Phasebio Announces Interim Results from Pivotal Reverse-It Phase 3 Trial of Bentracimab for the Reversal of Antiplatelet Effects of Ticagrelor in Patients Requiring Urgent Surgery or Experiencing Uncontrolled Major or Life-Threatening Bleeding
November 15, 2021 at 10:01 pm IST
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PhaseBio Pharmaceuticals, Inc. announced interim results from REVERSE-IT. REVERSE-IT is PhaseBio?s ongoing pivotal Phase 3 trial designed to study the reversal of the antiplatelet effects of ticagrelor with lead product candidate bentracimab in patients who present with urgent surgery or an invasive procedure or experiencing uncontrolled major or life-threatening bleeding. The prespecified interim analysis of 150 enrolled patients demonstrated that bentracimab achieved the primary endpoint of the trial by immediately and sustainably reversing the antiplatelet effects of ticagrelor. As measured by the point-of-care VerifyNow PRUTest platelet function assay, a 135% reduction in platelet inhibition (P<0.001) was observed within five to ten minutes after initiation of bentracimab infusion and sustained through all timepoints over 24 hours. More than 90% of eligible patients achieved the co-primary endpoint of the trial, defined as good or excellent hemostasis within 24 hours of initiation of bentracimab therapy (P<0.001). Thrombotic events were reported in 5.3% of patients, with none resulting in death or considered by investigators to be related to bentracimab. Bentracimab was generally well tolerated, with only five non-serious adverse events, reported in three patients, considered by investigators to be related to bentracimab. The most common adverse events were related to pain associated with surgical procedures. The results were presented by Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional Cardiovascular Programs at Brigham and Women?s Hospital and professor at Harvard Medical School, during a Late-Breaking Science Session at the 2021 American Heart Association Scientific Sessions and have been accepted for publication in NEJM Evidence, a new digital journal from the NEJM (New England Journal of Medicine) Group.
PhaseBio Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on the development and commercialization of novel therapies for cardiovascular diseases. Its lead product candidate, bentracimab (also known as PB2452), is a novel reversal agent for the antiplatelet drug ticagrelor. Ticagrelor is an antiplatelet therapy widely prescribed to reduce the rates of death, heart attack and stroke in patients with acute coronary syndrome (ACS), or who have previously experienced a heart attack. Ticagrelor binds to platelets to prevent them from forming blood clots that could restrict blood flow. The Company is also developing its preclinical product candidate, PB6440, an oral selective aldosterone synthase inhibitor for treatment-resistant hypertension. The Company is leveraging ELP biopolymer technology to evaluate additional preclinical and discovery-stage candidates. Its focus is on proteins and peptides that are scientifically or clinically validated.
Phasebio Announces Interim Results from Pivotal Reverse-It Phase 3 Trial of Bentracimab for the Reversal of Antiplatelet Effects of Ticagrelor in Patients Requiring Urgent Surgery or Experiencing Uncontrolled Major or Life-Threatening Bleeding