PhaseBio Pharmaceuticals (NASDAQ:PHAS) reported initial results from its Phase 2a trial assessing PB2452’s ability to reverse the effects of the antiplatelet drug, ticagrelor, in subjects 50-to-80 years of age.
Ticagrelor is administered to patients to reduce the risk of blood clot formation, but also increases the risk of spontaneous bleeding. PB2452, a monoclonal antibody fragment, binds to ticagrelor to reverse its antiplatelet effect.
The trial, which included patients on both ticagrelor and low-dose aspirin, demonstrated a statistically significant reversal of ticagrelor within 5 minutes of PB2452 infusion that was sustained for more than 20 hours. Platelet function was normalized by 15 minutes following PB2452 infusion and remained normal for more than 20 hours.
“For patients experiencing major bleeding, there are currently no proven methods to reverse the effects of antiplatelet agents,” John Lee, PhaseBio’s CMO, said in a statement.
“If approved, PB2452 could help address these critical unmet medical needs by enhancing the safety profile of ticagrelor, which has the potential to become the only antiplatelet therapy on the market with a specific reversal agent,” he added.
PhaseBio received FDA breakthrough designation for PB2452 to reverse the effects of ticagrelor in April 2019.