• 05 Dec 2023
• Admin
• News Article

China NMPA accepts Everest Medicines IND application for zetomipzomib to treat a range of immune-mediated disorders

Everest Medicines, a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, 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.

"The IND acceptance of zetomipzomib marks an important step towards entering clinical studies in China. We look forward to participating in the PALIZADE trial to enroll LN patients in the nation which has a high prevalence of the disease," said Rogers Yongqing Luo, chief executive officer of Everest Medicines. "Renal and autoimmune diseases are key therapeutic areas for Everest, and zetomipzomib represents another mid-to-late-stage pipeline asset that will solidify our leading position in these therapeutic areas in Asia."

Zetomipzomib demonstrated positive results from an earlier phase 2 trial, with clinically meaningful overall renal response rate of 64.7% at Week 25 (end of treatment) and 88.2% at Week 37. Complete renal response rate was 35.3% at Week 25 and 41.2% at Week 37. 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 favourable safety and tolerability profile during the trial with no new safety signals during the follow-up period.

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 favourable safety and tolerability profile 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 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. 

Everest Medicines is a biopharmaceutical company focused on developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets.