ARCA Biopharma Expects Data Readout From Mid-Stage COVID-19 Trial In Q1 2022

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ARCA biopharma Inc ABIO has completed enrollment of 160 patients in ASPEN-COVID-19 Phase 2b trial evaluating rNAPc2 for patients hospitalized with COVID-19. 

  • The Company anticipates reporting topline data in Q1 of 2022.
  • The trial's primary endpoint is the change in D-dimer level from baseline to Day 8 relative to standard of care heparin. 
  • D-dimer is a biomarker commonly used for assessing coagulation activation, which is elevated in approximately 40% to 75% of hospitalized COVID-19 patients and is associated with adverse clinical outcomes.  
  • Heparin is an anticoagulant commonly given to any patient hospitalized for COVID-19.  
  • Other objectives of Phase 2b are to assess safety, determine the optimal dose regimen for a potential Phase 3 trial and evaluate multiple additional clinical endpoints. 
  • rNAPc2 is a small recombinant protein. It is a potent, selective inhibitor of tissue factor (TF), which plays a central role in the inflammatory response to viral infections.
  • Related Link: ARCA Biopharma Stock Gains As Safety Committee Recommends COVID-19 Trial To Continue Unchanged.
  • Price Action: ABIO shares are down 1.10% at $2.25 during the market session on the last check Thursday.
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