Shares of PhaseBio Pharmaceuticals, Inc. (NASDAQ: PHAS) jumped on Tuesday after the firm announced preliminary results from its mid-stage trial for dual antiplatelet therapy of the blood thinner ticagrelor and low-dose aspirin, which helps prevent heart attacks and strokes in patients with heart problems.
Specifically, the firm presented data from its Phase 2a clinical trial of PB2452, which is the first trial of PB2452 to include older (ages 50-64) and elderly (ages 65-80) subjects on dual antiplatelet therapy of ticagrelor and low-dose aspirin.
Subjects in the trial resemble the patient population most likely to be treated with ticagrelor and potentially benefit from PB2452, if approved. In the trial, statistically significant reversal of ticagrelor was achieved within five minutes of initiation of a PB2452 infusion and lasted for over 20 hours. Platelet function was normalized within 15 minutes following initiation of PB2452 infusion and remained normal for more than 20 hours.
So far, PB2452 has been generally well-tolerated in the Phase 2a trial, with only minor adverse events reported. These new data are consistent with results from PhaseBio’s previously published Phase 1 trial conducted in healthy younger volunteers treated with ticagrelor alone and not aspirin.
John Lee, M.D., Ph.D., chief medical officer of PhaseBio, commented:
For patients taking antiplatelet therapies such as ticagrelor, it is currently recommended that they stop their antiplatelet regimen for at least five days prior to undergoing surgery to reduce the risk of major bleeding. This isn’t an option for patients requiring urgent or emergency surgery. For patients experiencing major bleeding, there are currently no proven methods to reverse the effects of antiplatelet agents. 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. We look forward to reporting full results from the Phase 2a trial at an upcoming medical congress.
Shares of PhaseBio were up Tuesday morning about 6% to $13.03, with a 52-week range of $2.55 to $16.65.