Amgen's Autoimmune Drug Succeeds in Late-stage Trial

 Amgen said on Tuesday its experimental drug to treat an autoimmune disease that attacks the body's ⁠moisture-producing glands met the main goal of reducing disease activity in a late-stage trial, sending its shares up 4% ⁠in morning trading.

Here are some details:

• The drug dazodalibep showed statistically significant and clinically meaningful improvement ⁠in patients with Sjogren's disease ‌who had moderate-to-severe disease activity at week 48.

• Sjogren's disease can cause extensive dryness of the eyes, mouth and other parts of the body, along with fatigue and chronic pain.

• It affects about 1% of the global population and predominantly affects women, according to ‌the National Institutes of Health.

• Amgen said most adverse events in the ​trial were ‌mild to moderate, with few patients ‌discontinuing treatment.

• William Blair analyst Matt Phipps said the trial results were encouraging given the drug's high risk ⁠and development challenges in Sjogren's disease, including high ‌placebo response rates.

• Novartis ⁠and Johnson & Johnson are also developing ​drugs to treat Sjogren's disease, which ‌has no approved treatments in the US.

• Analysts, however, said several details that matter to investors were absent, and noted that full trial results will need to be ​compared against Novartis' ianalumab. Amgen plans to present detailed ‌data ‌from the trial at an upcoming medical meeting.

• The company is also testing the drug ‌in a separate trial, ​OASIZ 303, in Sjogren's patients with moderate-to-severe symptom burden, 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, with Amgen likely ‌to outline regulatory and filing plans after the OASIZ 303 readout.

https://www.medscape.com/s/viewarticle/amgens-autoimmune-drug-succeeds-late-stage-trial-2026a1000zb3