Kezar Life Sciences announced positive results from the MISSION Phase 1 study testing the investigational KZR-616 as a treatment for lupus. The presentation was at the European League Against Rheumatism (EULAR) 2019 annual meeting.
The primary goal of the study was to assess if KZR-616 is safe and well tolerated. The study also looked at the drug’s pharmacokinetics – how it moves through the body – as well as how it works, and how well it works at varying doses.
KZR-616 was well-tolerated and effective when taken at repeated doses of 45 mg and then increased to 60 mg. Patients treated with KZR-616 did not show signs of toxicity seen with other less targeted proteasome inhibitors that block protein complexes in the immune system. Consistent and broad improvement was seen across all measures of disease activity at Week 13.
“We are thrilled to share our first in patient data with KZR-616, our novel immunoproteasome inhibitor with the clinical and scientific community at the EULAR 2019 annual meeting,” said Niti Goel, MD, Kezar’s Chief Medical Officer. “We are encouraged by the early safety and efficacy data for KZR-616. Data from the Phase 1b portion of the MISSION study accomplished our primary goal of enabling the identification of active and well-tolerated doses that meet target levels of immunoproteasome inhibition and further supports the development of KZR-616 in lupus nephritis and other autoimmune diseases of high unmet need. To that end, the Phase 2 portion of the MISSION study in patients with lupus nephritis has been initiated, and we look forward to commencing Phase 2 trials with KZR-616 in additional indications later this year.”