Bengaluru: Germany’s Bayer AG said on Sunday it is cancelling a phase III study program to investigate the efficacy and safety of asundexian, an oral Factor XIa (FXIa) inhibitor.
The decision to stop the study is based on the recommendation by the Independent Data Monitoring Committee (IDMC). IDMC monitoring showed an inferior efficacy of asundexian compared to the control arm of the study.
“A phase III study investigating asundexian compared to Apixaban in patients with atrial fibrillation at risk for stroke is being stopped early,” the company said in a statement.
Bayer, which initiated the study in August 2022, said it will further analyse the data to understand the outcome and will take appropriate measures.
Earlier this month, Bayer said it is considering separating either the non-prescription medicines business or the agriculture business from the rest of the group which includes pharmaceuticals.
