Novel Reversal Agent for Ticagrelor Gets FDA’s Breakthrough Tx Designation

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.

“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.”

For more information visit phasebio.com.