VICTORIA, BC–Aurinia Pharmaceuticals Inc. has released new results from its supportive Phase 1 safety, pharmacokinetic (PK) and pharmacodynamic (PD) voclosporin study in healthy Japanese patients.The company is developing voclosporin as a treatment for patients with active lupus nephritis. Based on evaluations comparing the Japanese ethno-bridging data vs. previous PK and PD studies in non-Japanese patients, the company says voclosporin demonstrated no statistically significant differences in exposure with respect to Area Under the Curve (AUC) measurements. Furthermore, the PK parameters in Japanese patients were generally consistent with previously evaluated PK parameters in non-Japanese volunteers. There were no unusual or unexpected safety signals in the study.
“We are encouraged by these results as they appear to support our hypothesis that the PK and PD of voclosporin is similar among ethnic groups,” said Lawrence Mandt, VP of Regulatory and Quality of Aurinia. “Additionally, the data support the use of the 23.7mg BID voclosporin dose in our global Phase 3 study in both Japanese and non-Japanese patients. We look forward to sharing our findings with the Japanese Pharmaceuticals and Medical Devices Agency (“PMDA”) in Q2 and confirming our path forward for regulatory submission in Japan.”