Portola Pharmaceuticals (PTLA) announced it has initiated a Phase 2 proof-of-concept study to evaluate andexanet alfa, the company's investigational Factor Xa inhibitor reversal agent, as a reversal agent for Daiichi Sankyo's oral, once-daily, direct Factor Xa inhibitor edoxaban in healthy volunteers. The company is pursuing an Accelerated Approval pathway for andexanet alfa.
Portola is developing andexanet alfa, an FDA-designated breakthrough therapy, as 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 who require emergency surgery.
In the randomized, double-blind, placebo-controlled, cohort dose-escalation Phase 2 study, healthy volunteers will be treated on days 1-6 with edoxaban 60 mg once a day and then randomized in a 6:3 ratio to intravenous andexanet alfa or placebo on day 6. The first dose cohort will evaluate a 600 mg bolus dose of andexanet alfa or placebo in 9 healthy volunteers. Pharmacodynamic and safety data will be collected through day 48.
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May 01, 2026 15:54 ET Central banks dominated the economics news flow this week with almost all major ones announcing their latest policy decisions and many boosted expectations for a rate hike in June. In other news, several countries released the preliminary data for first quarter economic growth. In the U.S., comments by Fed Chair Jerome Powell were also in focus as his term ends this month.