Amgen's Dazodalibep Scores Big Win in Sjögren's Disease Trial
Biotech giant Amgen has announced that its experimental treatment dazodalibep has met its primary endpoint in a Phase 3 trial for adults with Sjögren's disease. The study, known as OASIZ 301, showed statistically significant improvement at Week 48 as measured by the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI). This means that dazodalibep was able to reduce symptoms of the autoimmune disorder, which affects millions worldwide.
The study enrolled approximately 621 patients with moderate-to-severe systemic disease activity and found improvements in symptoms as early as Week 4. The most common side effects reported were nasopharyngitis, urinary tract infection, hypertension, and infusion-related reactions. These events were generally mild to moderate in nature and did not lead to any serious complications.
Amgen plans to present detailed data from the study at an upcoming medical meeting and is expected to complete its Phase 3 OASIZ 303 trial in the fourth quarter of 2026. Dazodalibep works by disrupting interactions between T cells, B cells, and other antigen-presenting cells, making it a potential game-changer for patients with Sjögren's disease.