Amgen's Dazodalibep Shines Bright in Sjögren's Disease Trial with Statistically Significant Results

Amgen's experimental treatment dazodalibep has achieved positive results in a Phase 3 clinical trial for Sjögren's disease, a systemic autoimmune condition with no FDA-approved medicines currently available. The OASIZ 301 study met its primary endpoint, demonstrating statistically significant and clinically meaningful improvement at week 48 as measured by the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI). This validated tool assesses systemic disease activity across organ systems.

Improvements were observed as early as week 4 with dazodalibep treatment, a CD40L antagonist fusion protein designed to target immune activation. The asset was acquired by Amgen through its purchase of Horizon Therapeutics in 2023. Detailed results will be presented at an upcoming medical meeting.

The most common adverse events reported were nasopharyngitis, urinary tract infection, hypertension, and infusion-related reactions, which were generally mild to moderate. Discontinuations due to adverse events occurred at a low rate and were balanced across treatment groups.