- 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.
