Everest Medicines announced that China National Medical Products Administration (NMPA) has accepted its investigational new drug (IND) application for zetomipzomib in China. Zetomipzomib is a novel, first-in-class, selective immunoproteasome inhibitor currently being evaluated for a range of immune-mediated disorders, including lupus nephritis (LN). Everest plans to join its partner, Kezar Life Sciences, in 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.

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. Mean reduction in urine protein creatinine ratio (UPCR) from baseline was 57.0% at week 25 and 83.0% at week 37, while estimated glomerular filtration rate (eGFR) remained stable during treatment.

ZetomipzOMib also showed a favorable safety and tolerability profile during the trial with no new safety signals during the follow-up period. Zetomipzemib (KZR-616) is a novel, first- in-class, selective immunop proteasome 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 zetomipzomab exhibits a favorable safety and tolerability profiles for development in severe, chronic autoimmune diseases. PALIZADE is a global, placebo-controlled, randomized, double-blind Phase 2b clinical trial evaluating The efficacy and safety of two dose - levels of zetomipZR-616) is an novel, first-in- class, selective immunoproteas genome inhibitor with broad therapeutic potential across across multiple autoimmune diseases. Pre clinical research demonstrates that selective immunop proteasome inhibition results in a wide anti-inflammatory response in animal model of several autoimmune diseases, while avoid immunosuppression.

Data generate from Phase 1 and Phase 2 trials provide evidence that zetOMipzomib exhibits a favorable safety and tolerable profile for development in severe, chronic chronic autoimmune diseases. PALIZade is a global, placebo- controlled, randomized, double-blind phase 2b clinical trial evaluating the safety of two dose-levels of zetomipzOMib in patients with active L N. Target enrollment will be 279 patients, randomly assigned to receive 30 mg of zetomipzomaib, 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.