Everest Medicines, a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, today 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 favorable safety and tolerability profile during the trial with no new safety signals during the follow-up period.
