Phase III REVERSE-IT study of PB 2452 meets primary endpoint in life-threatening bleeding.

The prespecified interim analysis of 150 enrolled patients (142 of whom enrolled requiring urgent surgery or an invasive procedure and eight of whom enrolled with uncontrolled major or life-threatening bleeding) 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 (VerifyNow), 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.></0.001).></0.001)>

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.