Everest Medicines Announces First Chinese Patient Dosed in Global Phase 2b PALIZADE Trial of Zetomipzomib in Lupus Nephritis

SHANGHAI, July 22, 2024 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing and commercialization of innovative therapeutics, today announced that the first Chinese patient has been dosed with zetomipzomib in the global Phase 2b PALIZADE trial for the treatment of active lupus nephritis (LN). Zetomipzomib is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases.

"This is another milestone following the investigational new drug (IND) application approval by China's National Medical Products Administration (NMPA) this February. LN is the most common secondary immune-mediated glomerular disease, which may gradually lead to kidney failure. There are approximately 400,000-600,000 LN patients in China, highlighting the significant unmet clinical need," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "Leveraging our strengths in clinical development, regulatory filing, and commercialization, we will accelerate its development to benefit patients in China as soon as possible. Renal diseases and autoimmune diseases are key therapeutic areas for Everest. The Company currently has three nephrology drugs in commercialization or clinical development stages. We will continue to advance the clinical development pipeline to reinforce our leadership in the fields of nephrology and autoimmune disease treatment in Asia."

In China, the 10-year renal survival rate of LN is 81% to 98%, making it a common cause of end-stage renal disease (ESRD) and a significant contributor to mortality in SLE patients. Despite recent advances in LN treatment options including the application of new immunosuppressive regimens, especially multi-targeted therapies, the flare rate of LN remains high (33% to 40%), leading to chronic kidney damage and progression to ESRD. Treatment-related complications, such as infections, diabetes, femoral head necrosis, and ovarian failure, are also important factors contributing to the decline in quality of life of SLE patients.

Everest joined Kezar Life Sciences ("Kezar") on PALIZADE, a global, placebo-controlled Phase 2b clinical trial evaluating the efficacy and safety of two dose-levels of zetomipzomib in patients with active LN. PALIZADE was initiated in mid-2023. In September 2023, Everest obtained exclusive rights to develop and commercialize zetomipzomib in Greater China, South Korea and Southeast Asia. In addition to LN, Everest and Kezar have the opportunity to collaborate on the development of zetomipzomib in other autoimmune diseases such as SLE and autoimmune hepatitis.

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, please visit its website at www.everestmedicines.com.

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