SHANGHAI, China - Everest Medicines and Kezar Life Sciences (NASDAQ:KZR), Inc. have received approval from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) to initiate a Phase 2b clinical trial for zetomipzomib, a treatment for lupus nephritis (LN), in China.
The trial, named PALIZADE, will assess the efficacy and safety of zetomipzomib in patients with this autoimmune kidney disease.
Zetomipzomib is described as a first-in-class selective immunoproteasome inhibitor, which has been shown in preclinical research to reduce inflammation in animal models of autoimmune diseases without causing immunosuppression. Phase 1 and Phase 2 clinical trials have indicated that the drug has a favorable safety and tolerability profile.
The PALIZADE trial is a global, placebo-controlled, randomized, double-blind study, which will enroll 279 patients with active lupus nephritis. Participants will be assigned to receive either 30 mg or 60 mg of zetomipzomib, or a placebo, once weekly for 52 weeks, alongside standard background therapy.
The primary measure of the drug's efficacy will be the proportion of patients who achieve a complete renal response at Week 37.
Everest Medicines, which specializes in pharmaceutical products for Asian markets, acquired the rights to develop and commercialize zetomipzomib in Greater China, South Korea, and Southeast Asia in September 2023.
According to Everest's CEO, Rogers (NYSE:ROG) Yongqing Luo, the company is poised to leverage its expertise to advance the development of zetomipzomib, aiming to address the unmet medical needs of lupus nephritis patients.
Kezar Life Sciences, a clinical-stage biopharmaceutical company, is working in collaboration with Everest to drive enrollment in the PALIZADE trial. Christopher Kirk, Ph.D., CEO of Kezar, expressed confidence in Everest as a regional partner for the development of the drug.
Lupus nephritis is a severe condition that can lead to kidney failure, affecting an estimated 400,000-600,000 patients in China. The approval of the IND for zetomipzomib represents a significant step forward in the potential treatment of this disease.
This news is based on a press release statement and reflects the current status of the clinical development of zetomipzomib. It is important to note that forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors that could affect the actual results.
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