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Portola Pharmaceuticals Inc Announces Positive Phase 2 Study Results Showing Factor Xa Inhibitor Antidote PRT4445 Reverses Anticoagulant Activity Of Eliquis

Tuesday, 2 Jul 2013 07:34am EDT 

Portola Pharmaceuticals Inc announced positive pharmacodynamic and safety data from a Phase 2 proof-of-concept study of investigational Factor Xa inhibitor antidote PRT4445 in healthy volunteers who were administered the Factor Xa inhibitor Eliquis (apixaban). Results showed greater than a 95% reversal of the anticoagulant activity of Eliquis was achieved within two minutes of intravenously administered high-dose PRT4445, which has a tentatively approved International Nonproprietary Name (INN) of andexanet alfa. Bleeding events occur infrequently in patients taking Factor Xa inhibitors (1-4% per year in several clinical studies involving patients taking a Factor Xa inhibitor on a chronic basis). Development of andexanet alfa, specifically designed to reverse the activity of Factor Xa inhibitors, may provide an antidote for patients who experience an uncontrolled bleeding event or require emergency surgery. Phase 2 Study Design and Results- randomized, placebo-controlled, double-blind, cohort dose-escalation Phase 2 study, 27 healthy volunteers were treated on days 1-6 with Eliquis 5 mg twice a day (to steady state) and then randomized in a 6:3 ratio to intravenous andexanet alfa (in 3 different dose cohorts -- 90 mg, 210 mg or 420 mg) or saline on day 6, three hours after receiving the last Eliquis dose. Two minutes after administration of 420 mg andexanet alfa (n=6), anticoagulant activity of Eliquis decreased by greater than 95% as measured by anti-Factor Xa activity. 

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