A large study finds that the investigational drug asundexian reduces recurrent stroke risk by 26% in patients who recently experienced a stroke or temporary blockage of blood flow.
RT’s Three Key Takeaways:
- Reduced Recurrent Stroke Risk: The OCEANIC-STROKE trial demonstrated that asundexian reduced the occurrence of ischemic stroke by 26% compared to a placebo.
- Safety Profile: Unlike traditional anti-clotting treatments, the Factor XIa inhibitor did not increase the risk of major bleeding or other serious side effects.
- Novel Mechanism of Action: The medication works by targeting Factor XIa, a protein involved in harmful clot formation that plays only a minimal role in the body’s natural bleeding control.
An international study found that Bayer AG’s asundexian, an investigational anti-clotting medication, reduces the risk of stroke in people who recently experienced a noncardioembolic stroke or transient ischemic attack (TIA) without increasing bleeding risk, according to findings from the OCEANIC-STROKE trial published in The New England Journal of Medicine (NEJM).
The study involved 12,327 adults from 37 countries who were enrolled within 72 hours of a stroke or a temporary blockage of blood flow to the brain.
Currently, secondary prevention for these patients relies primarily on antiplatelet medications. These existing treatments reduce risk only modestly and often increase the risk of bleeding when used long term or in combination.
“This is something researchers have been working toward for decades,” said Mike Sharma, principal investigator of the study and a senior scientist at the Population Health Research Institute (PHRI), in a news release. “Asundexian reduced the occurrence of a stroke by 26 per cent, and this benefit was consistent across patients of different ages, sexes, stroke severity, and stroke causes, without increasing major bleeding or other serious side-effects.”
In the trial, participants were randomly assigned to receive either 50 mg of asundexian once daily or a placebo, in addition to standard antiplatelet therapy such as aspirin. The average age of participants was 68 years, and 95% had experienced a non-cardioembolic stroke.
Researchers found that 2% of patients taking asundexian experienced another ischemic stroke, compared with 8.4% of those taking a placebo. Disabling or fatal strokes occurred in 2.1% of patients in the asundexian group versus 3% in the placebo group, representing a 31% reduction. Notably, no increase in bleeding was observed in patients receiving the investigational drug.
Asundexian works by blocking Factor XIa, a protein involved in harmful clot formation. While Factor XIa contributes to dangerous clots, it plays only a small role in the body’s ability to stop bleeding. By targeting this protein, the medication aims to prevent strokes while preserving natural bleeding control.
“Until now, reducing stroke risk has often been associated with higher bleeding risk. These findings give us hope for a safer way to prevent recurrent strokes,” said Ashkan Shoamanesh, co-principal investigator of the study and PHRI senior scientist, in a news release.
OCEANIC-STROKE is the first completed Phase 3 trial of a Factor XIa inhibitor for secondary stroke prevention. Previous efforts to develop long-term secondary prevention therapies have often failed due to a lack of efficacy, increased bleeding complications, or both.
Asundexian is currently under regulatory review and is not yet approved for clinical use.
