Amgen’s dazodalibep delivers phase 3 win in Sjögren’s disease

Amgen reported positive phase 3 results for dazodalibep (a CD40L fusion protein) in Sjögren’s disease (OASIZ 301), showing a significant improvement in systemic disease activity (ESSDAI) after 48 weeks versus placebo in ~651 patients. The primary endpoint was met; common adverse events included mild/moderate nasal inflammation, urinary tract infection, hypertension and infusion reactions. Detailed results will be presented at a medical conference. OASIZ 303 is ongoing with patients having milder systemic disease, and long-term extension studies are available. Analysts note two positive phase 3 reads are typically needed for FDA approval; broader industry context includes other Sjögren’s programs and Horizon/Amplitude activity and past drug withdrawals.