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Voclosporin Meets Primary Endpoint in Lupus Nephritis Trial
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Aurinia Pharmaceuticals Inc. announced voclosporin met its primary endpoint in a phase 2B trial of patients with lupus nephritis enrolled in the AURA-LV trial, according to a company press release.
The results of the trial showed both 23.7 mg and 35.9 mg twice daily doses in addition to standard of care with mycophenolate mofetil resulted in statistically significant remission rates.
“We are pleased by these encouraging results and are grateful to those that participated in our clinical trials,” Neil Solomons, MD, Aurinia’s chief medical officer, said in the release. “The AURA study was conducted under rigorous and stringent criteria, enhancing our confidence in voclosporin’s potential ability to provide a substantial improvement over the currently accepted standard of care, especially given that study participants had such active disease and were exposed to such a low corticosteroid load.”
Following the 24-week analysis, Aurinia plans to meet with the FDA later in the year to develop a plan to authorize the drug for treatment of lupus nephritis and to submit 48-week data in 2017.
“The results of this trial are welcomed and exciting news for people with lupus and their doctors who are eager to have more tolerable and effective treatments options,” Sandra C. Raymond, president and chief executive officer of the Lupus Foundation of America, said. She added, “We look forward to the timely commencement of a phase 3 trial; and, should the findings confirm this study, the addition of this regimen to the arsenal of treatments available to people who have waited far too long for medicines that improve the quality of their lives.”
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