Amgen announced positive topline results from its Phase 3 OASIZ 301 study for dazodalibep in adults with moderate-to-severe systemic Sjögren's disease. The 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). Improvements in ESSDAI were observed as early as Week 4 and sustained throughout the 48-week study period.
Sjögren's disease is a systemic autoimmune condition with no currently FDA-approved treatments, making these results an important step forward. The disease can cause extensive dryness, profound fatigue, chronic pain, major organ involvement, neuropathy, and an increased risk of lymphoma. Dazodalibep is a potential first-in-class CD40L antagonist fusion protein designed to disrupt immune activation by targeting interactions between T cells, B cells, and other antigen-presenting cells.
The most common adverse events reported were generally mild to moderate and included nasopharyngitis, urinary tract infection, hypertension, and infusion-related reactions. Discontinuations due to adverse events were low and balanced across treatment groups. No imbalance in thromboembolic events or opportunistic infections was observed. These results contribute to the ongoing development of treatments for Sjögren's, with dazodalibep being studied in two patient groups: those with moderate-to-severe systemic disease and those with high symptom burden but low systemic disease.
