Boehringer Ingelheim has reported positive updated results from its ongoing Phase III RE-VERSE AD study of Praxbind (idarucizumab) to treat patients in emergency settings.
Praxbind is a humanised antibody fragment designed as a specific reversal agent to dabigatran.
It binds specifically to dabigatran molecules and neutralise their anticoagulant effect without interfering with the coagulation cascade.
The Phase III RE-VERSE AD study enrolled 494 patients who were administered with dabigatran and had uncontrolled or life-threatening bleeding or needed emergency surgery or an invasive procedure.
Results suggested that praxbind met its primary endpoint of completely reversing the anti-coagulant effect of dabigatran within four hours as measured by diluted thrombin time (dTT) and ecarin clotting time (ECT).
The reversal was noted immediately after Praxbind was administered.
Sidney Kimmel Medical College at Thomas Jefferson University professor of emergency medicine and lead investigator of RE-VERSE AD Dr Charles Pollack said: “The availability of idarucizumab as a reversal agent for dabigatran is an important development in anticoagulation care, and RE-VERSE AD is the most robust examination of its real-world use and impact.
“These results further support that, although idarucizumab is likely to be rarely used in light of the safety profile of dabigatran, a specific reversal agent provides an important therapeutic option for physicians and patients.”