MALVERN, PA — PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS) recently announced topline data from its Phase 2b clinical trial of bentracimab, which was conducted in healthy, older volunteers 50-80 years old. The Phase 2b trial is a multi-center, randomized, double-blind, placebo-controlled study with 150 subjects receiving bentracimab and 50 subjects receiving placebo after all were pretreated with dual antiplatelet therapy composed of ticagrelor and low-dose aspirin. The Phase 2b pivotal trial was conducted concurrently with the company’s ongoing REVERSE-IT Phase 3 pivotal trial of bentracimab, as agreed upon with the U.S. Food and Drug Administration (FDA) following an End-of-Phase 1 meeting in July 2019. Bentracimab is a novel, recombinant, human monoclonal antibody antigen-binding fragment designed to reverse the antiplatelet activity of ticagrelor in major bleeding and urgent surgery situations.
The Phase 2b trial achieved its primary endpoint. The primary efficacy endpoint 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). VerifyNow is also the primary measurement used to evaluate efficacy in the ongoing REVERSE-IT Phase 3 trial.
Treatment with bentracimab in the Phase 2b trial had a safety profile consistent with the Phase 1 and 2a trials previously completed by the company, with no drug-related serious adverse events or thrombotic events reported in the trial. The most common adverse events were injection site bruising and headache, with similar rates seen in both the placebo and active-treatment arms.
These new data 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 Phase 2a trial, also conducted in healthy, older (ages 50-80) subjects on dual antiplatelet therapy of ticagrelor and low-dose aspirin. More than 300 subjects have been treated with bentracimab across the Phase 1, 2, and 3 clinical trials that comprise the bentracimab development program. Additional information on the Phase 2b trial can be found on www.ClinicalTrials.gov using the identifier NCT04122170.
“The favorable results we observed in the Phase 2b trial of bentracimab are an encouraging continuation of those that we have seen throughout the clinical development program,” said John Lee, M.D., Ph.D., Chief Medical Officer of PhaseBio. “These results are a critical step along our path towards potential regulatory approval, and we are pleased with the observations we have seen to date.”
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 will be presented on Monday, November 15, 2021, during a late-breaking science session at the American Heart Association’s Scientific Sessions 2021. The Company is commencing preparation of a Biologics License Application (BLA) and, depending on the results of REVERSE-IT, is targeting a BLA submission to the FDA in mid-2022.
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