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Portola announces phase 3 study of Factor Xa inhibitor antidote

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Portola Pharmaceuticals announced the initiation of a phase 3 study of its Factor Xa inhibitor reversal agent andexanet alfa.

The double blind trial will assess the efficacy and safety of andexanet alfa in the reversal of the anticoagulation effects of apixaban (Eliquis, Bristol-Myers Squibb and Pfizer) among patients requiring emergency surgery or experiencing major bleeding. Andexanet alfa is the first drug to demonstrate reversal of Factor Xa inhibitor activity, as indicated by biomarkers, in human study, according to a press release.

The first part of the trial will include approximately 32 healthy volunteers aged 50 to 75 years who will receive 5 mg apixaban twice daily. These participants will then be randomly assigned at a 3:1 ratio to 400 mg andexanet alfa via IV bolus or placebo. The second part of the study will include approximately 32 healthy volunteers randomized at a 3:1 ratio to 400 mg andexanet alfa via IV bolus, followed by continuous infusion of 480 mg andexanet alfa at 4 mg/min for 120 minutes, or placebo. Safety will be assessed during a 43-day follow-up period.

The trial follows results from two phase 2 studies, in which andexanet alfa temporarily reversed anti-Factor Xa activity associated with apixaban and rivaroxaban (Xarelto, Janssen Pharmaceuticals) among healthy volunteers. This reversal was observed both temporarily via IV bolus infusion and permanently following an extended infusion, according to the release.

The company plans to begin a phase 3 trial assessing the use of andexanet alfa with rivaroxaban during the first half of 2014.

“The initiation of our first phase 3 study for andexanet alfa represents a significant milestone in the clinical development of this innovative drug to address the important unmet medical need for a Factor Xa inhibitor antidote,” John C. Curnutte, MD, PhD, executive vice president of research and development at the company, stated in the release. He added that initial data from the first part of the study is anticipated for the fourth quarter of the year, with the results from the second part to follow during early 2015.