Amgen's Dazodalibep Shows Promise in Late-Stage Trial for Sjogren's Disease

Pharmaceutical company Amgen announced positive results from its late-stage trial of experimental drug dazodalibep, which treats Sjogren's disease. The condition affects about 1% of the global population and causes dryness in the eyes, mouth, and other parts of the body, along with fatigue and chronic pain.

In a statement, Amgen said that dazodalibep met the main goal of reducing disease activity in patients with Sjogren's disease who had moderate-to-severe symptoms at week 48. Most adverse events in the trial were mild to moderate, with few patients discontinuing treatment.

William Blair analyst Matt Phipps said that the trial results were encouraging given the high risk and development challenges associated with treating Sjogren's disease. However, analysts noted that several details important to investors were absent from the announcement, including full trial results and a comparison against Novartis' ianalumab.

Amgen plans to present detailed data from the trial at an upcoming medical meeting and is also testing dazodalibep in another trial, OASIZ 303, with results expected in the fourth quarter of 2026. Phipps expects two positive late-stage studies will be needed for FDA approval in Sjogren's disease.