Aurinia Pharmaceuticals Inc. (AUPH) Chief Operating Officer Michael Martin said the company is continuing negotiations with the U.S. Food and Drug Administration over the development of a drug to treat Lupus nephritis, an autoimmune disease.
Speaking at the Stifle 2016 Healthcare Conference in New York on November 16, Martin discussed the progress of the biopharmaceutical company’s clinical trial of voclosporin, an immunosuppressant.
Next Phase Starts 2017
“(With the FDA) there is alignment on the pathway forward,” he said, confirming that the next phase of the study will start in the first half of 2017. The company is also seeing an improvement in the rates of achieving remission, Martin said, but added that the FDA has requested they change the nomenclature of their final goal from “complete remission” to “renal response” and extend its blinded test from 24 to 52 weeks in the next phase.
Lupus nephritis is kidney inflammation caused by systemic lupus erythematosus, according to the National Institute Diabetes and Digestive and Kidney Diseases, and its symptoms include high blood pressure and swelling in the legs and feet. It’s often caused by a genetic predisposition and is typically treated with medications that suppress the immune system.
Researchers say that it affects up to 60 percent of people with lupus, or about 200,000 patients in the U.S. If the drug will be approved, Aurinia expects sales from the nation’s market to reach $1 billion. The company is also in talks with regulators in Europe and Japan, where it estimates total sales above $300 million and $80 million respectively.
“Lupus nephritis is a devastating, often overlooked disease that severely impacts a patient’s quality of life and, in the worst cases, can lead to end-stage renal disease or even death,” said Dr. Mary Anne Dooley, of the University of North Carolina Kidney Center, who presented the company’s study findings at the annual meeting of the American College of Rheumatology and Association of Rheumatology Health Professionals in Washington D.C on November 15. ”We have demonstrated that voclosporin successfully achieves not only higher complete remission rates but does so more rapidly in patients with LN.”
Tested in 2,000 Patients
Aurinia’s Voclosporin is an investigational drug that has been tested on over 2,000 patients with different conditions, according to Aurinia’s website. It aims to inhibit a protein that activates the cells that regulate the immune system, which, in the patients affected by Lupus, is said to create antibodies that attack the body’s own tissues and organs.
The company is currently studying the efficacy of voclosporin added to current standard of care of mycophenolate mofetil — which favors renal response — and low doses of steroids, the company said in a press release.
The development of the clinical study is being closely monitored by associations such as the Lupus Foundation of America and Lupus Research Alliance. In August, after the release of the first set of data, the foundation’s President Sandra C. Raymond said that they look forward to “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.”
However, Lupus Research Alliance remain cautious on the benefits of the investigational drug. “The magnitude of benefit is quite striking and unprecedented in lupus nephritis, but the number of deaths is a concern that must be taken seriously,” said Co-Ceo Margaret G. Dowd in a statement. “We are very hopeful that further analysis of the safety data will confirm that voclosporin can provide a safe and effective treatment for this devastating disease.” In August the company announced 13 patients in Asia died during the treatment though attributing the cause to the severe medical condition.
Aurinia is a British Columbia, Canada-based clinical stage biopharmaceutical company and currently has no approved competitors in the field of Lupus nephritis treatment.