Updated Version 1 - Correction - Amgen's autoimmune disease drug succeeds in late-stage clinical trial

Added stock information in paragraph 1 and analyst comments in key points 5 and 9.

Christy Santhosh

Reuters, September 22 - Amgen (AMGN.O) said on Tuesday that its experimental drug for treating an autoimmune disease that attacks the body's exocrine glands met its primary endpoint of reducing disease activity in a late-stage trial. Boosted by this news, the company's shares rose 4% in early trading.

Details are as follows:

• At week 48, the drug dazodalibep showed statistically and clinically significant improvement in disease activity for patients with moderate to severe Sjögren's syndrome.

• Sjögren's syndrome causes widespread dryness in the eyes, mouth, and other parts of the body, along with fatigue and chronic pain.

• According to the U.S. National Institutes of Health, the disease affects about 1% of the global population and primarily impacts women.

• Amgen stated that most adverse events in the trial were mild to moderate, with only a few patients discontinuing treatment.

• William Blair analyst Matt Phipps said that, given the high risks and research challenges in treating Sjögren's syndrome, including a high placebo response rate, the trial results are encouraging.

• Novartis (NOVN.S) and Johnson & Johnson (JNJ.N) are also developing drugs for Sjögren's syndrome, and currently there are no approved treatments for the condition in the U.S.

• However, analysts noted that several key details important to investors were missing from the announcement and emphasized that the full trial results need to be compared with Novartis's ianalumab. Amgen plans to present detailed data at an upcoming medical meeting.

• The company is also testing the drug in another clinical trial called OASIZ 303 for patients with moderate to severe symptom burden due to Sjögren's syndrome, with results expected in Q4 2026.

• Phipps expects that two positive late-stage study results will be needed to secure U.S. Food and Drug Administration (FDA) approval for the drug in treating Sjögren's syndrome; Amgen will likely outline its regulatory and submission plans after the OASIZ 303 results are announced.

(To facilitate non-native English speakers, Reuters provides automated translations of its reports in several other languages. Due to potential errors in automated translation or lack of required context, Reuters does not guarantee the accuracy of the automated translation and provides it for reader convenience only. Reuters assumes no responsibility for any damages or losses resulting from use of this automated translation feature.)