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Kezar Provides Data Update from MISSION Study of KZR-616
Two of two patients with Lupus Nephritis saw greater than 50% reduction in proteinuriaKZR-616 demonstrates improvement on exploratory efficacy measures across
About this update from Kezar Life Sciences, Inc.
[{"type":"text","content":"Two of two patients with Lupus Nephritis saw greater than 50% reduction in proteinuriaKZR-616 demonstrates improvement on exploratory efficacy measures across seven measures of disease activity Step-up dosing drives positive safety and tolerability profile SOUTH SAN FRANCISCO, Calif., June 03, 2020 (GLOBE NEWSWIRE) -- Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing novel small molecule therapeutics to treat unmet needs in autoimmune disease and cancer, today announced updated results from the Phase 1b (Ph1b) portion of MISSION, which is evaluating the safety and tolerability of KZR-616 in patients with systemic lupus erythematosus (SLE) with and without nephritis.\n Overall, improvements were seen across seven measures of disease activity, and two of two patients with lupus nephritis (LN) experienced a greater than 50% reduction in proteinuria, a biomarker of disease severity. A positive safety and tolerability profile was observed with step-up dosing of KZR-616. The Phase 1b dataset builds on the extensive safety and tolerability testing performed in 100 healthy subjects from two Phase 1a studies. “KZR-616 is demonstrating a favorable safety and tolerability profile at doses consistent with potent and selective inhibition of immunoproteasome activity. Most strikingly, there are early and strong signs of modification of SLE disease activity, including a reduction in symptoms and biomarkers. Given the encouraging exploratory efficacy data, we are evaluating opportunities to quickly bring KZR-616 to patients with a wide array of severe autoimmune diseases,” said Noreen Henig, MD, Kezar’s Chief Medical Officer. As of the May 4, 2020 data cutoff, the Ph1b portion of MISSION enrolled 39 SLE patients across five dose cohorts evaluating 45 mg and step-up dosing to 60 mg weekly for 13 weeks. Patients are followed to week 25 and kept on stable background treatment. Below are the results for step-up dosing Cohorts 2a, 2b, and 2c, which enrolled 26 patients. At this time point, a total of 16 patients from these cohorts completed 13 weeks of treatment (10 from Cohort 2a and 6 from Cohort 2b) and are included in the exploratory efficacy measures reported below. Two SLE patients with biopsy-proven lupus nephritis were included in the Phase 1b portion. Both patients showed a greater th...