China NMPA Approves Everest Medicine's Zetomipzomib IND for Immune

India Pharma Outlook Team | Tuesday, 05 December 2023

 India Pharma Outlook Team

Everest Medicines, a biopharmaceutical company focused on the development, production and commercialization of innovative medicines and vaccines, announced that China's National Medical Products Administration (NMPA) has approved an investigational new drug (IND) application for zetomipsomib in China. Zetomipzomib is a novel, first-in-class, selective immunoproteasome inhibitor currently being evaluated for several immune-mediated diseases, 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 zetomipsomib in patients with active LN. LN is the most common secondary immune-mediated glomerular disease that can gradually lead to renal failure.

There are about 400,000 to 600,000 LN patients in China. The IND approval of zetomipsomib is an important step towards the start of clinical trials in China. We look forward to participating in the PALIZADE trial to enroll patients with LN in a country with a high incidence, said Rogers Yongqing Luo, CEO of Everest Medicines. Intestinal and autoimmune diseases are key therapeutic areas for Everest, and zetomipsomib is another mid- to late-stage pipeline that strengthens our leadership in these therapeutic areas in Asia.

Zetomipzomib showed positive results from an earlier phase 2 study with a clinically significant renal response of 64.7% at week 25 (end of therapy) and 88.2% at week 37. Complete renal response was 35.3% at week 25 and 41.2% at week 25. 37th week. Mean decreases from baseline in urinary protein creatinine ratio (UPCR) were 57.0% at week 25 and 83.0% at week 37, while estimated glomerular filtration rate (eGFR) remained stable during treatment. Zetomipzomib also had a favorable safety and tolerability profile during the study, with no new safety signals emerging during the follow-up period.

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