January 10, 2017
By Renee Morad, BioSpace.com Breaking News Staff
SAN FRANCISCO –Patients diagnosed with lupus nephritis (LN), an often overlooked but serious condition, suffer from inflammation of the kidney that is caused by lupus erythematosus (SLE), also known as lupus for short. The overwhelming majority of patients are women—and many are of childbearing age, which makes high-steroid treatment options counterintuitive for those hoping to have children in the future. Left uncontrolled, the condition can lead to irreversible kidney damage, resulting in end-stage renal disease (ESRD).
Aurinia Pharmaceuticals is on a mission to change the standard of care for this disease. With CEO Charlie Rowland at the helm, the company is working to bring voclosporin, its immunosuppressant drug candidate, to market. Voclosporin’s synergistic and dual mechanism of action has the potential to improve near- and long-term outcomes of LN patients when added to the standard of care, mycophenolate mofetil (MMF).
Recent clinical data suggests that adding voclosporin to the standard of care can be successful in getting patients into partial or complete remission faster. The AURA study is the first global LN study to meet both its primary and all secondary endpoints, demonstrating a rapid response rate in LN patients with complete remission in the sixth week while maintaining normal, stable renal function. Some 33 percent of patients in the voclosporin 23.7mg BID arm achieved complete remission at 24 weeks.
“It’s important to get patients into remission faster, because it stops damage to the kidneys,” Rowland says. “There are also two big things we’re really excited about: If in complete remission, 90 percent of patients will have a pretty good outcome 10 years out, and if in partial remission, 40 percent will have a pretty good outcome 10 years out.”
Voclosporin, which was recently granted “fast track status” by the FDA, is desired over high-steroid treatments, especially among female patients, which represents 85 percent of the LN patient population.
When Rowland stepped in as CEO last April, after sitting on the board, he took steps to change the strategic direction of the company. For instance, he brought in Brad Dickerson, formerly senior director of brand support for RX Crossroads Specialty Solutions. Dickerson has a proven track record of bringing drugs to market. At Aurinia, he is working to best position the drug for success, which includes making determinations about drug pricing and establishing treatment guidelines.
Rowland also has an eye on expansion and has implemented a road map with triggers for when the company will broaden its reach. For example, the map details milestones for the future and precisely when more clinical, patient services and medical science liaison professionals will be called on.
In the near-term, Rowland says the company plans to hire several people to fill clinical and medical science liaison positions, which will be critical as Aurinia gears up for a Phase III clinical trial of voclosporin beginning in the second quarter of 2017.
“The clinical community has shown a lot of enthusiasm about our work,” Rowland says. “We’ve received a lot of inbound calls from clinicians and patients who want to be a part of our Phase III study.”
See Finding a Complementary Secondary Endpoint in Lupus Clinical Trials
