PhaseBio Pharmaceuticals has announced the EU expansion of its pivotal Phase III REVERSE-IT trial of its lead product candidate, bentracimab, for reversal of antiplatelet effects of ticagrelor.
A novel, human monoclonal antibody fragment, bentracimab demonstrated immediate and sustained reversal of the antiplatelet effects of Brilinta (ticagrelor), in previous clinical trials.
Along with the company’s financing and co-development partner for the EU and China, SFJ Pharmaceuticals, PhaseBio has opened trial enrolment sites and initiated dosing the first patients.
The multi-centre, open-label, prospective single-arm trial will analyse reversal of the antiplatelet effects of ticagrelor with bentracimab in patients with uncontrolled major or life-threatening bleeding or those needing urgent surgery or invasive procedure.
PhaseBio Pharmaceuticals president and CEO Jonathan Mow said: “The first patient dosed in the European Union is a significant milestone for the global development of bentracimab, given that the largest population of patients on P2Y inhibitors like ticagrelor reside in Europe.
“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.”
Bentracimab was studied in Phase I and Phase II clinical trials and showed the potential to bring life-saving therapeutic benefit through an immediate and sustained reversal of the antiplatelet activity of ticagrelor.
It could alleviate concerns on bleeding risks linked to the use of antiplatelet drug.
Furthermore, in a translational study, the product candidate attained equivalent reversal of branded ticagrelor and multiple ticagrelor generics.
The Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to bentracimab in April 2019.
In October 2019, PhaseBio dosed the first patient in a Phase IIb clinical trial of PB2452.
Last March, PhaseBio commenced the Phase III REVERSE-IT trial, to support a Biologics License Application for bentracimab in major bleeding and urgent surgery indications.