Amgen Dazodalibep Trial Success Puts Sjögren's Disease Treatment on Track

Amgen's Phase III Sjögren's disease trial has met its primary endpoint, marking a significant milestone in the development of treatments for this complex autoimmune disorder. The double-blind, randomized, placebo-controlled study involved patients treated with dazodalibep and demonstrated a statistically significant and clinically meaningful reduction in systemic disease activity as measured by the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) after 48 weeks.

Improvements were observed as early as week four, and the most common adverse events included nasopharyngitis, urinary tract infection, hypertension, and infusion-related reactions, which were generally mild to moderate in nature. The Sjögren's Foundation noted that Sjögren's disease is a relentless condition that creates a significant burden for patients, affecting their quality of life.

Amgen plans to present detailed data from the OASIZ 301 study at an upcoming medical meeting and is also conducting another Phase III trial (OASIZ 303) expected to be completed in Q4 2026. Dazodalibep, a potential first-in-class CD40L antagonist fusion protein, targets immune activation by disrupting interactions between T cells, B cells, and antigen-presenting cells.

Amgen acquired dazodalibep as part of its $27.8bn buyout of Horizon Therapeutics in 2023. Sjögren's disease is a systemic autoimmune disorder with symptoms including extensive dryness, profound fatigue, chronic pain, major organ involvement, neuropathy, and an increased risk of lymphoma. Currently, there are no FDA-approved medicines for Sjögren's disease.