Portola Pharmaceuticals, Inc. today announced that it has initiated a Phase 2 study evaluating the safety and effectiveness of PRT4445, its universal antidote for Factor Xa inhibitor anticoagulants, in healthy volunteers who have been administered approved and investigational Factor Xa inhibitors, including the oral investigational drug apixaban and Portola's oral investigational drug betrixaban.
…Multiple cohorts are planned for the Phase 2 study, which is expected to be completed in 2013. The first cohort will test PRT4445 with apixaban to evaluate further the safety of PRT4445 and the dose required to reverse the anticoagulant effect of apixaban[Eliquis]. Portola announced in November that it had entered into a clinical collaboration agreement with Bristol-Myers Squibb and Pfizer for the apixaban cohort of the Phase 2 study [#msg-81069705].
As noted in #msg-81069705, I don’t think PRT4445 will be able to salvage Portola’s Betrixaban program, but it may end up helping Eliquis.
Portola inks Xarelto-antidote collaboration with JNJ/Bayer that mirrors the Eliquis-antidote deal Portola inked with PFE/BMY in Nov 2012 (#msg-81069705):
The collaboration will be in effect throughout the Phase 2 study, which is scheduled to be completed in the second half of 2013. The study is designed to demonstrate the safety of PRT4445 at several different doses and its ability to reverse the anticoagulant activity of XARELTO. Bayer and Janssen will make an undisclosed cash payment to Portola and will provide development and regulatory guidance for the study. Portola retains all global development and commercialization rights for PRT4445.