Amgen announced positive topline results from its Phase 3 OASIZ 301 study for dazodalibep. The investigational treatment for Sjögren's disease met its primary endpoint in adults with moderate-to-severe systemic activity. The trial demonstrated statistically significant and clinically meaningful improvement at 48 weeks. These improvements were observed as early as week four and sustained throughout the study.
Dazodalibep is a potential first-in-class CD40L antagonist acquired through Amgen's purchase of Horizon Therapeutics. There are currently no FDA-approved therapies for systemic Sjögren's disease activity. The drug was generally well-tolerated with mostly mild to moderate adverse events.
Amgen shares rose in premarket trading following the announcement. The company plans to present detailed study data at a future medical meeting. A second Phase 3 study for patients with lower systemic disease activity is expected to finish in the fourth quarter of 2026.