Bayer has linked asundexian to a 26% reduction in stroke in a phase 3 study, setting the bar for Bristol Myers Squibb and Johnson & Johnson’s rival factor XIa inhibitor in a blockbuster indication.
The German drugmaker reported the study met its primary endpoint in November, providing a boost for the program and factor XIa inhibition more broadly after setbacks to asundexian and BMS and J&J’s rival drug candidate milvexian. Yet the lack of data in Bayer’s top-line release left unanswered questions about the clinical significance of the statistical success.
Bayer answered the questions Thursday, using the International Stroke Conference 2026 in New Orleans to present data from the trial. The headline finding is that asundexian cut ischemic stroke by 26% after a noncardioembolic ischemic stroke or high-risk transient ischemic attack (TIA), also called a mini-stroke.
On an earnings call in May, Stefan Oelrich, head of Bayer’s pharma division, said the company focused the phase 3 trial on the subgroup in which it saw the biggest effect in phase 2. The company reported a 36% reduction in the risk of recurrent symptomatic ischemic stroke and TIA in the phase 2 subgroup. For comparison, BMS and J&J saw a 30% relative risk reduction in symptomatic ischemic strokes in their phase 2 trial.
Asundexian reduced the stroke rate in the phase 3 trial without increasing major bleeding, which affected 1.9% of people on the study drug and 1.7% of their counterparts on placebo. Bayer said the risks of minor bleeding, hemorrhagic stroke, symptomatic intracranial hemorrhage and fatal bleeding were similar on asundexian and placebo.
The potential to clear clots without raising bleeding risk is central to the promise of factor XIa inhibitors. While other anticoagulants affect hemostasis and thrombosis, factor XIa inhibition could decouple the mechanisms to deliver at least comparable efficacy and better safety than existing treatments.
Bayer reported the phase 3 trial met multiple secondary endpoints, including by linking asundexian to a 26% reduction in the risk of a stroke of any kind compared to placebo. The secondary analysis included hemorrhagic strokes. Bayer also hit a composite endpoint of cardiovascular death, myocardial infarction (MI) or stroke as well as the composite of death from any cause, MI or stroke.
Ashkan Shoamanesh, M.D., the trial’s co-principal investigator, said in a statement that the consistent reduction in secondary events with asundexian across all types of strokes is particularly striking. The results provide confidence that asundexian, if approved, could be an important option for secondary stroke prevention across a broad range of patients, Shoamanesh said.
At the J.P. Morgan Healthcare Conference in January, Bayer's Oelrich said the pharma was engaging with health authorities and aiming to win approval this year. The timeline would put Bayer “well ahead of any competitor in this space, which will allow us to clearly set the scene and once again prove what I call our secret sauce in cardiovascular because we believe that we're a true leader in this space,” Oelrich said.
BMS and J&J expect to publish phase 3 results for milvexian in secondary stroke prevention in the second half of 2026. The companies are gearing up to compete for a stroke market that Guggenheim Securities analysts valued at $3 billion to $4 billion in a note to investors in November. The analysts estimated atrial fibrillation, where Bayer has already failed, is a $15 billion opportunity.
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