PhaseBio Announces Positive Results from Phase 2b Trial for Bentracimab
Results presented on
Trial achieved primary reversal endpoint in older volunteers
Bentracimab was well tolerated in the Phase 2b trial, with no drug-related serious adverse events or thrombotic events reported
The primary efficacy endpoint for the Phase 2b trial was reversal of ticagrelor’s inhibition of platelet function in actively treated subjects versus placebo as measured using the point-of-care VerifyNow® PRUTest® platelet function assay (VerifyNow). In the Phase 2b trial, bentracimab significantly restored platelet function within five minutes of administration (p<0.001), as measured by multiple assays including VerifyNow. The reversal results were tightly correlated across all assays used in the study to measure platelet function. VerifyNow is also the primary measurement used to evaluate efficacy in the ongoing REVERSE-IT Phase 3 trial.
There were no drug-related serious adverse events or thrombotic events reported in the Phase 2b trial. Overall, bentracimab appeared well tolerated, with subjects reporting only non-serious adverse events. The most-commonly reported adverse events were injection site bruising and headache, with similar rates seen in both the placebo and active-treatment arms. There was no significant difference between bentracimab and placebo for any of the adverse events reported.
“The positive data from this Phase 2b trial of bentracimab build on the prior results that have already been published in the
These complete safety and efficacy data from the Phase 2b trial are consistent with results from PhaseBio’s previously completed Phase 1 trial, conducted in healthy younger volunteers treated with ticagrelor alone and not aspirin, and its Phase 2a trial, conducted in healthy, older (ages 50-80) subjects on dual antiplatelet therapy of ticagrelor and low-dose aspirin and with topline results previously announced for the Phase 2b trial on
“The Phase 2b trial of bentracimab is a key component of our pivotal development program and we are pleased with the results presented by
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 this antiplatelet drug.
Bentracimab is currently being evaluated in the REVERSE-IT study, a global Phase 3, 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 for enrollment in the REVERSE-IT study at major health centers worldwide. Patients with reported use of ticagrelor within the prior three days who require urgent ticagrelor reversal are eligible for enrollment. A prespecified interim analysis from the REVERSE-IT trial was presented on
About Bentracimab (PB2452)
Bentracimab is a novel, recombinant, human monoclonal antibody antigen-binding fragment designed to reverse the antiplatelet activity of ticagrelor in patients who present with uncontrolled bleeding or require surgery. In a Phase 1 clinical trial, bentracimab demonstrated the potential to bring life-saving therapeutic benefit through immediate and sustained reversal of ticagrelor’s antiplatelet activity, mitigating concerns regarding bleeding risks associated with the use of this antiplatelet drug. Data from the Phase 1 clinical trial of bentracimab in healthy volunteers was published in the
About PhaseBio
PhaseBio is located in
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(610) 981-6506
john.sharp@phasebio.com
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