British Columbia-based Aurinia Pharmaceuticals has announced positive results from the fourth and final safety review of the company’s Phase 2b AURA LV clinical trial, which is evaluating the efficacy of its lead drug voclosporin as a treatment for active lupus nephritis. The review was conducted by the Data and Safety Monitoring Board, which recommended the study continues as planned without any modifications.
Voclosporin, a novel calcineurin inhibitor (CNI), is made by the modification of a single amino-acid of the cyclosporine molecule, which has been CNI-approved for use in transplant patients since 1983. The modification results in an increased therapeutic potency, potential for flat dosing, and more reliable pharmacokinetic and pharmacodynamics features.
The AURA-LV study is a Phase 2b randomized, controlled, double-blind clinical trial (NCT02141672) that was designed to compare the efficacy of the drug at a high (39.5 mg) and low (23.7 mg) dose, against a placebo, to induce remission in patients with lupus nephritis (LN). The primary outcome is set at the number of patients achieving complete remission at 24 weeks, while secondary outcomes will assess the same measure at 48 weeks. The study, currently ongoing in more than 20 countries around the world, had completed enrollment earlier this year, reaching a total of 265 patients. Release of the primary endpoint data is expected in the third quarter of this year.
The committee evaluated the available safety data, according to the FDA Guidance for Clinical Trial Sponsors, on patients who were treated for at least one month.
“We are encouraged by the consistent recommendations of the DSMB,” Neil Solomons, M.D., chief medical officer of Aurinia, said in a news release. “We look forward to assessing the risk-benefit of multi-target therapy utilizing voclosporin when reviewing the primary endpoint and key 24 week efficacy and safety data in the third quarter of this year.”
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