The FINANCIAL — Portola Pharmaceuticals and Merck on March 15 announced the results of EXPLORE-Xa, a Phase 2 exploratory, dose finding study of betrixaban, an investigational oral direct Factor Xa inhibitor. Results showed that a once-daily dose of oral betrixaban, given to patients with non-valvular atrial fibrillation or atrial flutter and at least one risk factor for stroke, reduced the incidence of major and clinically relevant non-major (CRNM) bleeds compared to dose-adjusted warfarin.
The data were presented during a late-breaking clinical trials session at the American College of Cardiology (ACC) 59th Annual Scientific Session in Atlanta.
"Given that bleeding can be a significant safety issue for patients who take warfarin, there is a critical unmet need for anticoagulant therapy options," said U.S. national coordinator in the study, Michael Ezekowitz, MB, ChB, DPhil, vice president of the Lankenau Institute for Medical Research and professor at Jefferson Medical College. "The EXPLORE-Xa study accomplished its objective of providing important information to guide the betrixaban dosing strategy for future investigational studies."
In this multinational, dose-finding study of 508 patients with non-valvular atrial fibrillation or atrial flutter and at least one risk factor for stroke, a once daily dose of betrixaban 40 mg (n=127) demonstrated significantly less major and CRNM bleeding than open label warfarin (n=127, p=0.035). The risk of major and CRNM bleeding for the 60 mg (n=127) and 80 mg (n=127) doses of betrixaban was similar to warfarin.
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