Amgen's Dazodalibep Shows Promise in Phase 3 Sjögren's Trial

Amgen announced positive topline results from its phase 3 OASIZ 301 trial of dazodalibep in adults with Sjögren disease and moderate-to-severe systemic disease activity. The primary endpoint was met at week 48, showing a statistically significant and clinically meaningful improvement.

Dazodalibep is a potential first-in-class CD40 ligand antagonist fusion protein designed to disrupt costimulatory interactions between T cells, B cells, and other antigen-presenting cells. In an earlier phase 2 trial, dazodalibep produced a 6.3-point reduction in ESSDAI score compared with a 4.1-point reduction for placebo at day 169.

The OASIZ 301 trial enrolled approximately 621 patients and was a randomized, double-blind, placebo-controlled study. The most common adverse events were nasopharyngitis, urinary tract infection, hypertension, and infusion-related reactions, generally mild to moderate in severity.