Bentracimab in Phase 3 REVERSE-IT Trial with Deepak L. Bhatt, MD, MPH, MBA

Bentracimab, a novel drug designed to reverse ticagrelor’s antiplatelet effects, demonstrated rapid and sustained efficacy in the REVERSE-IT trial, according to data presented at the American College of Cardiology (ACC) 2025 Annual Scientific Sessions.

The trial showed use of bentracimab restored normal blood clotting within minutes, making it a potential breakthrough for patients on ticagrelor requiring urgent surgery or experiencing major bleeding, according to lead investigator Deepak L. Bhatt, MD, MPH, MBA, director of Mount Sinai Fuster Heart Hospital and the Dr. Valentin Fuster Professor of Cardiovascular Medicine at the Icahn School of Medicine at Mount Sinai.

Developed by SFJ Pharmaceuticals and set for US commercialization by SERB Pharmaceuticals, bentracimab is under review by the US Food and Drug Administration (FDA) following submission of a Biologics License Application in August 2024. At the time of filing to the FDA, no reversal agent exists for ticagrelor, making bentracimab a promising candidate to fill this gap.

A multicenter, open-label study, REVERSE-IT evaluated bentracimab’s ability to reverse ticagrelor’s effects among 226 patients who received ticagrelor within the previous 3 days and either needed surgery or another invasive procedure that could not be delayed or were experiencing major bleeding.

The trial’s primary endpoint was platelet inhibition reduction, which showed a statistically significant decrease within 4 hours of administration (P < .0001). Hemostasis rates were 94.3% overall, with 100% in surgical patients and 83.1% in those with major bleeding.

Further analysis indicated 18% of surgical patients and 12% of bleeding patients experienced serious treatment-related adverse events, but none withdrew from the study due to these effects. Importantly, no allergic reactions were reported.

For more on the study and how it could precipitate change in management of these patients, check out our interview with Bhatt.

Relevant disclosures for Bhatt include Amarin, AstraZeneca, Sanofi, Pfizer, Roche, Amgen, and Eli Lilly and Company, among others.

References

1. DL Bhatt. Bentracimab for Ticagrelor Reversal in Patients Undergoing Urgent Surgery – The Main Results Of The Phase 3 Reverse-it Trial. Presented at: American College of Cardiology (ACC.25) Annual Scientific Session. March 29 – 31, 2025. Chicago, Il.

2. Campbell P. Reverse-it: Bentracimab effective in reversing ticagrelor antiplatelet effects. HCP Live. March 29, 2025. Accessed March 29, 2025. https://www.hcplive.com/view/reverse-it-bentracimab-effective-in-reversing-ticagrelor-antiplatelet-effects.