Positive late-breaking results from Phase II AXIOMATIC-SSP study of milvexian

Results from the Phase II AXIOMATIC-SSP dose-ranging study of the investigational oral factor XIa (FXIa) inhibitor, milvexian, were released on Sunday in a Hot Line session at the European Society of Cardiology (ESC) Congress 2022, by Bristol Myers Squibb (NYSE: BMY) and its partner Janssen Pharmaceuticals, a part of US healthcare giant Johnson & Johnson (NYSE: JNJ).

The trial showed an approximate 30% relative risk reduction in recurrent symptomatic ischemic strokes and favorable safety profile in three arms compared to placebo when used in combination with background antiplatelet therapy in patients with an acute non-cardioembolic ischemic stroke or transient ischemic attack.

The primary objective of this study was to detect a dose response for the composite endpoint of symptomatic ischemic stroke + MRI detected covert brain infarction across a 16-fold dose range; a dose response was not observed. A relative risk reduction of approximately 30% in symptomatic ischemic stroke with milvexian was observed in patients receiving either 25, 50 or 100mg twice daily compared to placebo.