In the race for safer anticoagulants, Anthos Therapeutics thinks it has a winner. New data published in the NEJM show that its dual-acting Factor XI/XIa inhibitor abelacimab reduced major or clinically relevant non-major bleeding by 62% compared to Xarelto (rivaroxaban) in patients with atrial fibrillation (AFib).
The company previously reported that the Phase II AZALEA-TIMI 71 trial, which was stopped early due to "overwhelming" benefit, had shown that monthly subcutaneous doses of abelacimab led to a substantial 67% lower risk on the combined primary endpoint of major or clinically relevant non-major bleeding.
"Many doctors are put in the unfortunate position of having to weigh the risk of stroke against the risk of bleeding for their patients with AFib," said principal investigator Christian Ruff in a company release Wednesday. "This study reinforces the promise of abelacimab as a potentially safer alternative to current anticoagulants."
Anthos said abelacimab also achieved a median 99% inhibition of Factor XI sustained over two years. In addition, the study showed a 67% reduction in major bleeding alone and an 89% reduction in gastrointestinal bleeding compared to daily Xarelto.
The success of abelacimab as well as a similar drug — Bristol Myers Squibb and Johnson & Johnson's oral Factor XIa inhibitor milvexian — have been a counterweight to Bayer's ill-fated asundexian. The surprise failure of Bayer's drug, another oral Factor XIa programme, in the Phase III OCEANIC-AF trial in late 2023 led it to being stopped early due to inferior efficacy versus BMS's Eliquis (apixaban).
Abelacimab's long half-life and clean bleeding profile could translate to clinical advantages versus direct oral anticoagulants (DOACs), Ruff suggested in a recent FirstWord interview.
In a physician poll, FirstWord found that 89% of cardiologists described abelacimab's clinical profile as "impressive," compared to current DOACs. Anthos estimates that 40-60% of AFib patients currently either receive insufficient doses or forgo anticoagulation altogether due to concerns about bleeding.
"Building on the overwhelmingly positive data from the AZALEA study, data on the safety of abelacimab in patients undergoing surgical procedures as well as data in patients taking antiplatelet therapy further reinforce the fundamental premise of the promise of Factor XI inhibition — the potential to prevent thrombotic events without affecting normal haemostasis," said Dan Bloomfield, chief medical officer at Anthos.
Currently, the Phase III LILAC-TIMI 76 study, which got underway in 2023, is evaluating abelacimab against placebo in AFib patients deemed unsuitable for conventional anticoagulations. That study is expected to wrap in the second half of 2026.
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