After posting positive phase 2 and phase 2b data on its lupus nephritis med voclosporin, Aurinia is eager to move the candidate into phase 3, and now, it has selected Worldwide Clinical Trials as the CRO to conduct the last round of trials before a new drug application.
As a CRO with clinical operations and scientific personnel in more than 60 countries, Worldwide will be responsible for recruiting about 320 patients globally into the 52-week trial assessing the drug at 23.7 mg twice daily, the lower dose in previous trials.
Lupus nephritis, caused by systemic lupus erythematosus, is a potentially life-threatening inflammation of the kidney, and the trial’s primary endpoint—as also in the phase 2b trial—is renal response, or complete remission, at 24 weeks. The trial will also assess the treatment’s long-term result through renal response at 52 weeks as secondary endpoint.
The drug reached its phase 2b primary endpoint by demonstrating a complete response at 24 weeks in 32.6% of patients receiving the lower dose, compared to 27.3% in the higher-dose group and 19.3% in the control arm.
Although all together 12 patients treated with different doses of voclosporin died in phase 2, the company rebutted the notion that the deaths were caused by the drug but by the malignancy of the disease itself, saying in a press release that the adverse events were “consistent with those observed in patients with highly active LN and increased immunomodulation.”
The SLE field didn’t have much to celebrate in recent years. In 2011, GlaxoSmithKline’s Benlysta became the first new lupus treatment approved by the FDA in over 50 years.
Besides Aurinia’s candidate, AstraZeneca is collaborating with PRA Health Sciences in a phase 3 trial that tests the long-term safety of its candidate anifrolumab in patients with active systemic lupus erythematosus. Biogen’s BIIB059 and BIIB068, UCB’s dapirolizumab pegol and Anthera’s subcutaneous blisibimod are all currently in different phases of clinical trials. Both UCB’s epratuzumab and Eli Lilly’s tabalumab didn’t make it through clinical.
Voclosporin is currently under FDA “fast track,” and with 48-week secondary endpoint durability data—the final piece of the phase 2 trial—expected in the first quarter, Aurinia and Worldwide are expecting to enroll the first phase 3 patient in the second quarter of this year.
Last December, Aurinia reached a long-term agreement with Lonza for the manufacture of voclosporin API to support the drug’s clinical programs and for future commercial use. After that, it closed a round of financing worth $28.75 million with H.C. Wainwright as sole bookrunning manager and Cormark Securities as co-manager.