By Christy Santhosh
Sept 22 (Reuters) – 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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