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news.Portola Pharmaceuticals has collaborated with Bayer HealthCare and Janssen Pharmaceuticals for a Phase 2 study of universal factor Xa inhibitor antidote, PRT4445.
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The study will conducted in healthy volunteers who received oral Factor Xa inhibitor Xarelto (rivaroxaban).
Phase 2 study designed to assess the safety of varying doses of PRT4445 and its efficacy in reversing the anticoagulant activity of Xarelto, is expected to be completed in the second half of 2013.
Portola chief executive officer William Lis said, "Oral Factor Xa inhibitors are a major advance over standard therapies such as warfarin and enoxaparin, but there is an important unmet medical need for an antidote to help manage patients if they require their anticoagulant to be reversed."
Portola, which retains global development and commercialization rights of PRT4445, will obtain an undisclosed amount in addition to development and regulatory guidance for the study from Bayer and Janssen.