PLEASANTON, CA, March 29, 2025 (GLOBE NEWSWIRE) -- SFJ Pharmaceuticals (SFJ) and SERB Pharmaceuticals (SERB) announced today the final results of the pivotal Phase 3 REVERSE-IT trial designed to study the reversal of the antiplatelet effects of ticagrelor with bentracimab - a human monoclonal antibody fragment (Fab) that targets ticagrelor and its active metabolite specifically - in patients in need of urgent surgery or an invasive procedure or experiencing major bleeding. The trial achieved its primary endpoint, demonstrating significant, rapid restoration of platelet function in both patients requiring urgent surgery as well as those with major bleeding.1
The primary efficacy endpoint of the REVERSE-IT trial was minimum percent inhibition of P2Y12 reactivity units (PRU) within four hours after start of bentracimab infusion, compared to baseline.1 The mean difference in the primary efficacy endpoint was -122.94 (P<0.0001) and the mean (standard deviation) PRU increased from 91.7 (79.78) pre-treatment to ≥180 (lower limit of normal PRU value) within 5-10 minutes (P<0.0001) and remained ≥180 throughout the 16-hour infusion and ≥8 hours thereafter.1
The trial also achieved its secondary efficacy endpoint with 94.3% of eligible patients, 100% of patients requiring urgent surgery and 83.1% of patients experiencing major bleeding, achieving effective (excellent or good) hemostasis within 24 hours as assessed using GUSTO bleeding criteria in the surgery group and Connolly criteria in the bleeding group.1
“These Phase 3 data demonstrate that bentracimab could be an effective option to manage major or life-threatening bleeding in patients on ticagrelor, with a consistent safety profile,” said Dr. Deepak L. Bhatt, MD, MPH, MBA, Director of the Mount Sinai Fuster Heart Hospital and the Dr. Valentin Fuster Professor of Cardiovascular Medicine at the Icahn School of Medicine at Mount Sinai, Principal Investigator on the Phase 3 REVERSE-IT trial, and a paid consultant for SFJ Pharmaceuticals. “Discontinuation of ticagrelor and waiting for its anti-platelet effects to disappear over three to five days is not always feasible when patients require urgent surgery or are experiencing major bleeding. Bentracimab’s ability to normalize platelet function within 5-10 minutes and maintain normal platelet function throughout the infusion to facilitate hemostasis delivers a much-needed solution to better manage patients in need.”
Bentracimab also demonstrated an overall favorable safety profile and was generally well tolerated.1 No serious adverse reactions or allergic reactions occurred in patients treated with bentracimab.1 The rate of thrombotic events in this study (4.0%) was similar to the typical baseline for patients' underlying conditions.1 Ticagrelor was reinitiated or other P2Y12 inhibitors were started in 69.5% patients within 7 days after the bentracimab infusion.1
“The rapid onset of action of bentracimab and its relatively short half-life allows for the quick normalization of platelet function when needed. Stopping bentracimab after surgery or once an acute medical event is under control restores the desired anti-platelet effect of ticagrelor. This would allow doctors to manage both the risk of bleeding and the risk of thrombosis, increasing the value proposition of this medicine,” said Dr. Barbara White, President and Chief Executive Officer of SFJ.
“There is a significant unmet need to reverse ticagrelor’s effects in patients who require non-deferrable surgery or experience major bleeding,” said Vanessa Wolfeler, Chief Executive Officer, SERB Pharmaceuticals. “These results reinforce the promise of bentracimab, and SERB is committed to bringing this product to healthcare providers treating patients facing rare emergencies and conditions.”
These data were presented at the American College of Cardiology Annual Scientific Session in the Late-Breaking Clinical Trials session on March 29, 2025, from 11:30 a.m. to 12:30 p.m. CT, and are consistent with previous data and past studies. Phase 1 data regarding bentracimab were published in the New England Journal of Medicine in 2019,2 and the first interim analysis of the REVERSE-IT trial were published in the New England Journal of Medicine Evidence in 2021.3 Bentracimab received Breakthrough Therapy Designation from the FDA in 2019, was granted Priority Review in 2024 and Orphan Drug Designation on March 18, 2025.
About the REVERSE-IT Trial
The Phase 3 REVERSE-IT trial is a multi-center, open-label, prospective single-arm study of reversal of the antiplatelet effects of ticagrelor with bentracimab in patients who require urgent surgery or invasive procedure or are experiencing major bleeding.1 The trial enrolled 226 patients across the United States, Canada, the European Union and China.1 On Day 1, patients received an intravenous (IV) infusion comprised of an initial IV bolus of 6 grams (g) infused over 10 minutes for rapid reversal, followed immediately by a 6g IV loading infusion over four hours and then a 6g IV maintenance infusion over 12 hours.1
About Ticagrelor (BRILINTA®)
Ticagrelor, marketed by AstraZeneca as BRILINTA®, is P2Y12 platelet inhibitor indicated: 1) to reduce the risk of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. BRILINTA® also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS; 2) to reduce the risk of a first MI or stroke in patients with coronary artery disease at high risk for such events; and 3) to reduce the risk of stroke in patients with acute ischemic stroke or high-risk transient ischemic attack.
About SFJ Pharmaceuticals
SFJ is a global drug development company, which provides a unique and highly customized clinical development partnering model for the world’s top pharmaceutical and biotechnology companies. SFJ provides at-risk funding and the global clinical development management and oversight necessary for regulatory submission for some of the most promising drug development programs of pharmaceutical and biotechnology companies. SFJ’s mission is to leverage its financial strength and global team of pharmaceutical development experts to accelerate the development of life-saving and life-enhancing drugs for the benefit of physicians and the patients they serve. www.sfj-pharma.com
About SERB Pharmaceuticals
SERB acquired exclusive U.S. rights to RETRIG from SFJ in 2023 and will commercialize RETRIG in the U.S. The company equips healthcare providers worldwide with life-saving medicines for rare conditions and emergencies. For over 30 years we have consistently provided emergency medicines, medical countermeasures, and the world’s leading portfolio of antidotes. With a strong presence in the U.S., Europe, and the Middle East, along with a global network of distribution partners, we make essential medicines available in over 100 countries. Our proven ability to acquire, develop, manufacture, launch and commercialize specialist medicines allows us to meet critical medical needs with urgency. By expanding our reach through selective acquisitions and entering new markets, we’re not just supplying medicine; we’re raising the standard of care for more patients around the world. Learn more at https://SERB.com.
For further information contact:
SFJ Pharmaceuticals: Jonathan DeBenedetto, Chief Financial Officer
admin@sfj-pharma.com; Tel: +1-925-223-6233
SERB Pharmaceuticals: Chris Sampson, Director of Corporate Communications chris.sampson@serb.com; Tel: +44 (0)7773 251 178
Media: Jaryd Leady, Spectrum Science Communications, jleady@spectrumscience.com; Tel: +1-856-803-7855
References
- Bhatt DL. The Main Results of the Phase 3 REVERSE-IT Trial. Late-Breaking Clinical Trials II [Session 103]. In: American College of Cardiology’s Annual Scientific Session & Expo; March 29-31, 2025; Chicago, IL.
- Bhatt DL, Pollack CV, Weitz JI, et al. Antibody-Based Ticagrelor Reversal Agent in Healthy Volunteers. N Engl J Med. 2019;380(19):1825-1833. doi:10.1056/NEJMoa1901778
- Bhatt DL, Pollack CV, Mazer CD, et al. Bentracimab for Ticagrelor Reversal in Patients Undergoing Urgent Surgery. NEJM Evidence. 2022;1(3). doi:10.1056/evidoa2100047
Chris Sampson, DIrector of Corporate Communications SERB Pharmaceuticals +44 7773 251 178 chris.sampson@serb.com Jonathan DeBenedetto, Chief Financial Officer SFJ Pharmaceuticals +1-925-223-6233 admin@sfj-pharma.com Jaryd Leady Spectrum Science Communications +1-856-803-7855 jleady@spectrumscience.com
