Portola

Portola Pharma And Merck Announce Results Of EXPLORE-Xa - Quick Facts

(RTTNews) - Portola Pharmaceuticals and Merck & Co. Inc. (MRK: News ) 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 or CRNM bleeds compared to dose-adjusted warfarin.

The primary study endpoint was the time to occurrence of major or CRNM bleeding. The incidence (crude rates) of major or CRNM bleeding was 0.8 percent, 3.9 percent, 3.9 percent and 5.5 percent for the betrixaban 40 mg, 60 mg, and 80 mg and warfarin groups, respectively.

The secondary endpoints included the time to occurrence of any bleeding (major, CRNM, and minimal) and the time to occurrence of death, stroke (ischemic or hemorrhagic), myocardial infarction, or other systemic embolism.

by RTT Staff Writer

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