An investigational monoclonal antibody called bentracimab can safely and effectively reverse potentially catastrophic bleeding complications linked to ticagrelor, a common drug used to treat patients with acute coronary syndromes, prior heart attack, stroke, and coronary artery disease.
Those are the findings from a multicentre international clinical trial analysing bentracimab, the first experimental treatment of its kind. The REVERSE-IT trial results were presented in a late-breaking clinical trial session at the American College of Cardiology (ACC) 2025 scientific session (29–31 March, Chicago, USA).
“If approved by the US Food and Drug Administration (FDA), bentracimab could be a new life-saving option for someone having life-threatening bleeding, such as a brain haemorrhage,” says study chair Deepak L Bhatt (Mount Sinai Fuster Heart Hospital and Icahn School of Medicine at Mount Sinai, New York, USA). “The same could be true in patients who need urgent or emergency surgery following a heart attack, such as coronary artery bypass grafting. Use of this drug could also allow earlier surgery in patients taking ticagrelor, by reversing its effect and allowing the surgeon to operate earlier.
“Right now, there is no effective way to reverse the antiplatelet effect of ticagrelor. If approved, bentracimab would be able to fill this clinical need.”
Ticagrelor is an effective, reversible oral platelet inhibitor for cardiac patients; like all antiplatelet agents, it can cause bleeding. Because of its specific molecular structure, researchers were able to develop bentracimab as a monoclonal antibody that reverses its effect when given intravenously to patients already taking ticagrelor. Bentracimab works by binding to ticagrelor and its active metabolite, effectively reversing the antiplatelet effects of ticagrelor and restoring platelet function.
In this phase 3 trial, researchers analysed 226 ticagrelor patients dosed with bentracimab, of whom 212 met eligibility criteria and had an independent assessment of the degree of bleeding control. They included 141 surgery and 71 bleeding patients.
In all patients, platelet function was quickly and significantly restored within minutes. Effective bleeding control was achieved in 94.3% of the total eligible patients: 100% in the surgery group and 83% in the bleeding patients.
“This is the first antiplatelet reversal agent. If approved, in the right patients it could prevent or treat catastrophic bleeding events in patients receiving ticagrelor. The availability of a reversal agent might make ticagrelor the preferred antiplatelet agent, especially once it becomes available as a generic medication,” adds Bhatt.
SFJ Pharma funded this study. Dr. Bhatt is a paid consultant for this company.
