Pharma Focus Asia

Everest Medicines Receives Approval for Investigational New Drug Application of Zetomipzomib in China

Monday, December 04, 2023

Everest Medicines (HKEX 1952.HK) has recently obtained approval from the China National Medical Products Administration (NMPA) for its investigational new drug (IND) application concerning zetomipzomib. Zetomipzomib, an innovative immunoproteasome inhibitor designed to address various immune-mediated disorders, particularly lupus nephritis (LN), is set to be evaluated in collaboration with Kezar Life Sciences in the PALIZADE global Phase 2b clinical trial.

Lupus nephritis, a prevalent secondary immune-mediated glomerular disease affecting an estimated 400,000-600,000 individuals in China, has the potential to progress to kidney failure. Rogers Yongqing Luo, the CEO of Everest Medicines, has expressed optimism about the IND acceptance, highlighting its significance for entering clinical studies in China and the company's dedication to renal and autoimmune diseases.

Zetomipzomib, which exhibited positive outcomes in a prior Phase 2 trial with notable overall renal response rates and a favorable safety profile, is poised to undergo further investigation in the PALIZADE trial. This trial will enroll 279 patients globally, assessing two dose levels of zetomipzomib over 52 weeks in conjunction with standard background therapy. The primary efficacy endpoint of the trial is the proportion of patients achieving a complete renal response at Week 37.

KZR-616, zetomipzomib is a selective immunoproteasome inhibitor with broad therapeutic potential for severe, chronic autoimmune diseases. Supported by preclinical and clinical data attesting to its safety and tolerability profile, zetomipzomib stands as a promising candidate for continued development. The PALIZADE trial signifies a significant advancement in Everest's commitment to advancing treatments for autoimmune diseases, establishing its leading position in Asia's therapeutic landscape.



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