ARCA Biopharma Stock Gains As Safety Committee Recommends COVID-19 Trial To Continue Unchanged

  • The Data and Safety Monitoring Committee (DSMC) has completed a pre-specified interim analysis for ARCA biopharma Inc's ABIO ASPEN-COVID-19 Phase 2b trial evaluating rNAPc2, a small recombinant protein for COVID-19.
  • Based on the review of approximately 75% of the projected final efficacy and safety data, DSMC recommended completing the trial with no modifications to the trial design. 
  • The rNAPc2 development program has been granted FDA Fast Track designation. 
  • The Company anticipates completing the target enrollment of 160 patients by year-end 2021 and reporting topline data in Q1 of 2022.
  • ASPEN-COVID-19 trial is evaluating two dose regimens of rNAPc2 versus heparin in hospitalized positive patients who also have an elevated D-dimer level. 
  • 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 a commonly used anticoagulant for COVID-19.  
  • Price Action: ABIO shares are up 19.1% at $3.12 during the premarket session on the last check Friday.
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