The results of the study showed that PB2452 acts to quickly reverse the effect of ticagrelor as a blood thinner, which is critically important in cases where bleeding turns uncontrollable, according to a new paper published in the New England Journal of Medicine.
Investors applauded the results, sending PhaseBio shares up 57% to $5.85 in afternoon trade.
Details of the trial were published in a paper titled, “An Antibody-based Ticagrelor Reversal Agent in Normal Volunteers” and were presented by Dr Deepak Bhatt, executive director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital and a professor at Harvard Medical School in a featured research session at the American College of Cardiology’s 68th Annual Scientific Session in New Orleans.
“Patients taking ticagrelor to reduce the risk of a cardiac event are currently without an effective method to reverse its antiplatelet effects, which increase the risk of spontaneous major bleeding and can quickly produce life-threatening bleeding should they require emergency surgery,” said Bhatt in a statement.
“The results from the Phase 1 trial demonstrate that intravenous PB2452 provided immediate and sustained reversal of ticagrelor antiplatelet activity, thereby potentially reducing the bleeding risk associated with ticagrelor,” Bhatt added.
Mitigating bleeing risk of antiplatelet drugs
The Phase 1 trial evaluated intravenous PB2452 as a ticagrelor reversal agent, with 64 healthy volunteers between the ages of 18 and 50 receiving either PB2452 or a placebo. PB2452’s abilities have the potential to increase the safety of ticagrelor and mitigate concerns about the bleeding risk associated with antiplatelet drugs. At the moment, there are no approved reversal agents for ticagrelor or any other antiplatelet drugs.
The study showed that PB2452 reversed the antiplatelet effects of ticagrelor without drug-related serious adverse effects, dose-limiting toxicities or infusion-related reactions.
On the back of the success of the Phase 1 study, a Phase 2a trial of PB2452 is set to kick off in the first half of this year.
PhaseBio, which has offices in Malvern, Pennsylvania and San Diego, California, specializes in the commercialization of therapies to treat orphan diseases, with a focus on cardiopulmonary disorders.
Contact Ellen Kelleher at [email protected]