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Kezar Announces Topline Results from PRESIDIO Trial of Zetomipzomib for the Treatment of Dermatomyositis and Polymyositis
Most patients saw clinically meaningful improvements in the primary endpoint measure of Total Improvement Score (TIS), but no differentiation from placebo
About this update from Kezar Life Sciences, Inc.
[{"type":"text","content":"\n\nMost patients saw clinically meaningful improvements in the primary endpoint measure of Total Improvement Score (TIS), but no differentiation from placebo was observed\n\n\n\nZetomipzomib demonstrates a favorable safety and tolerability profile, including in the PRESIDIO Open-label Extension Study where weekly zetomipzomib has been administered for up to an additional 77 weeks\n\n\n\nTopline data from MISSION Phase 2 trial of zetomipzomib in lupus nephritis (LN) is on track and expected in June 2022, consistent with previous guidance\n\n\n SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--\nKezar Life Sciences, Inc., (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, today announced topline results from the PRESIDIO Phase 2 clinical trial of zetomipzomib (KZR-616) in patients with dermatomyositis (DM) and polymyositis (PM).\n\nIn PRESIDIO, 25 patients enrolled with either DM (n=13) or PM (n=12) with active disease despite best available treatments, and 20 patients completed through end-of-treatment. During the 32-week study period, all patients received 16 weeks of zetomipzomib treatment: patients received either 45 mg of zetomipzomib or placebo subcutaneously (SC) once weekly for 16 weeks on top of standard of care, followed by a crossover to the other arm of placebo or zetomipzomib, respectively, for an additional 16 weeks. Patients continued their background therapy but could taper medications as clinically indicated. The primary endpoint of PRESIDIO was the mean change in the Total Improvement Score (TIS).\n\nTopline results of the PRESIDIO trial showed that most DM and PM patients saw clinically meaningful improvements in TIS, but zetomipzomib demonstrated no significant differentiation from placebo. At Week 16, the zetomipzomib 45 mg SC weekly group achieved a mean TIS of 25.5 versus the control group mean TIS of 25. Following cross-over, at Week 32, the arm receiving zetomipzomib beginning at Week 16 achieved a mean TIS of 32.5 versus the control group mean TIS of 31.3.\n\nSafety\n\nZetomipzomib was well tolerated over the course of the PRESIDIO trial. Adverse events were generally mild-to-moderate (Grade 1 or 2), and the most common treatment-emergent adverse events (TEAEs) were injection site reactions, which were transien...