Everest Medicines and Kezar Life Sciences Gets CDE Approval

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

Everest Medicines and Kezar Life Sciences Inc 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.

Partners for Trial

• 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.  
• In September 2023, Everest obtained exclusive rights to develop and commercialize zetomipzomib in Greater China, South Korea and Southeast Asia. 
• LN is the most common secondary immune-mediated glomerular disease, which may gradually lead to kidney failure.  There are an estimated 400,000-600,000 LN patients in China.

Words From Leaders 

1. Everest Medicines’ CEO

• "With the approval of the zetomipzomib IND in China, Everest now has three medicines in the renal space either commercialized 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,"" said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. 
• "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. We look forward to working closely with Kezar on enrolling the PALIZADE trial and furthering Everest's leadership position in renal and autoimmune diseases in Asia."

2. Kezar’s CEO

"This important milestone demonstrates that Everest is the ideal regional partner for Kezar in our efforts to develop zetomipzomib,"" said Christopher Kirk, Ph.D., Chief Executive Officer of Kezar. ""We will continue to work with the outstanding team at Everest to help drive enrollment in PALIZADE and get zetomipzomib to even more patients in need in Asia."

About PALIZADE

• PALIZADE is a global, placebo-controlled, randomized, double-blind Phase 2b clinical trial evaluating the efficacy and safety of two dose levels of zetomipzomib in patients with active LN. 
• Target enrollment will be 279 patients, randomly assigned to receive 30 mg of zetomipzomib, 60 mg of zetomipzomib or placebo subcutaneously once weekly for 52 weeks, in addition to standard background therapy. 
• Background therapy can, but will not be mandated to, include standard induction therapy. Over the initial 16 weeks, there will be a mandatory corticosteroid taper to 5 mg per day or less. 
• End-of-treatment assessments will occur at Week 53. The primary efficacy endpoint is the proportion of patients who achieve a complete renal response (CRR) at Week 37, including a urine protein-to-creatine ratio (UPCR) of 0.5 or less without receiving rescue or prohibited medications. 

About Zetomipzomib

• 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.
• 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.

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information

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