MALVERN, PA — PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, announced that it has expanded its pivotal Phase 3 REVERSE-IT trial for its lead product candidate bentracimab (formerly PB2452) into Canada, where the first patients outside of the United States have now been enrolled and dosed. Bentracimab is a novel, human monoclonal antibody fragment that in earlier trials has shown immediate and sustained reversal of the antiplatelet effects of Brilinta® (ticagrelor).
“Brilinta is the best-in-class antiplatelet drug for patients with acute coronary syndrome (ACS), recent stent placement, or a history of myocardial infarction. Like all antiplatelet therapies, it does create some challenges for patients with serious bleeding events or who need urgent surgery,” said John Lee, M.D., Ph.D., Chief Medical Officer of PhaseBio. “In these situations, doctors need an intervention that immediately and sustainably reverses the antiplatelet activity of ticagrelor; this is something that currently does not exist. Bentracimab has the potential to be an important solution as it provides immediate and sustained restoration of platelet function, with potential utility across a broad spectrum of bleeding events, urgent surgeries and invasive procedures.”
“With cardiovascular disease representing a leading cause of death in Canada, as in the rest of the world, we expect to continue to see widespread utilization of P2Y12 inhibitors like ticagrelor to help prevent adverse cardiovascular events in vulnerable patients. While ticagrelor is highly efficacious it poses increased risk of serious bleeding, like other P2Y12 inhibitors. The promise of a potential reversal agent addresses a significant unmet clinical need for a large number of patients at risk of severe bleeding or those who may suffer a serious bleeding episode while on ticagrelor,” said Subodh Verma, M.D., Ph.D., a cardiac surgeon and Professor at the University of Toronto, and a member of the REVERSE-IT steering committee and Canadian national lead investigator. “I am delighted that about 20 sites in Canada will participate in this important and potentially practice-changing clinical trial,” said Professor Verma.
“We have seen in prior trials that bentracimab provided immediate restoration of platelet function and believe that it can help ticagrelor patients receive the urgent care they need in cases of acute bleeding or in need of an urgent procedure,” said Dr. C. David Mazer, a Professor of Anesthesiology at the University of Toronto and Canadian investigator on REVERSE-IT. Dr. Mazer continued, “We are delighted to be the first Canadian REVERSE-IT site to participate in the development of this critical therapy for patients in need.”
Jonathan Mow, Chief Executive Officer of PhaseBio added: “With a generic version of Brilinta under regulatory review in Canada and a best-in-class efficacy profile relative to other P2Y12 inhibitors, we anticipate significant growth in market share for ticagrelor in Canada and a growing need for a novel reversal agent like bentracimab. We view the expansion of REVERSE-IT enrollment into Canada as an important milestone for the global bentracimab program.”
Bentracimab has been studied in Phase 1 and Phase 2 clinical trials and has demonstrated the potential to bring life-saving therapeutic benefit through immediate and sustained reversal of the antiplatelet activity of ticagrelor, potentially mitigating concerns regarding bleeding risks associated with the use of antiplatelet drugs. Additionally, in a translational study, bentracimab achieved equivalent reversal of branded ticagrelor and multiple ticagrelor generics. AstraZeneca reported net sales of $845 million for Brilinta in the first half of 2020, which represents a 15% increase over the prior year’s global total and an increase of 34% in emerging markets.
The Phase 3 clinical study is called REVERSE-IT (Rapid and SustainEd ReVERSal of TicagrElor – Intervention Trial). REVERSE-IT is a multi-center, 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 centers worldwide. Patients with reported use of ticagrelor within the prior 3 days who require urgent ticagrelor reversal will be eligible for enrollment.
More information about the REVERSE-IT Phase 3 trial is available at ClinicalTrials.gov, using the identifier NCT04286438.
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