Portola Initiates Phase 3 Study Of Anticoagulation Antidote Andexanet Alfa

(RTTNews) - Portola Pharmaceuticals Inc. (PTLA) Wednesday said it has initiated a Phase 3 study of andexanet alfa to evaluate the safety and efficacy of the compound with Bristol-Myers Squibb Company (BMY) and Pfizer Inc.'s (PFE) Factor Xa inhibitor Eliquis. Andexanet alfa is a potential first-in-class antidote to reverse the anticoagulation activity of Factor Xa inhibitor-treated patients who are suffering a major bleeding episode or require emergency surgery.

The randomized, double-blind, placebo-controlled study will evaluate the efficacy of andexanet alfa in reversing Eliquis-induced anticoagulation rapidly after an IV bolus and sustaining that effect through a continuous infusion.The initial data from the first part of the study, is expected in the fourth quarter, with the bolus-plus-continuous infusion data from the second part of the study expected in early 2015.

The study will look at the efficacy of andexanet alfa in healthy volunteers, aged 50 to 75, as demonstrated by biomarker endpoints, including anti-Factor Xa levels, plasma free fraction of the anticoagulant and thrombin generation.