Amgen's autoimmune drug succeeds in late-stage trial

Sept 22 — 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.

(Reporting by Christy Santhosh in Bengaluru; Editing by ​Vijay Kishore)

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