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news.Portola Pharmaceuticals has initiated a Phase III trial designed to evaluate the safety and efficacy of its investigational Factor Xa inhibitor reversal agent 'andexanet alfa' with Bristol-Myers Squibb (BMS) and Pfizer's Factor Xa inhibitor Eliquis (apixaban).
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Andexanet alfa, which secured breakthrough therapy designation from the US FDA, is being developed 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 immediate surgery.
The company is pursuing an Accelerated Approval pathway for andexanet alfa, which is the only agent that has showed reversal of the anticoagulation activity of Factor Xa inhibitors as measured by biomarkers, including anti-Factor Xa activity, in human studies.
The randomized, double-blind, placebo-controlled Phase III trial is designed to evaluate the efficacy of andexanet alfa in older healthy volunteers (ages 50-75 years) as showed by biomarker endpoints, including anti-Factor Xa levels, plasma free fraction of the anticoagulant and thrombin generation.
Portola executive vice president of R&D John Curnutte said the start of the company’s first Phase III trial 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.
"We are strategically focused on using biomarker and genetic approaches in our clinical development programs to identify the patients who will most likely benefit from our products and potentially accelerate their approval," Curnutte said.
The company said that about 32 healthy volunteers will be given Eliquis 5mg twice daily and then randomized in a 3:1 ratio to andexanet alfa administered as a 400mg IV bolus or to placebo, in the first part of the trial.
In the second part, around 32 healthy volunteers will be randomized in a 3:1 ratio to andexanet alfa administered as a 400mg IV bolus followed by a continuous infusion of 480mg at 4mg/min for 120 minutes or to placebo.
Participants in the trial will be followed for up to 43 days to assess safety.
The company intends to report initial data from the first part of the study, in which andexanet alfa is administered as a bolus infusion, in the fourth quarter of 2014, followed by bolus-plus-continuous infusion data from the second part of the trial in early 2015.