Bentracimab is a novel recombinant human monoclonal antibody antigen-binding fragment designed to reverse the antiplatelet effect of ticagrelor in severe bleeding and urgent surgical procedures. Alfasigma has now acquired the European license for bentracimab from PhaseBio.
Alfasigma has an exclusive license agreement with PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS) for the commercialization of bentracimab in 49 countries in Europe and other key markets. Bentracimab is a novel human monoclonal antibody fragment that has demonstrated immediate and prolonged reversal of the antiplatelet effect of Brilinta®/Brilique® (ticagrelor) in previous clinical trials. PhaseBio is a biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases. It will be responsible for developing bentracimab and obtaining marketing authorization from the European Medicines Agency (EMA) and the Medicines and Health Products Regulatory Agency (MHRA). Subsequently, the approval is granted to Alfasigma. Alfasigma is responsible for obtaining regulatory approval in other territories not covered by EMA or MHRA approvals, and for obtaining and maintaining regulatory approvals necessary for the marketing and sale of the product, including price negotiations and post-marketing obligations. This agreement is another important step on our way to consolidate Alfasigma among the major international specialty companies following the recent acquisition of Lumeblue® .
Bentracimab is currently in late-stage clinical development in the REVERSE-IT trial (Rapid and SustainEd ReVERSal of TicagrElor – Intervention Trial). REVERSE-IT is a multicenter, open-label, prospective, single-arm, phase III study to evaluate the reversal of the antiplatelet effect of ticagrelor with bentracimab in patients presenting with uncontrolled major or life-threatening bleeding or who require urgent surgery or invasive procedures. Bentracimab has already been evaluated in Phase I and Phase II clinical trials and has shown the potential to provide a life-saving therapeutic benefit by immediately and persistently reversing the antiplatelet effect of ticagrelor, which may reduce concerns about the bleeding risks associated with the use of this antiplatelet agent. In addition, bentracimab achieved equivalent reversal of branded and several generic ticagrelor drugs in a translational study.
Source: “Alfasigma Acquires European License for Bentracimab from PhaseBio”, 06/22/2021.
CARDIOVASC 2021; 20(2): 32
