The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to PB2452 (PhaseBio), an investigational reversal agent for ticagrelor.

Currently, there are no FDA-approved reversal agents for ticagrelor, a P2Y12 platelet inhibitor. PB2452, a recombinant, human monoclonal antibody antigen-binding fragment, has been shown to reverse the antiplatelet activity of ticagrelor in early studies, including a phase 1 first-in-human trial.

Results from the phase 1 study (N=64) showed that volunteers administered PB2452 had a significantly greater increase in platelet function than those given placebo. Reversal was observed within 5 minutes of PB2452 initiation and lasted for >20 hours (P<.001). With regard to safety, the most frequently reported treatment-emergent adverse event was infusion site bruising.

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“Breakthrough Therapy designation for PB2452 highlights the critical unmet need for a therapy to reverse the antiplatelet activity of ticagrelor, which is widely prescribed to patients with acute coronary syndrome or a history of heart attack,” said John Lee, MD, Chief Medical Officer of PhaseBio. “The results from the phase 1 clinical trial of PB2452 demonstrated immediate and sustained reversal of the antiplatelet activity of ticagrelor, which could mitigate bleeding concerns associated with use of ticagrelor.”

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