Portola Initiates Phase 2 Study To Evaluate Andexanet Alfa - Quick Facts

(RTTNews) - 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.