The Chinese National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) has approved Kezar’s application to begin the Phase IIb PALIZADE trial of zetomipzomib for lupus nephritis (LN).
In December 2023, the NMPA accepted an investigational new drug (IND) application for zetomipzomib in China.
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Zetomipzomib is a selective immunoproteasome inhibitor being developed by Everest Medicines and Kezar Life Sciences to treat multiple autoimmune diseases.
Everest Medicines will work with Kezar to enrol trial subjects in China for the PALIZADE trial.
The international, placebo-controlled trial is intended to assess the safety and efficacy of zetomipzomib in individuals with active LN.
It aims to enrol 279 subjects, who will be randomised to receive either 30mg or 60mg of zetomipzomib, or a placebo, once a week for 52 weeks, alongside standard background therapy.
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By GlobalDataThe PALIZADE trial will include a mandatory corticosteroid taper over the first 16 weeks to 5mg a day or less.
Its primary efficacy endpoint will be measured at week 37, focusing on the proportion of subjects who attain a complete renal response (CRR).
The CRR includes a urine protein-to-creatine ratio (UPCR) of 0.5 or less without the need for rescue or prohibited treatments.
In September last year, Everest secured sole rights for the development and marketing of zetomipzomib across Greater China, South Korea and South-East Asia.
Everest Medicines CEO Rogers Yongqing Luo said: “With the approval of the zetomipzomib IND in China, Everest now has three medicines in the renal space either commercialised or in clinical development.
“We are excited about the initiation of this clinical trial with the potential to benefit patients with LN experiencing critical unmet medical needs.
“We intend to leverage our expertise in clinical development, regulatory filings and our newly established commercial infrastructure in China to advance the development of zetomipzomib.”
