Aurinia Pharmaceuticals and Lonza have entered into a long-term manufacturing agreement over the active pharmaceutical ingredient (API) in voclosporin, Aurinia’s investigative drug for diseases that include lupus nephritis (LN). The agreement aims toward providing an eventual commercial supply of voclosporin, and includes its use in an upcoming and possibly pivotal clinical trial in LN patients.
Aurinia is in the process of starting a Phase 3 trial of voclosporin — expected to open in mid-2017 — a move the company hopes will provide enough data to request the treatment’s approval.
“Our partnership with Lonza is the culmination of years of collaboration in which we have optimized the complex manufacturing process for voclosporin,” Charles Rowland, chief executive officer of Aurinia, said in a press release. “As we prepare to advance voclosporin into an LN Phase III program, we are investing in the infrastructure to deliver this important therapy to patients living with this devastating disease.”
Lonza will be responsible for the production of current Good Manufacturing Practice (cGMP)-grade voclosporin to be used in the upcoming clinical program, as well as for future commercialization. Lonza may be exclusively suppling API to Aurinia for up to 20 years.
“We’re looking forward to further developing our partnership with Aurinia to supply this innovative medicine to lupus nephritis patients around the world,” said Gordon Bates, a senior vice president at Lonza. “As Voclosporin requires a complex manufacturing process, our expertise in scaling multi-step synthesis at clinical and commercial scale allows us to support Aurinia to and through Phase III clinical trials.”
Voclosporin is an investigational immunosuppressant with a synergistic and dual mechanism of action that can potentially improve near- and long-term outcomes in lupus patients when added to standard of care. Aurinia recently completed a Phase 2b clinical trial, called AURA-LV (AURA) of voclosporin plus standard care in LN patients, with data showing the drug has a positive therapeutic effect, with significant numbers of treated patients achieving complete or partial remission, compared to placebo, after 24 weeks of treatment.
The planned Phase 3 trial, to be called AURORA, is expected to run for 52 weeks at multiple locations worldwide, and to enroll about 320 lupus nephritis patients.
Aurinia is hoping to soon meet with the U.S. Food and Drug Administration (FDA) to discuss further plans for the drug’s clinical development, and to plan a path for its potential approval as an LN treatment.