Bayer presents positive results from first Phase 2b trial on safety of asundexian in patients with atrial fibrillation

Bayer announced on 3 Apr 2022 the positive data from the PACFIC-AF trial which compared the safety of the investigational, oral Factor XIa (FXIa) inhibitor asundexian with apixaban (a non-vitamin K antagonist oral anticoagulant) in patients with atrial fibrillation (AF). The results found that the bleeding rate for the primary endpoint (ISTH major and clinically relevant non-major bleeding) was reduced by 67% (incidence proportion of 0.33) in patients receiving asundexian compared to those receiving apixaban. By selectively modulating coagulation, once-daily FXIa inhibitor asundexian is being investigated to become a new treatment option in thrombosis prevention. The findings were presented on 3 Apr 2022 at the American College of Cardiology's 71st Annual Scientific Session (ACC.22), and simultaneously published in The Lancet. PACIFIC-AF is the first head-to-head trial to compare the bleeding risk of an oral FXIa inhibitor vs a non-vitamin K antagonist oral anticoagulant (NOAC) in patients with AF who are at risk of stroke. The trial's primary objective was to determine whether treatment with asundexian can lead to a lower incidence of ISTH major and clinically relevant non-major bleeding when compared with apixaban in patients with AF. It also aimed to determine the optimal dose of asundexian, 20 mg or 50 mg once-daily, in these patients. This trial was not powered to discern or test differences in the rates of thrombotic events. Original source: Bayer, website:http://www.bayer.com/, Copyright Bayer AG 2022.
research and development; anticoagulants; apixaban; asundexian; cardiovascular drugs; [...]