China NMPA Approves Phase 2b Trial for Lupus Nephritis Drug

Everest Medicines and Kezar Life Sciences have received approval from China's National Medical Products Administration (NMPA) for the Phase 2b PALIZADE clinical trial of zetomipzomib, a groundbreaking immunoproteasome inhibitor. This drug is at the forefront of treatment for lupus nephritis (LN), an autoimmune condition that can lead to kidney failure and affects an estimated 400,000 to 600,000 people in China.

The PALIZADE trial is a significant international effort, with Everest Medicines set to enroll Chinese patients alongside Kezar. The trial will assess the efficacy and safety of zetomipzomib at two dosages compared to a placebo in treating active LN. Everest Medicines secured exclusive rights to develop and market zetomipzomib in Greater China, South Korea, and Southeast Asia last September.

Rogers Yongqing Luo, CEO of Everest Medicines, expressed enthusiasm for the trial's potential to address significant medical needs for LN patients. Everest intends to apply its clinical development expertise and commercial infrastructure in China to progress zetomipzomib's development and strengthen its position in renal and autoimmune diseases in Asia.

Christopher Kirk, CEO of Kezar, highlighted Everest's pivotal role as a regional partner in advancing zetomipzomib's development. Kezar is committed to collaborating with Everest to increase patient enrollment in the PALIZADE trial and make the drug accessible to those in need across Asia.

The PALIZADE trial's design is meticulous, with a target of 279 patients who will be randomly assigned to receive either 30 mg or 60 mg of zetomipzomib or a placebo weekly for 52 weeks. The trial includes a mandatory corticosteroid taper during the first 16 weeks and will conclude with end-of-treatment assessments at Week 53. The primary goal is to measure the proportion of patients achieving a complete renal response, indicated by a urine protein-to-creatine ratio of 0.5 or lower without additional rescue medications.

Zetomipzomib (KZR-616) has shown promise as a first-in-class immunoproteasome inhibitor with the potential to treat a range of autoimmune diseases. Preclinical studies have demonstrated its broad anti-inflammatory effects without causing immunosuppression. Phase 1 and 2 clinical trials have indicated that zetomipzomib is safe and well-tolerated, making it a promising candidate for severe, chronic autoimmune conditions.

Everest Medicines is dedicated to developing transformative pharmaceutical products and vaccines for Asian markets, with a focus on renal diseases, infectious diseases, and autoimmune disorders. The company's management boasts extensive experience from both global and local pharmaceutical entities.

Kezar Life Sciences, a clinical-stage company, is developing innovative treatments for immune-mediated and oncologic disorders. Besides zetomipzomib, Kezar is also evaluating KZR-261, which targets the Sec61 translocon and protein secretion pathway, in a Phase 1 clinical trial for solid tumors.

The collaboration between Everest and Kezar signifies a significant step forward in the treatment of LN and other autoimmune diseases, offering hope to patients and contributing to the advancement of medical science in the region.