PhaseBio Pharmaceuticals has expanded its pivotal phase 3 REVERSE-IT trial for bentracimab into the European Union (EU), having opened trial sites for enrollment and begun dosing its first patients. Bentracimab is a novel, human monoclonal antibody fragment that in earlier clinical trials has shown immediate and sustained reversal of the antiplatelet effects of ticagrelor.
REVERSE-IT (Rapid and SustainEd ReVERSal of TicagrElor–Intervention Trial) is a Phase 3, multicentre, open-label, prospective single-arm trial designed to study reversal of the antiplatelet effects of ticagrelor with bentracimab in patients who present with uncontrolled major or life-threatening bleeding or who require urgent surgery or invasive procedure.
Approximately 200 patients are being targeted to be enrolled from major health centres worldwide. Patients with reported use of ticagrelor within the prior three days who require urgent ticagrelor reversal will be eligible for enrolment.
“We are pleased to announce the expansion of our global Phase 3 study of bentracimab into a number of EU countries. The first patient dosed in the EU is a significant milestone for the global development of bentracimab, given that the largest population of patients on P2Y12 inhibitors like ticagrelor reside in Europe,” said Jonathan Mow, president & CEO of PhaseBio Pharmaceuticals.
“To help better manage patients who benefit from antiplatelet therapy, physicians across the globe need a reversal agent that can immediately intervene in the case of a spontaneous bleeding event or before an urgent surgery. We are confident in the clinical profile of bentracimab and pleased to expand its clinical development into the EU as we work to develop the first ticagrelor-specific antiplatelet reversal agent.”
John Lee, chief medical officer of PhaseBio Pharmaceuticals, added: “The successful development of a novel, specific reversal agent for patients on ticagrelor antiplatelet therapy has the potential to change the way the healthcare system currently manages patients with acute coronary syndrome (ACS), a history of myocardial infarction or established coronary artery disease. With the potential to eliminate procedure delays due to pre-operative washout periods that may increase thrombotic risk and prolong in-hospital stays, an effective reversal agent such as bentracimab could enable surgeons to perform necessary surgical procedures on these patients without waiting the currently-recommended five‒seven days prior to surgery. Additionally, having the ability to immediately restore platelet function in patients who are experiencing a major spontaneous bleeding event would represent a paradigm shift in how these patients are managed, given that currently available options are limited to blood transfusions and supportive care. We are excited to be able to bring this important investigational therapy to our investigators in Europe and are looking forward to the continued expansion of the global REVERSE-IT Phase 3 trial, with sites in China expected to open later this year.”
In a press statement, PhaseBio Pharmaceuticals noted that bentracimab has been studied in Phase 1 and Phase 2 clinical trials, in which it has demonstrated sustained reversal of the antiplatelet activity of ticagrelor, potentially mitigating concerns regarding bleeding risks associated with the use of the antiplatelet drug.