There were 4 deaths during AURORA 2 in the active control group, none in the voclosporin-treated group.
•The mean Urine Protein Creatinine Ratio (UPCR) was lower in the voclosporin-treated groups at all time points during the three years.
AURORA 2 Study Design
AURORA 2 (NCT03597464) is a Phase 3 randomized, double-blind, placebo-controlled clinical trial to assess the long-term safety and tolerability of voclosporin, in addition to MMF/steroids. Patients who completed 12 months of treatment in the Phase 3 AURORA 1 study were eligible to enroll in the AURORA 2 continuation study with the same randomized treatment of voclosporin at 23.7 mg twice daily or placebo, in combination with MMF at 1 g twice daily with low-dose oral steroids, for up to an additional 24 months. A total of 216 LN patients out of 357 who were enrolled in the AURORA 1 study continued into AURORA 2, with 116 patients in the voclosporin group and 100 patients in the control group. 90 and 78 patients, respectively, received 36 months of total treatment at the completion of the study. Results from the completed Phase 3 randomized, double-blind, placebo-controlled, multicenter AURORA 1 study (NCT03021499) were recently published in The Lancet.
The information in this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference into any of our filings under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date hereof, regardless of any general incorporation language in such filing. The furnishing of this information hereby shall not be deemed an admission as to the materiality of any such information.
The information contained in Exhibit 99.1 is summary information that is intended to be considered in the context of our Securities and Exchange Commission filings and other public announcements that we may make, by press release or otherwise, from time to time. We undertake no duty or obligation to publicly update or revise such information, except as required by law.