Everest Medicines is on track to commence clinical trials in China for its renal disease drug candidate, following the acceptance of its investigational new drug (IND) application by the China National Medical Products Administration (NMPA).
The drug, zetomipzomib (KZR-616), is a novel immunoproteasome inhibitor designed to selectively block the immunoproteasome and rebalance the overactive immune system of lupus nephritis patients.
By laying down the clinical foundation in China, Everest will begin contributing to the global PALIZADE study being conducted by its partner Kezar Life Sciences.
The Phase IIb PALIZADE clinical trial (NCT05781750) is a randomised, double-blind, multi-centre study evaluating the safety and efficacy of the therapy for the treatment of active lupus nephritis. An estimated 279 patients will be randomly administered 30mg or 60mg of either zetomipzomib or placebo over a 52-week treatment period. The study investigates the incidence and severity of adverse events and the proportion of patients achieving complete renal response (CRR) at week 37 as primary endpoints.
Zetomipzomib demonstrated “clinically meaningful” overall renal response rates and a favourable safety and tolerability profile in Kezar’s previous open-label Phase II MISSION clinical trial (NCT03393013) evaluating zetomipzomib as a treatment for active proliferative lupus nephritis.
Kezar has, however, navigated a bumpy road to see the Phase II PALIZADE trial. After signing the collaboration and licence agreement with Everest in September—a decision that led to Everest obtaining the sole rights to develop and commercialise zetomipzomib in Greater China, South Korea, and South-East Asia—Kezar became washed up in the wave of layoffs.
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The strategic realignment plan announced by Kezar in October resulted in the company jettisoning approximately 41% of its workforce to extend the company’s cash runway into late 2026. Freed capital was directed towards Phase II PALIZADE which now has an expected topline data readout date in mid-2026.
On the other hand, Everest is coming off a series of successes. The China-based biopharmaceutical company gained NMPA approval for its primary immunoglobin A nephropathy (IgAN) therapy Nefecon for adults in November. In addition, the company’s New Drug Application (NDA) for XERAVA (eravacycline), a treatment for complicated intra-abdominal infections (cIAI), was approved for adults by the Taiwan Food and Drug Administration in September.