Pharma Focus Asia

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

Tuesday, February 27, 2024

Today, Everest Medicines (HKEX: 1952.HK) and Kezar Life Sciences, Inc. (Nasdaq: KZR) announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved Kezar’s investigational new drug (IND) application. This approval allows for the initiation of the Phase 2b PALIZADE trial in China, focusing on zetomipzomib for patients with lupus nephritis (LN). Zetomipzomib is a novel, first-in-class, selective immunoproteasome inhibitor with potential therapeutic applications across various autoimmune diseases.

Everest will join Kezar in enrolling patients in China for the ongoing PALIZADE trial. This trial, a global endeavor, is a placebo-controlled Phase 2b clinical study designed to assess the efficacy and safety of two different doses of zetomipzomib, alongside a placebo, in patients with active LN. In September 2023, Everest secured exclusive rights for the development and commercialization of zetomipzomib in Greater China, South Korea, and Southeast Asia. LN, being the most prevalent secondary immune-mediated glomerular disease, poses a significant threat of kidney failure, affecting an estimated 400,000-600,000 individuals in China alone.

Everest Medicines, expressed enthusiasm regarding this development, highlighting Everest's expanding portfolio in renal therapeutics and its commitment to addressing critical unmet medical needs in LN. Leveraging their expertise in clinical development, regulatory affairs, and commercial infrastructure, Everest aims to advance the development of zetomipzomib and reinforce its leadership in renal and autoimmune diseases across Asia.

Kezar, emphasized the significance of Everest as a regional partner in the development of zetomipzomib, underscoring their collaborative efforts to extend the reach of this potential treatment to patients in Asia.

The PALIZADE trial is a comprehensive endeavor, aiming to enroll 279 patients globally. Participants will be randomly assigned to receive either 30 mg or 60 mg of zetomipzomib or a placebo subcutaneously once weekly for 52 weeks, alongside standard background therapy. The primary endpoint of the trial is the proportion of patients achieving a complete renal response (CRR) at Week 37, measured by a urine protein-to-creatinine ratio (UPCR) of 0.5 or less without the need for rescue or prohibited medications.

Zetomipzomib, also known as KZR-616, holds promise as a therapeutic agent for severe, chronic autoimmune diseases, supported by preclinical and clinical data demonstrating its favorable safety profile and tolerability.

In summary, the approval of zetomipzomib's IND in China marks a significant step forward in addressing the unmet medical needs of LN patients, with Everest and Kezar collaborating to bring this potential treatment to fruition.

 

Source: everestmedicines.com

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