Phase 2 trial of zetomipzomib for kidney inflammation OK’d in China
Sites in China add to others worldwide to test therapy for lupus nephritis
An arm of China’s National Medical Products Administration has given Kezar Life Sciences the green light to open sites in China for a Phase 2 clinical trial testing zetomipzomib in people with lupus nephritis, a severe complication of lupus characterized by kidney inflammation and damage.
Kezar will run the trial in partnership with Everest Medicines, which secured the rights to develop and commercialize zetomipzomib in China and other parts of southeast Asia last year. That deal with Kezar is worth up to $132.5 million.
“We are excited about the initiation of this clinical trial with the potential to benefit patients with [lupus nephritis] experiencing critical unmet medical needs,” Rogers Yongqing Luo, Everest’s CEO, said in a company press release.
The Phase 2 trial, PALIZADE (NCT05781750), is already up and running at more than 100 sites around the world. The study is recruiting adults diagnosed with active lupus nephritis. A full list of eligibility criteria and trial locations can be found at the study’s website.
“We intend to leverage our expertise in clinical development, regulatory filings, and our newly established commercial infrastructure in China to advance the development of zetomipzomib,” said Luo. “We look forward to working closely with Kezar on enrolling the PALIZADE trial and furthering Everest’s leadership position in renal and autoimmune diseases in Asia.”
PALIZADE trial to assess kidney inflammation benchmarks
The PALIZADE study aims to recruit 279 patients. The participants will be randomly assigned to receive 30mg or 60 mg of zetomipzomib or a placebo once weekly for about a year in addition to their regular treatments, with a mandatory reduction in corticosteroid doses to 5 mg or less over the study’s first four months.
Zetomipzomib is given via subcutaneous or under-the-skin injection. It’s designed to reduce inflammation by blocking the activity of a protein complex in immune cells called immunoproteasome. Data from a previous Phase 1b/2 study, dubbed MISSION (NCT03393013), showed the therapy was able to improve kidney function in people with lupus nephritis.
The main goal of the PALIZADE trial is to assess whether the therapy can outperform a placebo in terms of the number of patients who achieve a complete renal response — which essentially means they meet certain benchmarks of kidney health without the use of rescue or prohibited medications — after about eight months.
The trial approval from China’s Center for Drug Evaluation “demonstrates that Everest is the ideal regional partner for Kezar in our efforts to develop zetomipzomib,” said Christopher Kirk, PhD, CEO of Kezar. “We will continue to work with the outstanding team at Everest to help drive enrollment in PALIZADE and get zetomipzomib to even more patients in need in Asia,” he said.
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