Bayer reveals data behind asundexian's stroke win

Giving Bayer's oral Factor XIa inhibitor asundexian to people who have suffered an ischaemic stroke can reduce the risk of them having another by around a quarter.

That is the conclusion of the OCEANIC-STROKE study, which compared a 50 mg daily dose of asundexian to placebo- given on top of antiplatelet therapy – in more than 12,300 people who had experienced a non-cardioembolic ischaemic stroke or high-risk transient ischaemic attack (TIA) or 'mini-stroke'.

Bayer first reported topline findings from the phase 3 study last year and has now presented the full data at the International Stroke Conference (ISC) in New Orleans.

The results throw a lifeline to asundexian, whose future was thrown into doubt when it previously failed a phase 3 trial in atrial fibrillation (AF), and mean that Bayer can press ahead with plans to file the drug for regulatory approvals. The FDA has awarded a fast-track designation for asundexian for secondary stroke prevention.

The full results reveal a 26% fall in the risk of a secondary stroke compared to placebo, with no increase in the risk of major bleeding complications, which are a perennial concern for anti-clotting therapies.

Moreover, the drug was also able to reduce the risk of a composite endpoint of cardiovascular death, myocardial infarction (MI) or stroke, as well as death from any cause, MI or stroke, according to Bayer.

"A stroke is a life-changing event for patients and a major public health burden," said OCEANIC-STROKE's lead investigator Mike Sharma of McMaster University.

"The findings from OCEANIC-STROKE are a notable research achievement," he added. "For clinicians and researchers who have spent decades working to reduce the global burden of secondary stroke, the OCEANIC-STROKE results represent the kind of scientific progress the field has long been striving to achieve."

According to Bayer, there are around 12 million strokes recorded every year worldwide, and up to a third of them will be a recurrent stroke. Despite current secondary prevention options like aspirin and clopidogrel, one in five patients having an ischaemic stroke will have another within the next five years, with the risk of death rising sharply the second time around.

Bayer is vying to be first to market in the oral Factor XIa category against Bristol Myers Squibb and Johnson & Johnson, which are running phase 3 trials of their AF and stroke trials for their milvexian candidate, but reported disappointing results in acute coronary syndromes (ACS).

Other Factor XIa-targeting drugs coming through the industry pipeline include two antibody-based therapeutics, namely Novartis/Anthos' abelacimab, in phase 3 for prevention of stroke and systemic embolism in patients with AF, and MSD/Adimab's MK-2060, which reached phase 2 but no longer appears in its pipeline listing.

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