Voclosporin, a drug being developed to treat lupus nephritis (LN), appears to be safe for patients regardless of ethnicity, according to a Phase 1 clinical trial conducted in healthy Japanese, Aurinia Pharmaceuticals reports.
The treatment also has a good pharmacokinetic (PK) and pharmacodynamic (PD) profile. PK refers to the body’s reaction to a drug agent, whereas PD is drug’s effect on the body. The study, which compared Japanese results from ethnic sensitivity studies and previous PK and PD analysis in non-Japanese patients, supports further development of voclosporin among these patients.
In the analysis, voclosporin (23.7 mg) showed no statistically significant differences in drug exposure between Japanese and non-Japanese patients.
Aurinia also said PK parameters in Japanese patients were largely consistent with those previously reported in non-Japanese volunteers, with no safety issues observed.
“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,” Lawrence Mandt, Aurinia’s vice-president for quality and regulatory affairs, said in a press release. “Additionally, the data support the use of the 23.7 mg BID [twice a day] 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 in Q2 and confirming our path forward for regulatory submission in Japan.”
Added Aurinia CEO Richard Glickman: “Japan represents an important market opportunity for voclosporin to treat patients with active lupus nephritis. The results of this study will support our upcoming discussions with Japanese regulatory authorities and potential partners as we continue our efforts to bring this important therapy to patients around the globe.”
In January, Aurinia announced it will evaluate voclosporin in a randomized, placebo-controlled, double-blind, 52-week, Phase 3 clinical trial (AURORA, NCT03021499) as a potential treatment for active LN. The study is expected to open in the spring.
Researchers will assess voclosporin’s efficacy, compared to placebo, in achieving renal response (complete remission) in patients with active LN, when added to standard-of-care mycophenolate mofetil (CellCept). Aurinia will use the study’s results to support a New Drug Application to the U.S. Food and Drug Administration.
The efficacy of two doses of voclosporin, compared to placebo, in achieving complete remission after 24 weeks of therapy in patients with active LN is also being evaluated in the ongoing Phase 2b AURA trial (NCT02141672).
Voclosporin is an immunosuppressant with a synergistic dual mechanism of action. It is a calcineurin inhibitor (CNI) that blocks IL-2 expression and T-cell mediated immune responses.