May 6 (Reuters) – Bayer’s experimental blood thinner reduced both the frequency and severity of recurrent ischaemic strokes in a large phase III trial, without increasing the risk of serious brain bleeds, the company said on Wednesday.
Reporting more details on a trial it reported to be a success in November, the German drugmaker said that 6.2% of patients taking drug candidate asundexian experienced another ischaemic stroke, compared with 8.4% in the placebo group.
Additionally, strokes that occurred in the asundexian group were less likely to be moderate to severe in the study involving 12,327 patients.
There were also fewer cases of disability-causing and fatal strokes, as well as emergency interventions, such as clot-busting drugs or mechanical clot removal.
Bayer is betting on asundexian to offset declining revenue from older blockbuster drugs, such as its blood thinner Xarelto, which has faced competition from cheaper generics after losing patent protection. However, the company refrained from providing a peak sales estimate for the experimental drug, which it has previously described as having blockbuster potential.
The detailed trial results come after a setback in 2023, when asundexian failed to prevent first strokes in atrial-fibrillation patients during an earlier trial.
Addressing a common concern about side effects of anticoagulant drugs, the latest study also showed that the rates of intracranial bleeding and bleeding strokes were low and comparable between the asundexian and placebo groups, including among high-risk patients, Bayer said.
The company stated that it is in discussions with health authorities globally regarding regulatory approval for asundexian. According to the World Health Organization, stroke is the third-leading cause of death and disability worldwide, with the lifetime risk of stroke increasing by 50% over the past two decades.
Bayer faces competition from rivals, including Novartis with abelacimab and a joint effort by Bristol Myers Squibb and Johnson & Johnson developing milvexian, both of which have yet to report late-stage stroke-prevention data.
(Reporting by Patricia Weiss, writing by Linda Pasquini, Kirsti Knolle;Editing by Ludwig Burger and Elaine Hardcastle)
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