PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS) has announced that the US FDA has granted breakthrough yherapy designation for PB2452—a novel reversal agent for the antiplatelet drug ticagrelor. Breakthrough therapy designation is designed to expedite the development and review of promising new drugs for serious or life-threatening conditions, when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
According to a press release, the breakthrough therapy designation for PB2452 was supported by Phase 1 trial results, in which PB2452 achieved immediate and sustained reversal of ticagrelor’s antiplatelet effects. The results from this trial were recently published in the New England Journal of Medicine and presented in a featured clinical research session at the American College of Cardiology’s 68th Scientific Session (ACC.19).
John Lee, chief medical officer of PhaseBio, says: “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. 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. Breakthrough Therapy designation supports our goal of making the first approved reversal agent for ticagrelor available to patients and physicians as soon as possible. We look forward to working closely with the FDA throughout the expedited development process.”