PhaseBio Pharmaceuticals Inc. (NASDAQ: PHAS), in partnership with SFJ Pharmaceuticals, China, and European Union, has announced preliminary results from Rapid and SustainEd ReVERSal of TicagrEor Intervention Trial (REVERSE-IT).
PhaseBio studied its lead candidate bentracimab REVERSE-OT study
REVERSE-IT is a Phase 3 trial being conducted by PhaseBio to see if the antiplatelet effects of ticagrelor can be reversed with the lead product candidate bentracimab in patients who are undergoing an invasive procedure or emergency surgery or who are experiencing uncontrolled life-threatening or major bleeding.
The company’s Chief Medical Officer John Lee said, “The data presented today from the Phase 3 REVERSE-IT trial of bentracimab are a continuation of the favorable results we’ve seen in the Phase 1, Phase 2a and Phase 2b trials that have been completed to date. These interim data continue to support the potential of bentracimab to help address a clear unmet need for patients on ticagrelor worldwide who lack an effective reversal agent. Having the ability to immediately restore platelet function, and ultimately achieve hemostasis in patients taking ticagrelor who require urgent surgery or an invasive procedure or experience uncontrolled major or life-threatening bleeding, would be significant for cardiologists, surgeons and, most importantly, patients.”
Bentracimab reversed ticagrelor’s antiplatelet effects
Bentracimab accomplished the trial’s primary goal by reversing the antiplatelet effects of ticagrelor rapidly and sustainably, according to a prespecified interim analysis of 150 recruited patients. As determined by the point-of-care test In the VerifyNow® PRUTest® platelet function assay, a 135 percent platelet inhibition reduction was detected after five to ten minutes of the start of bentracimab infusion and was sustained throughout the course of 24 hours.
Dr. Deepak Bhatt, who presented the data during the 2021 American Heart Association Scientific Sessions, commented, “With no approved reversal agents for oral P2Y12 inhibitors, patients who are prescribed these medications to reduce the risk of cardiac events are at increased risk for spontaneous major bleeding events, and physicians are faced with a complex dilemma of balancing bleeding risk and thrombotic risk, should these patients require urgent surgery.”
