Everest Medicines and Kezar Life Sciences Receive IND Approval from China NMPA for PALIZADE Trial in Lupus Nephritis

發(fā)布時(shí)間： 2024-02-29 閱讀：472次

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February 27, 2024-Everest Medicines announced today that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) approved Kezar’s investigational new drug (IND) application for initiation of the Phase 2b PALIZADE trial in China of zetomipzomib in patients with lupus nephritis (LN).  Zetomipzomib is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases.

Zetomipzomib (KZR-616) is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases. Preclinical research demonstrates that selective immunoproteasome inhibition results in a broad anti-inflammatory response in animal models of several autoimmune diseases, while avoiding immunosuppression.

Everest will join Kezar and enroll patients in China as part of the ongoing PALIZADE trial, a global, placebo-controlled Phase 2b clinical trial evaluating the efficacy and safety of two dose levels of zetomipzomib or placebo in patients with active LN. Data generated from Phase 1 and Phase 2 clinical trials provide evidence that zetomipzomib exhibits a favorable safety and tolerability profile for development in severe, chronic autoimmune diseases.