PHAS - PhaseBio Pharmaceuticals' bentracimab treatment meets main goal in mid-stage trial
PhaseBio Pharmaceuticals (NASDAQ:PHAS) announces that its bentracimab treatment met the primary endpoint in a mid-stage trial conducted in healthy, older volunteers 50-80 years old. The Phase 2b trial is a multi-center, randomized, double-blind, placebo-controlled study with 150 subjects receiving bentracimab and 50 subjects receiving placebo after all were pretreated with dual antiplatelet therapy composed of ticagrelor and low-dose aspirin. The Phase 2b trial achieved its primary endpoint of reversal of ticagrelor’s inhibition of platelet function in actively treated subjects versus placebo as measured using the point-of-care VerifyNow PRUTest platelet function assay (VerifyNow). The most common adverse events were injection site bruising and headache, with similar rates seen in both the placebo and active-treatment arms. The company is commencing preparation of a Biologics License Application (BLA) and, depending on the results of REVERSE-IT, is targeting a BLA submission to the FDA in mid-2022.
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PhaseBio Pharmaceuticals' bentracimab treatment meets main goal in mid-stage trial