Amgen’s Horizon-acquired drug dazodalibep meets primary endpoint in phase 3 Sjögren’s trial

Amgen announced that its investigational fusion protein dazodalibep, acquired through Horizon Therapeutics, achieved its primary goal in a phase 3 study of patients with moderate to severe Sjögren’s disease.

The Oasiz 301 trial enrolled 651 participants and after 48 weeks the drug produced a statistically significant reduction in disease activity scores (ESSDAI) compared with placebo.

The safety profile was manageable, with the most frequent adverse events being mild to moderate nasal inflammation, urinary tract infection, hypertension and infusion-related reactions.

No therapies are currently approved by the FDA specifically for Sjögren’s, so the result represents a potential new treatment option. Detailed data will be presented at an upcoming medical conference.