ARCA biopharma, Inc. provided an update on the ASPEN-COVID-19 Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for patients hospitalized with severe COVID-19. The Company announced that the Data and Safety Monitoring Committee (DSMC) has completed a pre-specified interim analysis and, based on the DSMC?s review of approximately 75% of the projected final efficacy and safety data, recommended completion of the clinical trial with no modifications to the trial design. The rNAPc2 development program has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA). The Company now anticipates completion of target enrollment of 160 patients by year end 2021 and reporting of topline data in the first quarter of 2022. ASPEN-COVID-19 is a Phase 2b randomized, multi-center, international clinical trial evaluating two dose regimens of rNAPc2 versus heparin in approximately 160 hospitalized SARS-CoV-2 positive patients that also have an elevated D-dimer level. The primary endpoint of the trial 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 anti-coagulant commonly given to any patient hospitalized in the United States for COVID-19.