PhaseBio Pharmaceuticals (NASDAQ:PHAS) announces that the Investigational New Drug (IND) application for bentracimab has been approved by China National Medical Products Administration (NMPA).
Bentracimab is a novel, human monoclonal antibody fragment that in earlier trials has shown immediate and sustained reversal of the antiplatelet effects of Brilinta/Brilique (ticagrelor).
With approval of the IND, PhaseBio and development partner SFJ Pharmaceuticals are authorized to begin enrolling patients in China into the ongoing late-stage trial of the drug.
The companies anticipate enrolling the first patients at sites in China later in 2021, after the trial has reached its interim enrollment milestone expected in mid-2021.
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PhaseBio had entered into an exclusive licensing agreement with Alfasigma S.p.A for the commercialization of bentracimab, in June.