Bayer initiates landmark Phase III study program on oral FXIa inhibitor asundexian
German drug major Bayer (BAYN: DE) has announced the start of a Phase III clinical development program OCEANIC to investigate the efficacy and safety of asundexian, an oral Factor XIa (FXIa) inhibitor, as a potential new treatment in patients with atrial fibrillation and in patients with a non-cardioembolic ischemic stroke or high-risk transient ischemic attack.
The initiation of the OCEANIC program is based on the data from the Phase II PACIFIC program, which were presented at the European Society of Cardiology.
Asundexian 50mg administered to post-myocardial infarction patients inhibits factor XIa by more than 90% with no significant increase in bleeding, according to late breaking research presented in a Hot Line session on Sunday at ESC Congress 2022 taking place in Barcelona, Spain.
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