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Kezar Life's Lead Asset Fails To Top Placebo In Muscle Inflammation Disease

  • Kezar Life Sciences Inc (NASDAQ: KZR) announced topline results from the PRESIDIO Phase 2 trial of zetomipzomib (KZR-616) in patients with dermatomyositis (DM) and polymyositis (PM), chronic inflammatory diseases of muscle.

  • Topline results showed that most DM and PM patients saw clinically meaningful improvements in Total Improvement Score (TIS), but zetomipzomib demonstrated no significant differentiation from placebo.

  • At Week 16, the zetomipzomib 45 mg subcutaneously weekly group achieved a mean TIS of 25.5 versus the control group's mean TIS of 25.

  • Related: Small-cap Biopharma Kezar Life Sciences Is Soaring, Here's Why.

  • Following crossover, at week 32, the arm receiving zetomipzomib beginning at Week 16 achieved a mean TIS of 32.5 versus the control group's mean TIS of 31.3.

  • Zetomipzomib was well tolerated. Adverse events were generally mild-to-moderate, and the most common treatment-emergent adverse events were injection site reactions, which were transient and manageable.

  • One subject withdrew from the study following an injection site reaction.

  • There were three Grade 3 serious adverse events in the zetomipzomib arms, including one patient who experienced a mechanical fall and syncope and another patient who had a retinal detachment. All deemed unrelated to zetomipzomib.

  • Price Action: KZR shares closed 24.1% lower at $9.35 during after-hours trading on Tuesday.

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